Clinical Trials for Melanoma

A Phase 1/1b, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF6002 as a Monotherapy and in Combination With Nivolumab in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications

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.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

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 adult patients with advanced or metastatic solid tumors (including melanoma, lung, head and neck, urothelial, gastric, esophageal, cervical, hepatocellular, and other select cancers) who have exhausted or are not candidates for standard therapy may receive DF6002, a novel IL-12 Fc fusion protein designed to enhance anti-tumor immunity, as monotherapy or in combination with nivolumab. Both subcutaneous and intravenous DF6002 dosing routes are under investigation.

ClinicalTrials.gov ID: NCT04423029

A Phase 1/2, Open-label Study of PD-1 Knockout Tumor-infiltrating Lymphocytes (IOV-4001) in Participants With Unresectable or Metastatic Melanoma or Stage III or IV Non-small-cell Lung Cancer

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.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

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 unresectable or metastatic melanoma or advanced non-small-cell lung cancer who have progressed after at least anti-PD-1/PD-L1 therapy, using an autologous tumor-infiltrating lymphocyte product (IOV-4001) genetically edited to knock out PD-1 via TALEN technology, administered after lymphodepleting chemotherapy and followed by high-dose IL-2. PD-1 knockout aims to enhance TIL antitumor activity by reducing exhaustion.

ClinicalTrials.gov ID: NCT05361174

A Phase 1a, Dose Escalation, Safety and Tolerability Study of NX-1607, a Casitas B-lineage Lymphoma Proto-oncogene (CBL-B) Inhibitor, in Adults With Advanced Malignancies, With Phase 1b Expansion in Select Tumor Types

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.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

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 or metastatic solid tumors or diffuse large B-cell lymphoma who have exhausted standard therapies, evaluating the investigational oral CBL-B inhibitor NX-1607 (which enhances antitumor immunity by blocking a negative regulator of immune cell activation) as monotherapy or in combination with paclitaxel. Eligible tumor types include ovarian, gastric, head and neck, melanoma, NSCLC, prostate, mesothelioma, triple-negative breast, urothelial, cervical, microsatellite-stable colorectal cancer, and DLBCL/Richter transformation.

ClinicalTrials.gov ID: NCT05107674

A Phase 1/2, First-in-Human, Open-Label, Dose Escalation and Expansion Study of STAR0602, a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule, in Subjects with Unresectable, Locally Advanced, or Metastatic Solid Tumors That Are Antigen-rich (START-001)

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.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

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 study enrolls adults with unresectable, locally advanced, or metastatic antigen-rich solid tumors—including TMB-H, MSI-H/dMMR, virally associated, metastatic colorectal, triple negative breast, platinum-resistant ovarian, metastatic castration-resistant prostate, and NSCLC—who lack standard treatment options. Patients receive STAR0602 (invikafusp alfa), a bifunctional bispecific antibody that selectively activates and expands Vβ6/Vβ10 T cell subsets to enhance antitumor immunity.

ClinicalTrials.gov ID: NCT05592626

A Phase 1 Open-Label, First-in-human, Dose Escalation and Expansion Study to Determine the Safety, Tolerability, Dosimetry, Pharmacokinetics, and Preliminary Efficacy of 212Pb-DOTAM-GRPR1 in Adult Participants With Recurrent or Metastatic GRPR-expressing Tumors

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.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

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 recurrent or metastatic GRPR-expressing solid tumors (including mCRPC, HR+/HER2- breast, colorectal, cervical, melanoma, and NSCLC) who have progressed on at least two prior systemic therapies, and treats them with 212Pb-DOTAM-GRPR1, a radiolabeled peptide that targets the gastrin-releasing peptide receptor (GRPR) to deliver alpha particle radiation directly to tumor cells.

ClinicalTrials.gov ID: NCT05283330

Phase 1 Trial With GD2-SADA:177Lu-DOTA Drug Complex in Patients With Recurrent or Refractory Metastatic Solid Tumors Known to Express GD2, Including Small Cell Lung Cancer, High Risk Neuroblastoma, Sarcoma and Malignant Melanoma

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.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

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: Enrolling adults (≥18; ≥16 for high-risk neuroblastoma or sarcoma) with measurable, GD2-positive recurrent/metastatic solid tumors (e.g., SCLC, high-risk neuroblastoma, sarcomas, melanoma) with ECOG 0–1 and adequate organ function. Two-step pretargeted radioimmunotherapy: IV GD2-SADA bispecific fusion protein (targets GD2; self-assembling/disassembling to enhance tumor avidity and renal clearance) followed after a set interval by 177Lu-DOTA to deliver beta radiation to tumor-retained antibody; dose-escalation with repeat cycles allowed.

ClinicalTrials.gov ID: NCT05130255

A Phase Ia/Ib, Open Label, Multicenter, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Checkpoint Inhibitor in Patients With Locally Advanced or Metastatic Solid Tumors

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.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

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 incurable, locally advanced or metastatic solid tumors (e.g., NSCLC, HNSCC, melanoma, TNBC, GI, cervical, CRC, urothelial, clear cell RCC, HCC) receive RO7502175, an afucosylated anti-CCR8 IgG1 designed to deplete intratumoral Tregs via enhanced ADCC, as monotherapy or combined with PD-(L)1 inhibitors (atezolizumab or pembrolizumab). Eligible patients have ECOG 0–1, measurable disease, and no active infections, autoimmune disease, or untreated CNS metastases.

ClinicalTrials.gov ID: NCT05581004

A Phase 1 Open-Label, Dose-Escalation and Dose-Expansion Study to Investigate the Safety, Pharmacokinetics, and Anti-Tumor Activity of IACS-6274 as Monotherapy and in Combination in Patients With Advanced Solid Tumors

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.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

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, refractory solid tumors (ECOG 0–1) lacking standard options receive the oral GLS1 inhibitor IACS-6274 either as monotherapy or combined with bevacizumab plus weekly paclitaxel or with the AKT inhibitor capivasertib. Biomarker-enriched cohorts include platinum-resistant high-grade serous ovarian cancer with low ASNS and tumors (including NSCLC) harboring KEAP1/NFE2L2/STK11/NF1 or PI3K/AKT/PTEN pathway alterations.

ClinicalTrials.gov ID: NCT05039801

First in Human Phase I Study of 225Actinium-MTI-201 (225Ac-MTI-201) in Metastatic Uveal Melanoma

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.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

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 metastatic uveal melanoma after at least one prior systemic or liver-directed therapy (ECOG 0–1) receive a single IV dose of 225Ac-MTI-201, an MC1R-targeted peptide radioligand delivering alpha-particle radiation, in a dose-escalation design. Key exclusions include prior alpha therapy, significant immunodeficiency or uncontrolled comorbidities, substantial prior marrow irradiation, pregnancy, and untreated/unstable CNS metastases.

ClinicalTrials.gov ID: NCT05496686

MEL-212: A Phase I Proof-of-Concept Study of CBL0137 (Curaxin) Combined With Ipilimumab and Nivolumab Therapy in Locally Advanced or Metastatic Melanoma

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.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

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 measurable, biopsy-accessible stage III (macroscopic nodal) or stage IV melanoma, ECOG 0–1, and no prior PD‑1/PD‑L1 or CTLA‑4 therapy receive ipilimumab plus nivolumab combined with CBL0137, a non-genotoxic DNA intercalator that traps FACT to activate p53 and suppress NF‑κB/HSF1/MYC. Excludes active autoimmune disease or need for immunosuppression; serial biopsies and blood draws required.

ClinicalTrials.gov ID: NCT05498792