Clinical Trials for Head And Neck Cancer

NECTINIUM-2: A Phase 1b, 2 Part, Multicenter, Single Arm, Open Label Study to Evaluate the Safety and Efficacy of a Nectin-4 Radiopharmaceutical ([225Ac]Ac-AKY-1189) in Patients With Previously Treated Locally Advanced or Metastatic Solid Tumors

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 previously treated, progressing locally advanced or metastatic urothelial cancer enter dose escalation; expansion enrolls patients with Nectin-4–positive solid tumors identified by [64Cu]Cu-AKY-1189 imaging. All receive up to six cycles of [225Ac]Ac-AKY-1189, a Nectin-4–targeted radiopharmaceutical that delivers actinium-225 to tumor cells.

ClinicalTrials.gov ID: NCT07020117

A Phase 1/2, Open-label, First-in-human Study of the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ETX-636, a Pan-mutant-selective PI3Kα Inhibitor, as Monotherapy and in Combination With Other Anticancer Therapies in Participants With Advanced Solid Tumors

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 PIK3CA-mutated, unresectable or metastatic solid tumors after at least one prior therapy receive oral ETX-636, an investigational mutant-selective PI3Kα inhibitor, as monotherapy. Patients with HR-positive, HER2-negative advanced breast cancer previously treated with a CDK4/6 inhibitor and anti-estrogen therapy may receive ETX-636 plus fulvestrant.

ClinicalTrials.gov ID: NCT06993844

GUARDIAN-101: A Phase 1 Dose Escalation and Expansion Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation

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 or metastatic TP53 R175H-mutant solid tumors who are HLA-A*02:01-positive and have exhausted standard options receive CLSP-1025 monotherapy. This investigational T-cell engager binds CD3 and an HLA-A*02:01-presented mutant p53 peptide to direct T-cell killing of tumor cells.

ClinicalTrials.gov ID: NCT06778863

Phase 1 Study of X-PACT (X-ray Psoralen Activated Cancer Therapy) for Intra-tumoral Injection of Superficial Tumors in Patients With Advanced Head and Neck Cancer, Breast Cancer, Soft Tissue Sarcoma or 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.

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, superficial, and injectable head and neck cancer, breast cancer, soft tissue sarcoma, or melanoma that has progressed on or is ineligible for standard therapy. Patients receive intra-tumoral X-PACT, a novel approach using methoxsalen and a phosphor device activated by local X-ray to induce tumor cell death.

ClinicalTrials.gov ID: NCT04389281

A Multicenter FIH Dose Escalation and Optimization Phase I/IIa Trial to Investigate Safety, Tolerability, PK, and Efficacy of the 5T4 ADC TUB-030 in Patients With Advanced Solid Tumors (5-STAR 1-01)

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, measurable solid tumors and ECOG performance status 0–1 receive intravenous TUB-030 every three weeks; dose-optimization cohorts are limited to NSCLC and HNSCC. TUB-030 is an investigational 5T4-targeting antibody–drug conjugate that delivers exatecan, a topoisomerase I inhibitor.

ClinicalTrials.gov ID: NCT06657222

A Phase 1 Dose-Escalation Study of SLV-154 in Subjects With Metastatic Solid Tumors

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 previously treated, progressive metastatic head and neck, lung, breast, cervical, endometrial, ovarian, urothelial, sarcoma, or thyroid cancer receive escalating intravenous doses of SLV-154. This investigational antibody–drug conjugate is designed to deliver a cytotoxic payload to tumor cells; its specific target and payload have not been disclosed.

ClinicalTrials.gov ID: NCT06771219

Phase 1 Dose Escalation Study of Systemically Administered IL13Ra2 Chimeric Antigen Receptor (CAR) T Cells After a Nonmyeloablative Conditioning Regimen in Patients With Metastatic Melanoma and Other 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.

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 metastatic melanoma (including prior brain metastases) or other relapsed/refractory, IL13Ralpha2-expressing solid tumors to receive lymphodepleting chemotherapy followed by systemic infusion of autologous CAR T cells targeting IL13Ralpha2, a tumor-associated antigen. Patients must have good performance status and tumors confirmed to express IL13Ralpha2 by immunohistochemistry.

ClinicalTrials.gov ID: NCT04119024

A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of TROP2-Directed Antibody-Drug Conjugate LCB84, as a Single Agent and in Combination With an Anti-PD-1 Ab, in Patients With Advanced Solid Tumors

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 advanced solid tumors refractory to standard therapy or lacking a standard option, and ECOG performance status 0–1, receive IV LCB84 alone or with an anti-PD-1 antibody; expansion cohorts focus on selected tumor types. LCB84 is a TROP2-directed antibody–drug conjugate that delivers the cytotoxic payload monomethyl auristatin E.

ClinicalTrials.gov ID: NCT05941507

A Phase I/IIa Image-Guided, Alpha-Particle Therapy Study of [203Pb]Pb-PSV359 and [212Pb]Pb-PSV359 in Patients With Solid Tumors That Are Known to be Fibroblast Activation Protein (FAP)-Positive

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 locally advanced or metastatic solid tumors that have progressed after standard therapy or lack a standard option are eligible if at least one lesion shows uptake on [203Pb]Pb-PSV359 SPECT/CT. The imaging agent selects patients for treatment with [212Pb]Pb-PSV359, a FAP-targeted peptide that delivers alpha-particle radiation.

ClinicalTrials.gov ID: NCT06710756

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

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 previously treated patients with unresectable locally advanced, recurrent, or metastatic NSCLC, head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, or left-sided colorectal cancer; prior treatment with a topoisomerase I inhibitor–payload ADC is excluded. All participants receive ALX2004, an investigational EGFR-targeting antibody–drug conjugate with a topoisomerase I inhibitor payload, at a dose determined by the study stage.

ClinicalTrials.gov ID: NCT07085091