Clinical Research Directory

Phase 1b/2 Study of Combination 177Lu Girentuximab Plus Cabozantinib and Nivolumab in Treatment naïve Patients With Advanced Clear Cell RCC

To learn if giving 177Lu girentuximab in combination with cabozantinib plus nivolumab can help to control advanced clear cell renal cell carcinoma (ccRCC).

Psilocybin-Assisted Psychotherapy in Patients With Advanced Cancer on Maintenance Therapy

To learn about the feasibility, safety, and effects of psilocybin-assisted psychotherapy on depression and/or anxiety in participants who are being treated for advanced cancer.

Study of AB598 Monotherapy and Combination Therapy in Participants With Advanced Cancers

The primary purpose of this study is to assess the safety and tolerability of AB598 in participants with advanced malignancies.

Phase 2 Basket Trial of Nab-sirolimus in Patients With Malignant Solid Tumors With Pathogenic Alterations in TSC1/TSC2 Genes (PRECISION 1)

A Phase 2 multi-center open-label basket trial of nab-sirolimus for adult and adolescent patients with malignant solid tumors harboring pathogenic inactivating alterations in TSC1 or TSC2 genes

A Study of MGC026 in Participants With Advanced Solid Tumors

The study is designed to understand the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of vobramitamab tavatecan (MGC026) in participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors The study has a dose escalation portion and a cohort expansion portion in Module A of the study. Combination therapy with pembrolizumab will occur in Module B of the study Participants will receive vobramitamab tavatecan by intravenous (IV) infusion. The dose of vobramitamab tavatecan will be assigned at the time of enrollment. Pembrolizumab will be administered at 200 mg every 3 weeks. Participants may receive up to 35 treatments if there are no severe side effects and as long as the cancer does not get worse. Participants will be monitored for side effects, and progression of cancer, have blood samples collected for routing laboratory work, and blood and tumor samples collected for research purposes.

Psilocybin in Cancer Pain Study

The overall objective of this study is to assess the feasibility, safety and preliminary efficacy of psilocybin-assisted therapy to alleviate opioid-refractory pain in patients with advanced-cancer. The name of the study intervention used in this research study is: Psilocybin (a tryptamine derivative)

A Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)

This open-label, multicenter, rollover study will provide continued treatment for participants deriving benefit from different therapies received in studies sponsored by Daiichi Sankyo, Inc. (DS) or DS/Astra Zeneca (AZ)-sponsored study.

Safety Study of Whole Body Hyperthermia for Advanced Cancer

Millions of patients die of cancer every year. There are several methods to treat cancer, including surgery, chemotherapy, radiotherapy and immunotherapy. Recently, hyperthermia therapy started playing a role in cancer therapy. It has shown effect in animal experiments and clinical practice. The sponsor has developed a novel device to use hyperthermia for advanced cancer. This study is to prove the safety in human patients of this device \& therapy and get the first data on efficacy.

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

This clinical trial is evaluating a drug called ART0380 in participants with advanced or metastatic solid tumors. The main goals of this study are to: * Find the recommended dose of ART0380 that can be given safely to participants alone and in combination with gemcitabine or irinotecan * Learn more about the side effects of ART0380 alone and in combination with gemcitabine or irinotecan * Learn more about the effectiveness of ART0380 alone and in combination with gemcitabine or irinotecan

Cancer Pain 101: A Digital, Asynchronous Intervention of Pain Management in Advanced Cancer

This is a Stage 1 study of a behavioral intervention, which means that a new intervention is being pilot tested to understand whether it is acceptable and feasible for people with advanced cancer to use. The purpose of this study is to evaluate whether a series of 3 10-minute videos may help improve prescription opioid pain management and opioid stigma for people living with advanced cancer. Approximately 45 participants will take part in this study at the University of Alabama at Birmingham. People who choose to participate in this study will complete a series of baseline questionnaires, and then will be randomized to one of two groups: 1) the group that gets the video intervention, or 2) the group that gets a written handout with information about cancer pain. About 4 weeks later, all participants will also be asked to fill out another series of questionnaires.

Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) Therapy for Patients With Advanced Cancer: A Randomized Controlled Trial

Phase II randomized controlled trial, followed by an open-label extension phase. In the main study, participants will receive either a single high or low dose of psilocybin in the context of Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) therapy. Upon completion of main study, participants who received the low dose will be offered a single high dose of psilocybin in the context of PEARL therapy (Open label extension study).

