Clinical Research Directory

Evaluation of LB-208 (HTR1B Antagonist) in Adult Patients With Relapsed or Refractory Solid Tumours and Lymphoma

This clinical study is investigating a new experimental medicine called LB-208, developed for the treatment of advanced solid tumors and lymphomas in adult patients whose disease has relapsed, not responded to treatment, or for whom no suitable standard treatment option remains. This is a Phase I trial, meaning it is an early-stage study in humans. At this stage, the main goal is not yet to prove definitive effectiveness, but rather to better understand the safety of the medicine, how it behaves in the body, and what dose may be most appropriate for future studies. LB-208 is an oral compound that works by blocking a target called HTR1B. According to the protocol, it is considered a first-in-class treatment, meaning it belongs to a new therapeutic category and has a novel mechanism of action in this setting. The drug is given orally, once a day, under fasting conditions, in continuous 28-day cycles, with no breaks between cycles. The study is open-label and uses a dose-escalation design. This means that both the medical team and the patients know which treatment is being given, and that the first groups of patients receive lower doses, which are gradually increased if tolerance is acceptable. The design used is the well-known 3+3 model: initially, 3 patients are treated at a given dose level. If no major safety concerns are seen, the dose is increased for the next group. If significant side effects appear, more patients may be enrolled at the same dose level or the escalation strategy may be adjusted. This approach helps identify the maximum tolerated dose and the recommended dose for future studies. The main objective of the trial is to assess the safety and tolerability of LB-208 and determine the dose that can be recommended for further clinical development. To do this, researchers closely monitor adverse events, laboratory test results, physical examinations, vital signs, electrocardiograms, and other clinical parameters. A particularly important part of the study is the identification of dose-limiting toxicities (DLTs), which are significant side effects occurring during the first treatment cycle and help define whether a dose is tolerable. In addition to safety, the study also examines pharmacokinetics, meaning how the medicine is absorbed, distributed, metabolized, and eliminated by the body. Blood samples are collected at different time points to measure how much LB-208 is present in the bloodstream and for how long. This information is essential to understand how the treatment works in practice and to help optimize dosing. The study also includes pharmacodynamic and exploratory biomarker analyses. These assessments aim to better understand whether the medicine is having the expected biological effect and whether there are tumor or blood markers that may help identify patients more likely to benefit from treatment in future studies. Although this early trial is not primarily designed to prove anti-tumor efficacy, researchers will also evaluate preliminary signs of clinical activity, such as tumor shrinkage, disease stabilization, duration of response, and progression-free survival. Patients taking part in the study must meet a series of eligibility criteria. In general, they must be adults with advanced cancer for which standard options are no longer effective or appropriate, have a good enough general condition to undergo experimental treatment, and meet the required organ function and laboratory parameters. As in all clinical trials, there are also exclusion criteria intended to protect patient safety, such as certain uncontrolled medical conditions, specific previous treatments, or other factors that could interfere with interpretation of the results. Participation in this trial may offer some patients access to an innovative therapy that is not otherwise available. However, because it is a Phase I study, there are also important uncertainties. The benefits cannot be guaranteed, the most appropriate dose is still being defined, and unexpected side effects may occur. For this reason, patients are followed very closely by the clinical team throughout the study. Overall, LB-208 / SERONCO-1 is an early clinical study designed to determine whether this new oral HTR1B inhibitor can be administered safely, to define the best dose for future development, and to generate the first clinical information on its potential role in treating advanced cancer. The knowledge gained from this study may help guide the next stages of development and determine whether LB-208 should move forward into later-phase trials.

A Study to Investigate the Safety and Efficacy of KQB365 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies

The goal of this clinical trial is to learn if KQB365 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB365. The main questions it aims to answer are: * What is the safe dose of KQB365 by itself, in combination with cetuximab, or in combination with KQB198? * Does KQB365 alone, in combination with cetuximab, or in combination with KQB198 decrease the size of the tumor? * What happens to KQB365 in the body? Participants will: * Receive KQB365 infusion weekly alone, in combination with cetuximab, or in combination with oral KQB198. * Visit the clinic about 9 times in the first 6 weeks, and then once every week after that.

