Clinical Research Directory

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors

This is a first-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of enzelkitug when administered as a single agent and in combination with atezolizumab or pembrolizumab in adult participants with locally advanced or metastatic solid tumors, including non small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma, triple-negative breast cancer (TNBC), esophageal cancer, gastric cancer, cervical cancer, colorectal cancer (CRC), urothelial carcinoma (UC), clear cell renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC). Participants will be enrolled in 2 stages: dose escalation and dose expansion.

A Study of [225Ac]Ac-AKY-2519 in Patients With B7-H3 Expressing Solid Tumors

This is a Phase 1b, 2-part, multi-center, open-label study to evaluate the safety, tolerability, dosimetry, and pharmacokinetics (PK) of \[64Cu\]Cu-AKY-2519 and/or \[225Ac\]Ac-AKY-2519, as well as the preliminary anti-tumor activity of \[225Ac\]Ac-AKY-2519 in participants with B7-H3 imaging positive solid tumors.

A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors

This is a Phase 1/2 open-label, multi-center, multi-national study with an initial dose escalation part to determine the recommended Phase II dose (RP2D) of MCLA-158 single agent in patients with mCRC. The dose escalation part has been completed and the RP2D will be further evaluated in an expansion part of the study. Cohorts of selected solid tumor indications for which there is evidence of EGFR dependency and potential sensitivity to EGFR inhibition will be evaluated including head and neck cancer and metastatic colorectal cancer (mCRC). The study will further assess the safety, tolerability, PK, PD, immunogenicity, and anti-tumor activity of MCLA-158 in monotherapy or in combination with other therapies.

177Lu-anti-PD-L1 sdAb in Metastatic Solid Tumors

This is a Phase 0/1, First-in-Human (FIH), study to evaluate safety, tolerability of 177Lu-RAD204 in participants with selected solid tumors, and to determine the MTD and/or recommended dose for future exploration.

Objective Response Rate of Ivonescimab With Chemotherapy in Locally Advanced Resectable Oral and Oropharyngeal Squamous Cell Carcinoma

To investigate the neoadjuvant chemoimmunotherapy regimen of Ivonescimab combined with chemotherapy (Paclitaxel plus Cisplatin/Carboplatin) for the treatment of locally advanced resectable oral squamous cell carcinoma and oropharyngeal squamous cell carcinoma.

TMV Vaccine Alone or With Toripalimab-tpzi for Recurrent Head and Neck Squamous Cell Carcinoma

The goal of this clinical trial is to learn if an experimental, personalized cancer vaccine called TMV vaccine is safe and to find the best dose to study in future trials. The study includes adults with head and neck squamous cell carcinoma that has come back in or near the same area after earlier treatment, and who are planning to have surgery to remove it. The study will also test the vaccine together with toripalimab-tpzi, an approved immunotherapy drug. The TMV vaccine is made from each participant's own tumor tissue. Small particles taken from the surface of the tumor cells have 2 immune-boosting proteins added to them, to help the immune system recognize and attack the cancer. The main questions it aims to answer are: * Is the TMV vaccine safe, and what medical problems do participants have after receiving it? * What is the best dose of the TMV vaccine to use in future studies? * Is the TMV vaccine safe when given together with toripalimab-tpzi before and after surgery? The study has 2 parts. In Part 1 (Phase 1a), participants will: * Have tumor tissue collected during their planned surgery, which is used to make their personal vaccine * Receive the vaccine as small injections into the skin every 2 weeks for 3 doses, starting after they recover from surgery * Visit the clinic about once a week for 8 weeks for checkups, blood tests, and safety monitoring * Have scans every 3 months and be followed for up to 3 years The first participants will receive the lowest dose. Later groups will receive higher doses only if the lower dose is found to be safe. In Part 2 (Phase 1b), participants whose tumors test positive for a marker called PD-L1 will: * Have a biopsy to collect tumor tissue for their personal vaccine * Before surgery, receive 2 doses of the vaccine and up to 2 doses of toripalimab-tpzi through a vein * After surgery, receive 1 more dose of the vaccine and continue toripalimab-tpzi every 3 weeks for up to 1 year * Have regular checkups, blood tests, and scans, and be followed for up to 3 years Researchers will also study blood and tumor samples to learn how the immune system responds to the vaccine.