Psilocybin Therapy in Advanced Cancer

The purpose of this research is to study the safety and effects of single-dose psilocybin 25mg versus an active placebo (single dose niacin 100mg) in the treatment of anxiety, depression, and existential distress (i.e., loss of meaning and hope; fear of death) in advanced cancer (i.e., stage 3 or 4). Study medications will be administered in conjunction with brief psychotherapy that is designed to treat anxiety, depression and existential distress in advanced cancer.

Intrapleural Catheter Daily Versus Three Times a Week Drainage

The goal of this clinical research study is to learn if draining the IPC every day is better at than draining it 3 times a week.

Integrated Smartphone Technology to Alleviate Malignant Pain (I-STAMP) Testing

The purpose of the study is to evaluate if the smartphone app, I-STAMP (Integrated Smartphone Technology to Alleviate Malignant Pain), helps participants with cancer pain manage symptoms and keep track of medications.

A Feasibility Study of a Digitally-enabled Psychological Intervention for Demoralization in Advanced Cancer Patients

Advanced cancer is a leading cause of death worldwide and in China. Cancer patients often face reduced independence and self-care abilities, which may lead to psychological disturbances such as helplessness, hopelessness, or meaninglessness. This combination of these negative emotions is called demoralization. Approximately 35.8% of cancer patients experience demoralization, with higher rates in terminal stages. If unrecognized or untreated, it can increase physical and mental symptom burden, reduce quality of life, and even lead to suicide. To date, no professional bodies currently recommend treatment guidelines. One meta-analysis suggests that psychological interventions could significantly reduce demoralization; however, the requirement for in-person attendance may create accessibility challenges, potentially reducing the flexibility and acceptability of psychological interventions for cancer patients undergoing chemotherapy or receiving treatment at home. To address the identified literature gap, a co-designed digital psychological intervention was developed, and this study will evaluate its feasibility. A convenience sample of 30 advanced cancer patients meeting the inclusion criteria will be recruited from the oncology ward of a hospital in Shenzhen. Participants will receive five 30-45 minute sessions of a co-designed, digitally-enabled positive psychological intervention, delivered weekly over five weeks. A trained researcher will introduce the intervention before discharge and deliver it through a WeChat Mini Program in the patients' homes. The primary outcome will be feasibility (time to complete recruitment, eligibility rate, recruitment rate, retention rate, attendance rate, and acceptability rate). Secondary outcomes will be measured for preliminary intervention effectiveness on demoralization, suicidal ideation, and quality of life of advanced cancer patients at baseline (after collecting demographic information and written consent forms) and post-intervention. A separate researcher will conduct a descriptive qualitative evaluation with 12 participants to explore their experience of the intervention. Qualitative data will be audio-taped, transcribed verbatim, and analyzed using NVivo 14 through thematic analysis. Quantitative data will be entered into SPSS version 29.0. Descriptive statistics will be used to summarize the profiles of participants and outcomes.

An Open-Label Study to Evaluate PF-07994525 in Participants With Advanced Cancers

This is an open-label, dose escalation and dose expansion study evaluating the safety, tolerability, Pharmacokinetic (PK), Pharmacodynamic (PD), and antitumor activity of PF-07994525 in participants with R/R MM. The study will consist of 2 parts: Part 1 (Dose Escalation) will consist of PF-07994525 dose escalation to assess the safety, tolerability, and preliminary antitumor activity in participants with R/R MM. In Part 2 (Dose expansion), PF-07994525 may be evaluated in additional participants with R/R MM to further assess safety, PK, PD, and preliminary anti-tumor activity.

A Study of AB801 Monotherapy and Combination Therapy in Participants With Advanced Malignancies

The primary purpose of this study is to assess the safety and tolerability of AB801 in participants with advanced malignancies, and to determine a recommended AB801 dose for expansion.

Phase I Trial of Bevacizumab and Temsirolimus in Combination With 1) Carboplatin, 2) Paclitaxel, 3) Sorafenib for the Treatment of Advanced Cancer

The goal of this clinical research study is to find the highest tolerable dose of the combination of bevacizumab (Avastin) and temsirolimus (Torisel) that can be given with 1 of 3 other study drugs --carboplatin (Paraplatin), paclitaxel (Taxol), or sorafenib (Nexavar). The safety of these drug combinations will also be studied.

Methods of Identifying Effective Off-Guideline Treatments for Advanced Cancer Patients

Many FDA-approved drugs are not available to patients with a particular cancer because there has been no successful clinical trial conducted for that drug against that cancer. In the absence of such a successful clinical trial, the drug is not included in the National Comprehensive Cancer Network (NCCN) guidelines list of approved drugs for that cancer. The absence of a drug in the NCCN Guidelines for a particular cancer is usually not an indication that the drug has been shown to be ineffective for patients with that cancer. Rather, it is an indication that there is insufficient clinical trial evidence to include it. A drug that is FDA-approved for one or more cancers but is not in the NCCN Guidelines for a particular cancer is called an "off-guideline" drug for that cancer. This study is being done to measure and compare the reliability of multiple different treatment selection tests to predict a participant's response to an off- guideline cancer therapy. The results can guide oncologists to effective off-guideline drugs that would otherwise not be available to their advanced cancer patients. As this is an observational study, all the data gathered and analyzed will be generated in the normal practice of medicine, not by the study.

