Clinical Trials for Head And Neck Cancer

A Phase 1, First-in-Human Study of the SMARCA2 Degrader, PLX-61639, in Patients With SMARCA4-Mutated Locally Advanced or Metastatic Solid Tumors

TrialFetch AI summary: Enrolls adults with relapsed/refractory locally advanced or metastatic solid tumors harboring a SMARCA4 loss-of-function mutation (ECOG 0–1, measurable disease) after progression on, intolerance of, or ineligibility for standard approved therapies. Patients receive oral once-daily PLX-61639, a SMARCA2 targeted protein degrader (synthetic-lethal strategy in SMARCA4-deficient tumors; DCAF16-linked, proteasome-mediated SMARCA2 degradation).

ClinicalTrials.gov ID: NCT07284186

A Phase I Study of Zanzalintinib With Pembrolizumab and Cetuximab in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck

TrialFetch AI summary: Enrolling adults with incurable recurrent/metastatic head and neck squamous cell carcinoma (ECOG 0–1, measurable disease), including previously untreated R/M disease only if PD-L1 CPS ≥1 or patients previously treated with anti–PD-(L)1 therapy (no PD-L1 restriction), excluding prior EGFR inhibitors/cetuximab or VEGFR-targeted therapy and >2 prior systemic lines in the R/M setting. Patients receive oral zanzalintinib (investigational multi-kinase TKI targeting VEGFR2, MET, and TAM kinases) daily plus pembrolizumab (anti–PD-1) and cetuximab (anti-EGFR) IV in 42-day cycles with dose escalation/expansion to define the RP2D.

ClinicalTrials.gov ID: NCT06912087

A Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE892 as Monotherapy and Combination Therapy in Participants With MTAP-Deleted Advanced Solid Tumors

TrialFetch AI summary: Adults with centrally confirmed MTAP homozygous loss/deletion and advanced solid tumors (ECOG 0–1) who have progressed after standard therapy are enrolled in dose escalation (mesothelioma, gastroesophageal, NSCLC, urothelial), with dose-expansion limited to MTAP-deleted NSCLC after platinum chemotherapy and PD-1/PD-L1 therapy (≤3 prior lines, prior appropriate targeted therapy if actionable). Participants receive IDE892, an MTA-cooperative PRMT5 inhibitor, as monotherapy or combined with IDE397, an oral MAT2A inhibitor, in 21-day cycles.

ClinicalTrials.gov ID: NCT07277413

A Phase 1/2a Study of the Safety, Tolerability, and Preliminary Clinical Activity of 177LuBetaBart, a 177Lu-Labeled Anti-B7-H3 Monoclonal Antibody, in Patients With Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors

TrialFetch AI summary: Enrolls adults with relapsed/refractory, locally advanced inoperable, or metastatic solid tumors (including CRPC, NSCLC/SCLC, CRC, HNSCC, ovarian/cervical/endometrial cancers, TNBC, and esophageal SCC) who have progressed after their most recent therapy and have no suitable standard option, with ECOG 0–2 and adequate organ function (measurable disease required except in CRPC; prior Lu-177–PSMA excluded for CRPC). Patients receive 177Lu-BetaBart, a lutetium-177–labeled anti–B7-H3 (CD276) monoclonal antibody delivering beta-particle radiation as systemic radioimmunotherapy in a dose-escalation/expansion design.

ClinicalTrials.gov ID: NCT07189871

A Phase 2 Multicenter, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Oral NRC-2694-A in Combination With Paclitaxel in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma, Who Progressed on or After Immune Checkpoint Inhibitor Therapy

TrialFetch AI summary: For adults with unresectable recurrent/metastatic HNSCC (oral cavity/oropharynx/hypopharynx/larynx) with measurable disease and ECOG 0–2 who have radiographic progression on/after prior immune checkpoint inhibitor therapy and no prior EGFR-targeted therapy or taxane for R/M disease. Treatment is oral NRC-2694-A (investigational EGFR tyrosine kinase inhibitor) 300 mg daily plus paclitaxel 175 mg/m² IV every 21 days (≥6 cycles per protocol).