Bacterial Decolonization to Prevent Severe Radiation Dermatitis in Head and Neck Squamous Cell Carcinoma

Radiation dermatitis is a common and potentially treatment-limiting toxicity of radiotherapy for head and neck cancers. Colonization with Staphylococcus aureus has been identified as a risk factor for clinically significant radiation dermatitis, and bacterial decolonization has been shown to reduce moist desquamation in irradiated breast cancer patients. This randomized phase III trial evaluates whether a bacterial decolonization strategy can reduce the incidence of grade 2 radiation dermatitis with moist desquamation in patients receiving curative-intent radiotherapy (≥66 Gy) for cancers of the upper aerodigestive tract.

Window Trial of Intratumoral (IT) Neoadjuvant Fluorescently Labelled Nivolumab (nivo800) in Head and Neck Squamous Cell Carcinoma (HNSCC)

The goal of this clinical trial is to learn whether intratumoral (injected directly into the tumor) fluorescently labeled nivolumab (nivo800) is safe for adults with head and neck squamous cell carcinoma (HNSCC) who are scheduled to undergo surgery. Researchers also want to learn how well nivo800 travels to nearby lymph nodes and whether it can be used to study immune responses in and around the tumor. The main questions it aims to answer are: * Is intratumoral nivo800 safe and well tolerated in patients with HNSCC? * How much of the injected nivo800 reaches and remains in nearby lymph nodes, and how is drug delivery related to immune and tumor responses? Participants will: * Receive a first injection of nivo800 directly into the tumor approximately 14-21 days before surgery. * Receive a second injection of nivo800 directly into the tumor approximately 1-3 days before surgery. * Have physical exams, vital signs assessments, blood tests, and safety monitoring during the study. * Undergo their planned standard-of-care surgery, during which tumor and lymph node tissues will be collected for research analyses. * Provide blood samples and complete follow-up assessments to evaluate side effects and study drug distribution.

A Clinical Study on Neoadjuvant Treatment of Resectable Head and Neck Squamous Carcinoma With Immune-targeted Therapy and Lysogenic HSV Virus

Evaluation of the safety and tolerability of immune-targeted therapy combined with neoadjuvant therapy with lysogenic HSV virus for patients with surgically resectable squamous carcinoma of the head and neck.

MTX-531-001 Phase 1 Study in Advanced Solid Tumors

This is a first-in-human, Phase 1, open-label study evaluating MTX-531, an investigational dual EGFR/PI3K inhibitor, in adults with advanced solid tumors. The study will evaluate the safety and tolerability of MTX-531, determine the maximum tolerated dose and recommended Phase 2 dose, and assess how the drug is processed by the body and its preliminary anti-tumor activity.

A Phase 1 Study of EPI-326 in EGFR-mutant NSCLC and HNSCC

A phase 1 study to determine the safety, tolerability, PK, PD, and preliminary anti-tumor activity of ascending doses of EPI-326 administered to patients with locally advanced or metastatic HNSCC and to patients with any documented EGFR-mutant locally advanced or metastatic NSCLC.

Trial Evaluating the Tolerance and Safety of Durvalumab - RT Combination for Treatment in SCCHN

This study evaluate the regional (neck) nodal control of durvalumab in combination with RT restricted to the primary tumor and the immediately adjacent nodal level (i.e. without prophylactic neck irradiation) in N0 patients with SCCHN.

Randomized Trial of Avelumab-cetuximab-radiotherapy Versus SOCs in LA SCCHN (REACH)

The purpose of this study is to demonstrate that treatment with avelumab in combination with RT-cetuximab is superior to standard of care (SOC) cisplatin-RT and/or to SOC RT-cetuximab alone in terms of progression-free survival (PFS) in front-line patients with locally advanced SCCHN.