Resilience-Building for Advance Care Planning

The aims of this study are to (1) assess the feasibility, acceptability, and usability of the ROCKS intervention among patients with advanced cancer and their family caregivers through a randomized controlled trial in a cancer center setting; (2) evaluate the preliminary efficacy of ROCKS, as compared to usual care, on changes in completion of advance directives; and (3) explore the dyadic effects of resilience on self-efficacy, optimism, dyadic communication and coping, anxiety, and depression using an actor-partner interdependence model.

HALO Trial: Haloperidol vs Olanzapine in Hyperactive Delirium in Palliative Care Patients; A Multi-Centre, Randomised-Controlled Trial

1. Background and Clinical Need: Delirium is common at the end of life and is challenging to control. There is a clinical need to study the benefits of commonly used drugs like Haloperidol and Olanzapine in the management of hyperactive delirium in advanced cancer or end-stage organ disease patients in a scientifically robust manner. 2. Aims/Hypotheses: The investigators aim to study the effectiveness of Haloperidol compared with Olanzapine in the management of hyperactive delirium in advanced cancer or end-stage organ disease patients receiving palliative care. The investigators hypothesise that Olanzapine is as effective as Haloperidol in the control of hyperactive delirium. 3. Methods: The investigators will conduct a pragmatic, multi-centre, (hospital, inpatient hospice, community hospital) open-label randomised-controlled trial comparing the use of Haloperidol versus Olanzapine in advanced cancer or end-stage organ disease patients with hyperactive delirium. The primary outcome is the change in Richmond Agitation and Sedation Scale (RASS) scores among patients in each treatment group at 8 hours post-drug administration. The secondary outcome is the control of hyperactive delirium at 24, 48 and 72 hours using either Haloperidol or Olanzapine. The mean doses of Haloperidol and Olanzapine used as well as the volume of rescue Midazolam required as well as side-effects of the study medications, survival after enrolment into study will also be studied. 4. Significance to palliative care The results of this study will advance the knowledge of delirium management worldwide with regards to the efficacy of Haloperidol and Olanzapine in managing hyperactive delirium in patients with advanced cancer or end-stage organ disease. Haloperidol is used traditionally in palliative care for managing delirium. However, as a conventional anti-psychotic, it does cause extra-pyramidal side-effects. Olanzapine, a newer atypical anti-psychotic with a more favourable side-effect profile is being used increasingly in the control of delirium. These 2 commonly used drugs have never been compared head to head in a randomised-controlled, multi-centre study.

A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TST001 in Advanced or Metastatic Solid Tumors

This is an open-label, multi-center, Phase I trial of TST001. Subjects with locally advanced or metastatic solid tumors will be enrolled. The study will consist of two parts: Part A is dose escalation and dose expansion phase for mono-therapy, and Part B is dose escalation and dose expansion phase for combination therapy in gastric, gastroesophageal junction(G/GEJ) and biliary tract cancer, etc.

Combination of Osemitamab (TST001), Pembrolizumab and Chemotherapy as First-line Therapy in Advanced or Metastatic GC/GEJ Adenocarcinoma

Gastric/GEJ adenocarcinomas are aggressive tumors with a high probability of death. Current treatment guidelines include two-drug cytotoxic chemotherapy with a fluoropyrimidine (mFOLFOX6: capecitabine or fluorouracil) and a platinum-based agent (CapOx: oxaliplatin or cisplatin). In addition, the FDA has approved nivolumab, a PD-1 checkpoint inhibitor, in combination with chemotherapy as first line treatment for advanced or metastatic gastric/GEJ cancer. TST001 is a recombinant humanized monoclonal antibody against Claudin 18.2 (a tumor marker found in gastric/GEJ cancer. In this study, the combination therapy of chemotherapy or chemotherapy and pembrolizumab with and without TST001 could provide additional benefits to the management of these tumors.

Phase I Study of Oral Darinaparsin (ZIO-101-C)in Advanced Solid Tumors and Non-Hodgkin's Lymphomas

The study of Dariniparsin (ZIO-101-C) in Advanced Solid Tumors and Non-Hodgkin's Lymphomas