SND002 Cell Injection in Participants With Advanced Malignant Solid Tumors

This is a phase 1, multicenter, open-label, single-arm study evaluating SND002 Cell Injection in participants with advanced malignant solid tumors that have progressed after standard treatment or for whom no standard treatment is available. SND002 Cell Injection is an investigational product made from a participant's own immune cells (T cells). These cells are collected from a lymph node that drains the tumor, expanded in a laboratory, and then given back to the same participant by intravenous infusion. Because the cells come from the participant, the approach is intended to help the participant's immune system recognize and attack the tumor. The study has two parts. In Part A, small groups of participants receive increasing numbers of cells to identify the dose range that is safest and best tolerated. In Part B, additional participants with colorectal cancer, gastric cancer, or other solid tumors receive the dose range selected in Part A, to learn more about antitumor activity. Before the infusion, participants receive a short course of chemotherapy to prepare the body for the cells. After the infusion, participants receive interleukin-2 injections for several days and are monitored closely. Safety is assessed for 28 days after the infusion, and participants are then followed for up to 1 year to assess tumor response and survival. The main questions are (1) what side effects occur, how severe they are, and what dose range is recommended for further study, and (2) in the expansion part, how many participants experience a reduction in tumor size. Approximately 69 to 78 participants will be enrolled at multiple hospitals in China. Follow-up continues for up to 1 year after the infusion.

Predicting Reactions and Effects of Drugs Immunotherapy and Complications Through Oncosafety (PREDICTO Clinical Study)

Immune Checkpoint Inhibitors (ICI) have revolutionized cancer therapy, providing unprecedented responses in a wide range of malignancies. However, they induced various immune-related adverse events (iRAE) that can be life-threatening. About 20% of patients treated with an ICI monotherapy, and up to 60% of patients treated with a combination of ICIs, experienced a severe iRAE. Most side effects are reversible if managed early, but can affect survival and quality of life, leading to treatment interruptions or hospitalization. Some of these irAEs, particularly those affecting hormonal functions, may be irreversible and persist even after treatment discontinuation. The development of predictive biomarkers of such toxicities is an unmet medical need. The variety of mechanisms involved in iRAE, and the lack of effective animal models, could probably explain why the topic remains largely unexplored. To date, some biomarkers predictive of the occurrence of iRAE, irrespective of the type of organ affected, have been identified by state-of-the-art techniques on small cohorts prior to treatment initiation, but none is individually robust enough to be used in daily practice. We hypothesize that a signature derived from the integrative analysis of various biological parameters (immunomonitoring, auto-immunity features, viral monitoring, microbiota monitoring, fragmentome analysis, pharmacokinetics, radiomics and genetics), available in routine hospital practice, could answer this question, and thus enable the development of specific prevention strategies The objectives are : Primary objective: Identify a baseline predictive signature for severe iRAE, irrespective of the type of organ affected. Secondary objectives: * Identify a predictive signature for severe iRAE including baseline and T1 data, irrespective of the type of organ affected. * Identify a baseline predictive signature for organ-specific severe iRAE. * Identify a predictive signature for organ-specific severe iRAE including baseline and T1 data. * Identify a baseline predictive signature for severe iRAE, irrespective of the type of organ affected, for patient receiving an anti-PD(L)1 in monotherapy. * Identify a baseline predictive signature for severe iRAE, irrespective of the type of organ affected, for patient receiving an anti-PD(L)1 in combination. * Identify a baseline predictive signature for severe iRAE, irrespective of the type of organ affected, for each specific immunotherapy received. * Compare the predictive signatures between responders and non-responders according to RECIST 1.1 in order not to overlook the influence of clinical response on the variability observed. * Describe the results obtained for each biological parameter between severe irAEs and non-severe irAEs patients. * Describe patient-reported outcomes and quality of life parameters.

Imaging Study of [89Zr]DFO-YS5 for Cancer Detection

This is a single-center, pilot, PET-imaging study of the novel radiotracer 89Zirconium-89 DFO conjugated to the YS5 monoclonal antibody (\[89Zr\]DFO-YS5) in participants with nerve sheath tumor, bladder cancer, or advanced solid tumor neoplasms.

The Application of 18F-G1 PET/CT Targeting Granzyme B in the Pan-cancer Immunotherapy

The purpose of this study is to explore the effectiveness of 18F-G1 PET/CT in patients with solid tumors and hematological malignancies receiving immunotherapy

A Study of DC50292A Tablet in Patients With MTAP-deleted Advanced or Metastatic Solid Tumors

This study employs a non-randomized, open-label design to evaluate the safety, tolerability, pharmacokinetic (PK) profile, and preliminary efficacy of DC50292A tablets in patients with MTAP-deficient advanced or metastatic solid tumors. The study consists of two parts: dose escalation and dose expansion.

