Clinical Trials for Head And Neck Cancer

Phase 1 / 2 Multicenter Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of APL-101 in Subjects With Non-Small Cell Lung Cancer With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors

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

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: The trial investigates APL-101, a selective c-MET receptor tyrosine kinase inhibitor, in adult patients with NSCLC exhibiting c-Met exon 14 skipping mutations, various solid tumors with MET alterations, and primary CNS tumors. It includes APL-101 monotherapy and combination therapy with EGFR inhibitors in cases of acquired MET amplification resistance.

ClinicalTrials.gov ID: NCT03175224

A Phase II Study of agenT-797 (Invariant Natural Killer T Cells), Botensilimab, a Novel Fc-enhanced CTLA-4 Inhibitor, Plus Balstilimab (Anti-PD-1) With Ramucirumab and Paclitaxel for Patients With Previously Treated, Advanced Esophageal, Gastric, or Gastro-esophageal Junction Adenocarcinoma

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

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/metastatic esophageal, gastric, or GEJ adenocarcinoma after one prior line (or relapse ≤6 months after perioperative therapy), ECOG 0–1, receive ramucirumab plus paclitaxel combined with investigational immunotherapies: agenT‑797 (allogeneic invariant NKT cell therapy targeting CD1d-presented glycolipids), botensilimab (Fc‑enhanced CTLA‑4 inhibitor), and balstilimab (PD‑1 inhibitor). Excludes prior ramucirumab, recent taxane, severe prior irAEs from PD‑(L)1/CTLA‑4, active CNS mets, significant neuropathy, or active viral infections.

ClinicalTrials.gov ID: NCT06251973

A Phase 3, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) (IDeate-Esophageal01)

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

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 or metastatic ESCC after exactly one prior platinum-based chemo plus immune checkpoint inhibitor are randomized to ifinatamab deruxtecan, a B7-H3–targeted antibody–drug conjugate delivering a topoisomerase I inhibitor, versus investigator’s choice of docetaxel, paclitaxel, or irinotecan. Key eligibility includes ECOG 0–1, measurable disease, and exclusion of prior B7‑H3 or topo I agents and significant ILD/pneumonitis or CNS disease.

ClinicalTrials.gov ID: NCT06644781

An Open-label Phase II/III Randomized Trial of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Monotherapy as a First Line Therapy in Patients With Unresectable Recurrent, or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) Which is Positive for Human Papilloma Virus 16 (HPV16+) and Expresses PD-L1

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

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 unresectable recurrent or metastatic HPV16-positive, PD-L1 CPS ≥1 HNSCC (non-nasopharyngeal), treatment-naïve in the R/M setting, are randomized to pembrolizumab alone versus pembrolizumab plus BNT113, an investigational HPV16 E6/E7 mRNA lipoplex vaccine designed to activate dendritic cells and elicit HPV16-specific T-cell responses. Requires measurable disease and available tumor tissue; prior systemic therapy for locally advanced disease allowed if completed >180 days before randomization.

ClinicalTrials.gov ID: NCT04534205

A Phase II Study of ACR-368 and Low Dose Gemcitabine Combination Therapy in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma

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

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 recurrent or metastatic HNSCC (oral cavity, oropharynx, larynx, hypopharynx, including p16/HPV+ unknown primary) after prior PD-1/PD-L1 therapy receive the CHK1/2 inhibitor ACR-368 (prexasertib) plus ultra–low-dose gemcitabine every 2 weeks, with separate cohorts by p16/HPV status. Requires measurable disease, ECOG 0–1, recent tissue for p16/HPV and OncoSignature, and biopsy willingness; key toxicities expected are transient high-grade myelosuppression.

ClinicalTrials.gov ID: NCT06597565

A Phase II, Multicenter, Open-Label Trial of DB-1311 in Combination With BNT327 or DB-1305 in Participants With Advanced/Metastatic Solid Tumors

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

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: Enrolls adults with advanced/metastatic solid tumors—HCC (Child-Pugh A), cervical, melanoma, recurrent/metastatic HNSCC, platinum‑resistant high‑grade serous ovarian, and nonsquamous NSCLC without actionable drivers—ECOG 0–1 and measurable disease. Investigational therapy pairs the B7‑H3–targeted topoisomerase‑I ADC DB‑1311 with either BNT327 (PD‑L1/VEGF‑A bispecific) for HCC/cervical/melanoma/HNSCC or with the TROP2‑directed topoisomerase‑I ADC DB‑1305 for NSCLC.

ClinicalTrials.gov ID: NCT06953089

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

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

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: 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 II Trial of T Cell Receptor Gene Therapy Targeting Human Papillomavirus ( HPV) 16 E7 for HPV-Associated Cancers

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

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.

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 metastatic or recurrent HPV16-positive cancers (e.g., cervical, oropharyngeal, anal, vulvar, vaginal, penile) who are HLA-A*02:01–positive receive lymphodepleting cyclophosphamide/fludarabine, a single infusion of autologous T cells engineered with a high-avidity TCR targeting HPV16 E7(11–19), followed by high-dose IL-2. Designed for patients post standard therapy or who declined it; controlled brain metastases allowed.

ClinicalTrials.gov ID: NCT05686226

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

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.

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 unresectable/metastatic HER2-expressing gastric/GEJ/esophageal adenocarcinoma (HER2-positive or HER2-low) receive trastuzumab deruxtecan (anti‑HER2 antibody–drug conjugate delivering a topoisomerase I inhibitor) as monotherapy or combined with fluoropyrimidines and/or checkpoint inhibitors (durvalumab, pembrolizumab, or investigational bispecifics volrustomig [PD‑1/CTLA‑4] and rilvegostomig [PD‑1/TIGIT]); first-line cohorts include a comparator of trastuzumab plus fluoropyrimidine/platinum. Prior trastuzumab exposure is required only for a post-trastuzumab cohort, with key exclusions including active ILD/pneumonitis and untreated CNS metastases.

ClinicalTrials.gov ID: NCT04379596

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: This trial evaluates MDNA11, an IL-2 Superkine targeting the IL-2 beta receptor to enhance anti-tumor immunity, administered alone or with pembrolizumab, in adult patients with locally advanced or metastatic solid tumors. Eligible patients must have an ECOG performance status of 0 or 1 and adequate organ function.

ClinicalTrials.gov ID: NCT05086692