Clinical Trials for Head And Neck Cancer

A Phase 1b/2 Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of Trastuzumab Deruxtecan (T-DXd) Monotherapy and Combinations in Adult Participants With HER2-expressing Gastric Cancer (DESTINY-Gastric-03)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

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 unresectable locally advanced or metastatic gastric, GEJ, or esophageal adenocarcinoma are eligible after progression on trastuzumab if HER2-positive, or in the first-line setting if HER2-positive or HER2-low, depending on the arm. Treatment includes trastuzumab deruxtecan, a HER2-directed antibody–drug conjugate delivering a topoisomerase I inhibitor, alone or with chemotherapy and/or checkpoint inhibitors, including the investigational PD-1/CTLA-4 bispecific volrustomig or PD-1/TIGIT bispecific rilvegostomig; one arm uses trastuzumab-based chemotherapy as a comparator.

ClinicalTrials.gov ID: NCT04379596

A Phase 2 Open-Label, Umbrella Platform Design Study of Investigational Agent(s) in Participants With 2L/3L Unresectable Locally Advanced or Metastatic Esophageal Cancer: KEYMAKER-U06 Substudy 06F

Active drug

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

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: This single-arm study enrolls patients with measurable, unresectable locally advanced or metastatic esophageal squamous cell carcinoma that has progressed after one or two prior systemic therapies for advanced disease. Participants receive ifinatamab deruxtecan, an investigational B7-H3–targeted antibody–drug conjugate that delivers a topoisomerase I inhibitor, every 3 weeks until progression or discontinuation.

ClinicalTrials.gov ID: NCT07405151

A Phase Ib/II Basket Study of BMS-986504 in Combination With Pemetrexed for Metastatic Solid Tumors With MTAP Deletion

Active drug

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

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 metastatic solid tumors harboring homozygous MTAP deletion who have progressed after at least one standard systemic regimen receive oral BMS-986504 plus intravenous pemetrexed. BMS-986504 is an investigational MTA-cooperative PRMT5 inhibitor designed to exploit MTAP-deletion–associated synthetic lethality.

ClinicalTrials.gov ID: NCT07594626

A Phase 1a/1b Study of LY4052031, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Advanced or Metastatic Urothelial Carcinoma or Other Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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: Patients with advanced or metastatic urothelial carcinoma after at least one prior regimen, including those previously treated with enfortumab vedotin, or selected other solid tumors after standard options are exhausted receive intravenous LY4052031. This investigational Nectin-4–targeted antibody–drug conjugate delivers a topoisomerase I inhibitor payload.

ClinicalTrials.gov ID: NCT06465069

A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors

Active drug

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

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.

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.

TrialFetch AI summary: Adults with measurable, locally advanced or metastatic solid tumors and ECOG performance status 0–1 receive MDNA11 alone or with pembrolizumab. MDNA11 is a long-acting IL-2 agonist designed to favor IL-2 receptor β signaling in CD8-positive T cells and natural killer cells while limiting regulatory T-cell stimulation; pembrolizumab blocks PD-1.

ClinicalTrials.gov ID: NCT05086692

A Dose-Escalation and Expansion Study of XB010 as a Single Agent and Combination Therapy in Subjects With Locally Advanced or Metastatic Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 inoperable locally advanced, metastatic, or recurrent solid tumors and no effective or tolerable standard options receive intravenous XB010, a 5T4-targeted antibody–drug conjugate carrying the microtubule-disrupting payload monomethyl auristatin E. Dose escalation evaluates XB010 alone or with pembrolizumab; tumor-specific expansion cohorts evaluate XB010 alone in NSCLC, breast, head and neck, esophageal, and endometrial cancers.

ClinicalTrials.gov ID: NCT06545331

A Seamless Phase 1/2 Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated Tmod™ CAR T, in Heterozygous HLA-A*02 Adults With Recurrent Unresectable, Locally Advanced, or Metastatic Solid Tumors That Express EGFR and Have Lost HLA-A*02 Expression

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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, recurrent unresectable, locally advanced, or metastatic EGFR-expressing solid tumors are eligible if they are germline HLA-A*02 heterozygous and their tumors have lost HLA-A*02 expression. After lymphodepleting chemotherapy, patients receive a single infusion of A2B395, an allogeneic CAR T-cell therapy designed to target EGFR-positive cells while sparing healthy cells that retain HLA-A*02.

ClinicalTrials.gov ID: NCT06682793

A Phase 1/2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

Active drug

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

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.

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.

TrialFetch AI summary: Patients with previously treated, locally advanced or metastatic TP53 Y220C–mutant solid tumors and ECOG performance status 0–1 may be eligible; the enrolling portion requires measurable disease and excludes tumors with a KRAS single-nucleotide variant. Participants receive oral rezatapopt, an investigational small molecule that stabilizes Y220C-mutant p53 to restore tumor-suppressor activity; earlier cohorts also evaluated rezatapopt with pembrolizumab.

ClinicalTrials.gov ID: NCT04585750

An Open-label, Phase 1 Dose Escalation and Phase 2 Dose Expansion Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SMP-3124LP in Adults With Advanced Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 solid tumors that have progressed after standard therapy receive IV SMP-3124LP, a PEGylated liposomal CHK1 inhibitor targeting the DNA-damage response. Dose escalation includes several tumor types; expansion focuses on platinum-resistant ovarian cancer, triple-negative breast cancer, and anal squamous cell carcinoma.

ClinicalTrials.gov ID: NCT06526819

A Phase 1/1b First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC026 in Participants With Advanced Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 relapsed or refractory, unresectable locally advanced or metastatic solid tumors, including metastatic castration-resistant prostate cancer, receive MGC026 intravenously every 21 days in dose-escalation or expansion cohorts. MGC026 is a B7-H3–targeting antibody–drug conjugate carrying an exatecan-based topoisomerase I inhibitor payload.

ClinicalTrials.gov ID: NCT06242470