A First-In-Human, Phase 1 Study Evaluating Oral TACC3 PPI Inhibitor, AO-252, in Advanced Solid Tumors With or Without Brain Metastases

The purpose of this study is to assess the safety, tolerability and efficacy of the study drug AO-252 and identify the best dose for use in future studies.

Olutasidenib DDI Study in Patients With IDH1 Mutation Positive Malignancies

A open-label drug-drug interaction (DDI) study to evaluate the effects of olutasidenib on the pharmacokinetics (PK) of a CYP450 and OATP1B1 probe substrate cocktail in participants with IDH1 mutation-positive malignancies.

Pralsetinib DDI Study in Patients With Advanced or Metastatic Solid Tumors

An open-label drug-drug interaction study to evaluate the effects of pralsetinib (Gavreto) on the pharmacokinetics of a CYP450 probe substrate cocktail and, in female participants, a hormonal probe substrate, in participants with rearranged during transfection (RET) fusion- or mutation-positive solid tumors

GRACE: A Phase 1/2a Study of VTRU200 in Relapsed/Refractory AML, High-risk MDS, DLBCL Post CART Failure and Advanced Solid Tumors

About this study This is the first study of VTRU200 in people. The main purpose of this study is to find a safe dose of VTRU200 and learn how the medicine behaves in the body. Researchers will also look for early signs that it may help treat cancer. VTRU200 is an experimental immunotherapy. It is designed to help the body's immune system find and destroy cancer cells while limiting effects on healthy cells. Unlike many cancer treatments that target a single protein, VTRU200 recognizes stress signals that are commonly found on cancer cells. These signals include certain sugars (called glycans) and fats (called phospholipids) that are present on many types of cancer cells but are uncommon on normal healthy cells. VTRU200 also attaches to immune cells called T cells and helps direct them to attack cancer cells. Because VTRU200 targets features that are shared by many cancers, it may continue to work even if cancer cells lose or change individual proteins that other treatments depend on. Who can take part? This study is for people with certain blood cancers that have come back after treatment or have not responded to available treatments. These include: Acute myeloid leukemia (AML) Higher-risk myelodysplastic syndromes (HR-MDS) Diffuse large B-cell lymphoma (DLBCL) that has returned after CAR T-cell therapy Later parts of the study may also include adolescents and children with AML. What will happen during the study? Participants will receive VTRU200 through a vein (intravenous infusion). The study will begin by giving small doses to help determine the safest dose for future participants. If those doses are well tolerated, later participants may receive higher doses. Researchers will: Monitor participants closely for side effects. Perform blood tests to measure how VTRU200 moves through and leaves the body. Measure how the immune system responds to treatment. Check whether the cancer shrinks, disappears, or remains under control. Participants may receive multiple treatment cycles if they continue to benefit and do not have unacceptable side effects. What are the possible benefits? VTRU200 may or may not help participants. Information learned from this study may help develop new treatments for people with these cancers in the future. What are the possible risks? Because VTRU200 is being tested in humans for the first time, not all side effects are known. Possible risks include reactions related to activation of the immune system, infusion-related reactions, laboratory test changes, and other side effects. Participants will be monitored closely throughout the study, and medical care will be available if side effects occur. Brief Study Description This first-in-human, open-label, Phase 1/2a study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary antitumor activity of VTRU200 in participants with relapsed or refractory acute myeloid leukemia (AML), higher-risk myelodysplastic syndromes (HR-MDS), or diffuse large B-cell lymphoma (DLBCL) following CAR T-cell therapy. VTRU200 is an investigational trispecific T-cell engager that binds stress-associated glycans, phosphatidylserine, and CD3 to redirect T cells toward cancer cells. The Phase 1 dose-escalation portion will determine the recommended Phase 2 dose (RP2D), followed by disease-specific expansion cohorts to further evaluate safety and preliminary antitumor activity. Why is this research important? Many blood cancers eventually stop responding to available treatments. Cancer cells can escape therapy by changing or losing the proteins that many current medicines target. VTRU200 is designed to recognize stress-related features that many cancer cells share rather than relying on a single protein target. Researchers hope this approach may reduce the chance of treatment resistance while limiting damage to healthy cells. This study will help determine whether VTRU200 can be given safely and whether it shows early signs of helping people with difficult-to-treat blood cancers.