Pembrolizumab Combined With Cetuximab for Treatment of Recurrent/Metastatic Head & Neck Squamous Cell Carcinoma

This is a prospective, multi-center, open-label, non-randomized, multi-arm phase II trial to evaluate the efficacy of combination therapy with pembrolizumab and cetuximab for patients with recurrent/metastatic HNSCC. There will be four patient cohorts, including a PD-1/PD-L1 inhibitor-naïve, cetuximab-naïve arm (Cohort 1), a PD-1/PD-L1 inhibitor-refractory, cetuximab-naïve arm (Cohort 2), a PD-1/PD-L1 inhibitor-refractory, cetuximab-refractory arm (Cohort 3), and a cutaneous HNSCC arm (Cohort 4). A total of 83 patients (33 in Cohort 1, 25 in Cohort 2, 15 in Cohort 3, and 10 in Cohort 4) will be eligible to enroll. Patients will be enrolled at 4 sites: UC San Diego Moores Cancer Center, UC Los Angeles Jonsson Comprehensive Cancer Center, University of Michigan Comprehensive Cancer Center, and University of Washington Siteman Cancer Center.

A Phase 1, First-in-Human (FIH), Open-Label, Dose-Escalation and Dose Expansion Study of the Peptide Drug Conjugate (PDC), TS-104, as a Monotherapy in Subjects With Select Advanced Solid Tumors

A Phase 1, First-in-Human (FIH), Open-Label, Dose-Escalation and Dose Expansion Study of the Peptide Drug Conjugate (PDC), TS-104, as a Monotherapy in Subjects with Select Advanced Solid Tumors. The main goals of this study are to: * Find the recommended dose of TS-104 that can safely be given to participants * Learn more about the side effects of TS-104 * Learn more about the effectiveness of TS-104 * Learn more about the pharmacokinetics of TS-104

A First in Human Study of ALX2004 With Advanced or Metastatic Selected Solid Tumors

A Phase 1, First in Human, Open-Label Multicenter Study to Evaluate ALX2004, an Antibody Drug Conjugate Targeting EGFR in Participants with Advanced or Metastatic Select Solid Tumors

Intratumoral Delivery of Viral Replicon (saRNA) Particles Expressing IL-12 in Head and Neck Cancer

The goal of this clinical trial is to assess the safety and tolerability of a virus replicon particle (VRP) encapsulated saRNA encoding IL-12 when injected into in head and neck cancer patients. The main questions being addressed are: The safety and tolerability of intratumoral (IT) injections of VRP-encapsulated saRNA encoding IL-12 (VLPONC-01) The tumor response to IT injections of VLPONC-01 The tumor response due to the combination of IT injections of VLPONC-01 and system IV administration of neoadjuvant pembrolizumab (anti-PD-1) treatment Researchers will compare neoadjuvant pembrolizumab alone to the combination therapy to see if the combination enhances tumor responses.

First in Human Study of TUB-030 in Patients With Advanced Solid Tumors

The goal of this clinical trial is to learn if the drug TUB-030 works to treat solid cancer in adults. The study will also explore the safety of TUB-030. The main questions it aims to answer are: To determine the safety and tolerability of TUB-030 To determine the maximum tolerated dose of TUB-030 as a single drug given to patients with solid cancer Researchers will also compare doses of TUB-030 in two specific cancer types, in patients with head and neck cancer and patients with non-small cell lung cancer, to see if TUB-030 works to treat these two solid cancer types and to determine the best dose. Participants will: Receive drug TUB-030 every 3 weeks Visit the clinic once every 3 weeks for checkups and tests Answer patient reported outcome questionnaires about their symptoms

A Phase II Study to Evaluate the Efficacy and Safety of SKB571 in Recurrent or Metastatic HNSCC Participants

This is a multicenter, open-label, Phase II clinical study to assess the efficacy, safety, tolerability, PK characteristics, and immunogenicity of SKB571 in participants with recurrent or metastatic HNSCC.

