Clinical Trials for Melanoma

A First-in-Human, Multicenter, Open-Label, Phase 1 Dose-Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TAB004 as Monotherapy and in Combination With Toripalimabin Subjects With Advanced Solid Malignancies Including Lymphoma

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: The trial is enrolling adults with advanced, unresectable, or metastatic solid tumors, including lymphoma, who have progressed after prior treatments, to evaluate the safety and tolerability of TAB004, a monoclonal antibody targeting BTLA, as monotherapy and in combination with toripalimab, an anti-PD-1 antibody.

ClinicalTrials.gov ID: NCT04137900

A Multicenter Open-Label Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: The trial involves adult patients with advanced solid tumors harboring specific RAS mutations, including KRAS G12, who have progressed after standard therapies, evaluating the safety and tolerability of RMC-6236, an oral selective inhibitor targeting active RAS(ON) with a novel 'tri-complex' mechanism. This investigational drug shows promising early efficacy, especially in KRAS G12X-related pancreatic and non-small cell lung cancers.

ClinicalTrials.gov ID: NCT05379985

A Phase 1/2, Open-label, Dose-escalation, and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Therapeutic Activity of GI-101 As a Single Agent and in Combination with Pembrolizumab, Lenvatinib or Local Radiotherapy in Patients with Advanced or Metastatic Solid Tumors (Keynote B59)

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: This trial involves adult patients with advanced or metastatic solid tumors and evaluates the safety and therapeutic activity of GI-101, a bispecific fusion protein targeting CTLA-4 and the IL-2 pathway, as a single agent and in combination with pembrolizumab, lenvatinib, or radiotherapy.

ClinicalTrials.gov ID: NCT04977453

IL Believe: A Phase 1/2, Open-label, Dose Escalation and Dose Expansion Study to Investigate the Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab, TransCon TLR7/8 Agonist, or Other Anticancer Therapies, in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: This trial targets adult patients with locally advanced or metastatic solid tumor malignancies, evaluating the safety and tolerability of TransCon IL-2 β/γ, a long-acting IL-2Rβ/γ receptor-targeting prodrug, alone or in combination with pembrolizumab, TransCon TLR7/8 agonist, or other anticancer therapies.

ClinicalTrials.gov ID: NCT05081609

A Phase 1a/1b Study to Evaluate the Safety and Tolerability of STK-012 As a Single Agent and in Combination Therapy in Patients with Selected Advanced Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: This trial enrolls adults with advanced solid tumors—including specific expansion cohorts for RCC, NSCLC, and PD-L1-negative NSCLC—who have progressed after or cannot tolerate standard therapies or are treatment naïve for metastatic disease without actionable mutations. Patients receive STK-012, an engineered IL-2 partial agonist that selectively stimulates CD25+ T cells with reduced toxicity risk, as monotherapy or in combination with pembrolizumab, and in NSCLC, with pembrolizumab plus pemetrexed and carboplatin.

ClinicalTrials.gov ID: NCT05098132

A Phase 1/2, First-in-Human, Open Label, Dose Escalation and Expansion Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adult patients with unresectable locally advanced or metastatic solid tumors (including melanoma, renal cell carcinoma, or PD-L1-positive NSCLC) who have progressed after or are ineligible for standard therapies receive AU-007, a novel monoclonal antibody that redirects IL-2 activity toward effector T and NK cells by blocking IL-2Rα, as monotherapy or in combination with recombinant IL-2 and/or checkpoint inhibitors. Patients must have adequate organ function, resolved prior immunotherapy toxicity, and measurable or evaluable disease.

ClinicalTrials.gov ID: NCT05267626

A Multicenter Phase I/Ib Dose Escalation and Expansion Study of WTX-124 as Monotherapy and in Combination With Pembrolizumab in Patients With Selected Advanced or Metastatic Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Eligible patients are adults with advanced or metastatic renal cell carcinoma, melanoma, cutaneous squamous cell carcinoma, or PD-L1-positive non-small cell lung cancer who are relapsed/refractory to standard therapy or lack standard options, have ECOG 0/1, and meet organ function criteria; exclusions include prior IL-2, active autoimmune disease, and symptomatic brain metastases requiring steroids. Treatments include WTX-124, a conditionally activated IL-2 prodrug that targets the tumor microenvironment, as monotherapy or in combination with pembrolizumab (anti-PD-1).

ClinicalTrials.gov ID: NCT05479812

A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTI TUMOR ACTIVITY OF PF-07799933 (ARRY-440) AS A SINGLE AGENT AND IN COMBINATION THERAPY IN PARTICIPANTS 16 YEARS AND OLDER WITH ADVANCED SOLID TUMORS WITH BRAF ALTERATIONS

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: This trial enrolls patients aged 16 or older with advanced or metastatic solid tumors (including brain tumors) featuring Class I/V600, II, or III BRAF alterations who have progressed after standard therapies, testing the brain-penetrant selective pan-mutant BRAF inhibitor PF-07799933 (ARRY-440) as monotherapy or in combination with binimetinib or cetuximab.

ClinicalTrials.gov ID: NCT05355701

Phase II Randomized Controlled Trial of Biologically Guided Stereotactic Body Radiation Therapy in Oligoprogressive Non-Small Cell Lung Cancer, Melanoma, and Renal Cell Carcinoma

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with oligoprogressive NSCLC, melanoma, or renal cell carcinoma (1-5 progressing sites while on or after checkpoint inhibitor therapy) are randomized to receive either standard SBRT or a PET-guided, biologically adaptive SBRT approach that uses PET/CT to guide dose escalation to metabolically active tumor regions. All participants must have lesions suitable for SBRT and ECOG performance status ≤2.

ClinicalTrials.gov ID: NCT05830058

A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with advanced or metastatic solid tumors who have progressed on, or are not candidates for, standard therapies (including anti-PD-1 where appropriate) may be eligible for this trial of BMS-986340, an investigational anti-CCR8 monoclonal antibody targeting tumor-infiltrating regulatory T cells, given as monotherapy or in combination with nivolumab or docetaxel. Patients must have measurable disease, ECOG 0-1, and be able to undergo mandatory tumor biopsies.

ClinicalTrials.gov ID: NCT04895709