A Clinical Study of GO321 in Patients With Advanced Solid Tumors

The goal of this clinical trial is to learn about the safety and tolerability of GO321 recombinant oncolytic virus injection, and if GO321 recombinant oncolytic virus injection works to treat advanced solid tumors in adults whose cancers have progressed after standard-of-care therapy. It will also learn about the pharmacokinetic features, viral shedding, immunogenicity of GO321, immune markers, and genomic and proteomic changes in patients. The main questions it aims to answer are: What safety issues and tolerability limitations do participants experience when receiving GO321 via intratumoral or intracavitary injection? Does GO321 have preliminary anti-tumor efficacy against advanced solid tumors resistant to standard treatment? What changes take place in viral distribution, viral shedding, immunity, blood immune markers, tumor or blood genomics and proteomics after GO321 administration? Researchers will assess different doses and dosing schedules of GO321 given by intratumoral or intracavitary injection across two study phases to find a suitable administration dose and regimen and verify the study endpoints. Participants will: Receive either a single injection of GO321 at different dose levels (in Part 1) or repeated GO321 injections at the recommended Phase 2 dose (in Part 2) by intratumoral or intracavitary routes; Complete scheduled hospital visits to undergo laboratory tests, imaging examinations and biological sample collection; Have their safety indicators, anti-tumor response, viral parameters, immune indicators and molecular profiles tracked throughout the study.

Exploring the Feasibility of Cerebrospinal Fluid (CSF) and Blood Plasma Liquid Biopsy in Patients With Metastatic Solid Tumours and Primary Central Nervous System (CNS) Tumours: A Pilot Study

This is a prospective, single-centre feasibility study of CSF ctDNA conducted at the Sunnybrook Odette Cancer Centre (SOCC), Toronto, Canada, including multiple solid tumor, stratified into cohorts according to CNS disease involvement, including leptomeningeal disease (Cohort A), parenchymal brain metastases (Cohort B), and no evidence of CNS metastases (Cohort C).

ECMO Use in Pediatric Oncology and HSCT Patients: A Descriptive and Comparative Analysis

This was an observational study, with a descriptive and comparative portion. The descriptive analysis, a large single center experience, examined bleeding complications, infectious rates, and survival outcomes in patients under 18 years old with an underlying oncologic diagnosis and/or hematopoietic stem cell transplant on Extracorporeal membrane oxygenation (ECMO). In a small multicenter cohort, the comparative analysis evaluated survival outcomes in this population with respiratory failure in the presence and absence of ECMO. Children's Mercy Kansas City served as the ECMO cohort; Cincinnati Children's Hospital Medical Center served as the matched non-ECMO cohort.

Clinical Evaluation of [68Ga]Ga-FFD PET Imaging in Healthy Volunteers and Patients With Solid Tumors

This is a prospective, single-center, open-label clinical study designed to evaluate the safety, biodistribution, radiation dosimetry, and diagnostic performance of \[68Ga\]Ga-FFD PET imaging. The study consists of two cohorts: healthy volunteers and adult patients with histologically or clinically confirmed malignant solid tumors. Healthy volunteers will undergo serial PET imaging to evaluate tracer biodistribution, pharmacokinetics, and radiation dosimetry. Patients will undergo \[68Ga\]Ga-FFD PET imaging in addition to standard-of-care \^18F-FDG PET imaging for assessment of lesion detection and diagnostic performance. Safety will be evaluated through adverse event monitoring, vital signs, laboratory tests, physical examinations, and electrocardiography. Diagnostic performance will be assessed using histopathology, conventional imaging, and clinical follow-up as the reference standard.

GKL-006Allo Injection in Patients With Advanced Solid Tumors

This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of GKL-006Allo Injection in participants with advanced solid tumors.