ADCE-T02, a Tissue Factor Targeted Antibody-Drug Conjugate, in Patients With Selected Advanced Solid Tumours

Adcendo ApS is conducting a phase 1 study of an investigational drug called ADCE-T02 (previously known as AMT-754), a tissue factor targeted antibody-drug conjugate which may be used in the future as a possible treatment for advanced solid tumors. The main purpose of the study is to determine the Maximum Tolerated Dose (MTD), the recommended dose and the safety and tolerability of ADCE-T02 when given as a single therapy over a range of different dose levels. The expansion phase is now open for enrollment in indications including HNSCC and PDAC.

Combination Trial of Tipifarnib and Alpelisib in Adult Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)

This phase 1/2 combination trial of tipifarnib, a farnesyltransferase inhibitor, and alpelisib, a PI3K inhibitor in participants with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) whose tumors overexpress the HRAS protein and/or are PIK3CA-mutated and/or PIK3CA-amplified.

Induction Chemoimmunotherapy Followed by Deescalated Definitive Radiotherapy in Head and Neck Cancer

This study aims to evaluate whether reducing the intensity of radiotherapy (de-escalated radiotherapy) after induction chemoimmunotherapy is not inferior to standard-dose radiotherapy in patients with locally advanced head and neck squamous cell carcinoma (HNSCC). The study is a multicenter, prospective, phase II, randomized, non-inferiority controlled trial. A total of 180 participants who achieve deep tumor response (≥50% regression) after 2-3 cycles of induction chemotherapy plus PD-1 inhibitor (camrelizumab) will be randomized 1:1 to receive either de-escalated radiotherapy (experimental group) or standard radiotherapy (control group). Additional maintenance camrelizumab for 8 cycles after radiotherapy will be administered for both groups. The primary outcome is 2-year progression-free survival (PFS). Secondary outcomes include overall survival, local-regional control, distant metastasis-free survival, treatment-related adverse events, and quality of life. The study is expected to start in June 2026 and complete in December 2031.

Safety and Efficacy of VB10.16 and Pembrolizumab in Patients With Head-Neck Squamous Cell Carcinoma

This is a multi-center study in patients with un-resectable Recurrent or Metastatic HPV16-positive oropharyngeal Head and Neck Squamous Cell Carcinoma (HNSCC). The trial is designed to investigate VB10.16, an investigational therapeutic DNA vaccine in combination with another medicine, pembrolizumab, which is the standard of care for patients with previously untreated metastatic or resectable recurrent PD-L1 positive HNSCC. The study is divided in 2 parts: * Phase 1: Dose escalation to evaluate safety and determine the recommended phase 2 dose (RP2D) of VB10.16 * Phase 2: Randomized comparison of VB10.16 in combination with pembrolizumab versus pembrolizumab monotherapy The goal of Phase 1 is to evaluate the safety and tolerability of the combined treatment and to decide on the dose of VB10.16 to be used in the second part of the trial. The randomized Phase 2 will consist of 2 parallel arms exploring VB10.16 at the selected RP2D from the escalation phase in combination with pembrolizumab SoC (experimental arm, Arm A), versus pembrolizumab alone (control arm, Arm B).

Adebrelimab Combined With Dalpiciclib Isethionate Plus Chemotherapy for Neoadjuvant Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma

This single-center, open-label Phase II trial aims to evaluate the efficacy and safety of neoadjuvant combination therapy with Adebrelimab (anti-PD-L1), Dalpiciclib Isethionate (CDK4/6 inhibitor), and cisplatin chemotherapy in patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC). A total of 32 eligible subjects will receive 2 cycles of triplet neoadjuvant treatment prior to radical surgery. The primary endpoint is the pathological complete response (pCR) rate following neoadjuvant therapy; secondary endpoints include major pathological response (MPR), objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), 1-year overall survival (1y-OS), and treatment-related adverse events (TRAEs). The exploratory objectives analyze correlations between biomarkers (oral microbiome, CDKN2A/B deletion, CDK4/6 amplification, and PD-L1 expression) and therapeutic efficacy or prognosis. Subjects will receive long-term tumor and survival follow-up after surgery until disease progression, death, loss to follow-up, or the end of study.