ClinicalTrials.gov ID: NCT05283226

A Phase 1, Multicenter, Open-label, First-in-human, Dose Escalation and Expansion Study of DM005 in Patients With Advanced Solid Tumors

TrialFetch AI summary: Adults with metastatic/advanced NSCLC, gastroesophageal, colorectal, hepatocellular, pancreatic, or head and neck squamous cell carcinoma that has progressed on or is intolerant to standard systemic therapy (ECOG 0–2; measurable disease) receive DM005 (YH013) monotherapy IV Q3W. DM005 is a first-in-human bispecific antibody–drug conjugate targeting EGFR and c-MET, intended to preferentially bind EGFR/MET co-expressing tumors to enhance internalization and cytotoxic payload delivery, with dose escalation/expansion to define safety/MTD and assess preliminary activity.

ClinicalTrials.gov ID: NCT06515990

A Phase III, Multicentre, Randomised Controlled Study of Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in First-Line Claudin18.2-Positive, HER2-Negative, Advanced/Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (CLARITY-Gastric 02)

TrialFetch AI summary: Adults with previously untreated, unresectable locally advanced or metastatic CLDN18.2-positive, HER2-negative gastric/GEJ/distal esophageal adenocarcinoma (ECOG 0–1) are enrolled in PD-L1/ICI-eligibility–defined cohorts. Cohort 1 (PD-L1+ and ICI-eligible) tests the CLDN18.2-targeted ADC sonesitatug vedotin (CLDN18.2-directed, MMAE payload) plus capecitabine with rilvegostomig (PD-1/TIGIT bispecific) or with nivolumab versus standard nivolumab + CAPOX/FOLFOX, while Cohort 2 (PD-L1− or ICI-ineligible) compares sonesitatug vedotin + capecitabine versus zolbetuximab + CAPOX/FOLFOX.

ClinicalTrials.gov ID: NCT07431281

An Open-label Phase 1/2 Dose Finding, Safety and Efficacy Study of Oral NEO212 in Patients with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Uncontrolled Brain Metastasis in Patients with Select Solid Tumors.

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.

No known activity

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

TrialFetch AI summary: This clinical trial evaluates the safety and efficacy of the investigational drug NEO212, a novel conjugate of temozolomide and perillyl alcohol with enhanced brain penetration, in adults with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype, or uncontrolled brain metastases from select solid tumors, including combinations with standard treatments like pembrolizumab or ipilimumab.

ClinicalTrials.gov ID: NCT06047379

Open-label, Non-randomized, Multi-cohort, Phase 1b/2 Trial Investigating the Safety, Tolerability, and Antitumor Activity of STC-15 (a METTL3 Inhibitor) as a Part of Combination Therapy With Toripalimab in Participants With Selected Advanced Cancers

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 NSCLC, melanoma, endometrial cancer, or HNSCC who have progressed after standard therapies including prior anti-PD-1/L1 agents, and evaluates the combination of STC-15 (an oral METTL3 inhibitor targeting RNA methylation) plus toripalimab (anti-PD-1 antibody). Eligible patients must have measurable disease, ECOG 0–1, and no active CNS disease.

ClinicalTrials.gov ID: NCT06975293

A Randomized Trial Comparing Early Local Chemoradiation Therapy +/- Surgery Versus Systemic Therapy for Patients With Esophageal or Gastric Cancer With Oligometastases

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 esophageal or gastric adenocarcinoma and oligometastatic disease (≤3 lesions) who achieve disease control after 6–8 cycles of first-line fluoropyrimidine-based chemotherapy are randomized to continue systemic therapy versus add early local therapy with chemoradiation to primary/metastatic sites, with surgery permitted. Fluorouracil or capecitabine (antimetabolite thymidylate synthase inhibitors) are used in both arms; primary endpoint is overall survival.

ClinicalTrials.gov ID: NCT03161522