A Phase I/II Study of FG-M108 Plus FG-B901 in Advanced CLDN18.2-Positive Solid Tumors

This open-label, multicenter Phase I/II trial evaluates the combination of FG-M108 and FG-B901 in patients with unresectable locally advanced or metastatic solid tumors that are positive for Claudin 18.2 and have progressed on, are intolerant to, or lack standard therapy. The Phase I dose-escalation part (using a BF-BOIN design) assesses safety, tolerability, and pharmacokinetics, and determines the recommended Phase II dose (RP2D) of FG-B901 when given with fixed-dose FG-M108. The Phase IIa expansion cohorts, grouped by tumor type, further evaluate safety and preliminary efficacy, with antitumor activity measured by RECIST 1.1 and iRECIST, while also exploring biomarker correlates. Key eligibility requires CLDN18.2 positivity (≥10% tumor cells with ≥1+ membrane staining by IHC), ECOG performance status 0-1, and measurable disease. Up to approximately 30 participants will be enrolled per cohort in Phase IIa. The study aims to provide initial evidence on the combination's safety, tolerability, PK, immunogenicity, and clinical activity in this hard-to-treat population.

PROGRESS: Precision Oncology Using Genomic Reflexive Evaluations for Study Selection and Survival

This is a hybrid decentralized, single-arm, interventional study designed to evaluate the impact of precision medicine navigation and reflexive expert review of next-generation sequencing (NGS) for patients with stage IV solid tumor malignancies (breast, lung, colorectal, and bladder cancers). The purpose of this study is to investigate whether intervention from a centralized precision oncology navigator and expert review of NGS results by the precision oncology pharmacist will increase ordering of Level 1/2 genome informed therapy (GIT) compared to an estimated historical rate of 15%. Secondary endpoints will assess the impact of a centralized precision oncology navigator and expert review of NGS results on enrollment in biomarker-directed clinical trials and overall survival at 2 years after return of NGS results. The study will take approximately 12 months for enrolment and 2 years of follow-up after the date of NGS results.

Trial to Evaluate irAEs With Different Standard of Care Dosing Strategies of Standard of Care Immunotherapies

Phase 3/4 open label, randomized two cohort study (2 arms in each cohort). It is hypothesized that for people with a histologically or cytologically confirmed diagnosis of malignancy, the higher dose immunotherapy (every 6 weeks Pembrolizumab 400mg dose and every 4 weeks Nivolumab 480mg dose) has more immune-related adverse events irAEs compared to lower dose (every 3 weeks Pembrolizumab 200mg dose and every 2 weeks Nivolumab 240mg dose).

Ph. I/II Sodium Thiosulfate for OtoProtection During Cisplatin (STOP-CIS)

The purpose of this study is to assess the safety and effectiveness of a drug called Pedmark® sodium thiosulfate (STS) in reducing hearing impairment with standard of care cisplatin therapy. The safety and effectiveness of STS in reducing hearing loss has been well established in children and is approved for use in the pediatric and young adult population. However, information in adult patients is limited. As most cisplatin is administered in the adult population, this investigation would be of benefit.

A Study to Investigate the Safety and Efficacy of KQB548 in Participants With Advanced Solid Malignancies

The goal of this trial is to learn if KQB548 works to treat patients with advanced solid malignancies with a KRAS G12D mutation. It will also learn about the safety of KQB548. The main questions it aims to answer are: * What is the safe dose of KQB548? * Does KQB548 decrease the size of the tumor? * What happens to KQB548 in the body?

xDRIVE for Florida-based Cancer Patients

Through this study funded by the Florida Cancer Innovation Fund, First Ascent will demonstrate state-wide feasibility of providing xDRIVE Functional Precision Medicine + Artificial Intelligence platform by assessing patient clinical benefit and health economics impacts. As this is a feasibility study, results will be returned to the physician and the physician may use the data to inform the next line of treatment. The investigator will run a prospective single-arm feasibility study providing the xDRIVE FPM AI platform to n = 210+ cancer patients throughout the state of Florida, especially those from underserved populations (pediatric patients and patients in Black, Brown, Hispanic, and rural communities).

ALI Post Radiation Therapy in Patients With Lung and Esophageal Canter

The goal of this clinical research study is to learn if giving autologous lymphocyte infusions to patients who are receiving chemotherapy and radiation for non-small cell lung cancer or esophageal cancer is safe and effective.

ProAgio in Previously Treated Advanced Pancreatic Cancer and Other Solid Tumor Malignancies

The study is a first-in-human, Phase I study to assess the safety of ProAgio in participants with advanced solid tumor malignancies including pancreatic cancer.