Clinical Trials for Head And Neck Cancer

A Phase 2/3, Randomized Study of INBRX-106 Combined With Pembrolizumab Versus Pembrolizumab as First Line Treatment for Patients With Recurrent or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) Expressing PD-L1 (CPS ≥20) (HexAgon-HN)

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.

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

HealthScout AI summary: Adults with PD-L1–high (CPS ≥20) recurrent or metastatic HNSCC (non-nasopharyngeal) and ECOG 0–1 are randomized to pembrolizumab alone versus pembrolizumab plus INBRX-106, a hexavalent OX40 (CD134) agonist antibody that enhances T‑cell costimulation. Prior systemic therapy for R/M disease is not allowed; key exclusions include active CNS metastases and significant autoimmune disease.

ClinicalTrials.gov ID: NCT06295731

Decentralized Pilot Study of Triple Oral Metronomic Chemotherapy for Patients With Recurrent/Metastatic Oral Cavity Cancer in a Rural Midwest United States Population

Low burden on patient

The trial has a low burden on patients. An example would be a trial testing an oral drug, with scans every 12 weeks which would be similar to standard of care.

HealthScout AI summary: Adults with recurrent/metastatic oral cavity cancer after or ineligible for standard first-line immunotherapy/chemo-immunotherapy (ECOG 0–2) receive a fully oral metronomic regimen of methotrexate (antifolate), erlotinib (EGFR TKI), and celecoxib (COX‑2 inhibitor) in 28‑day cycles, delivered with decentralized/virtual components. Excludes significant cardiac risk, active serious infection/bleeding, uncontrolled viral hepatitis/HIV, pregnancy, and concurrent investigational therapy.

ClinicalTrials.gov ID: NCT06997068

A Phase 2 Trial of Intraoperative Fluorescent Angiography to Decrease Pharyngocutaneous Fistula Rates in Patients Undergoing Hypopharyngeal Reconstruction

Low burden on patient

The trial has a low burden on patients. An example would be a trial testing an oral drug, with scans every 12 weeks which would be similar to standard of care.

HealthScout AI summary: Adults with previously irradiated stage II–IV laryngeal or hypopharyngeal squamous cell carcinoma undergoing salvage total laryngectomy receive intraoperative indocyanine green (ICG) fluorescence angiography with the SPY system to assess mucosal perfusion, with resection of hypoperfused tissue prior to reconstruction. ICG is a near-infrared fluorescent dye used for real-time perfusion imaging, aiming to reduce postoperative pharyngocutaneous fistula, particularly in intraoperatively defined high-risk cases.

ClinicalTrials.gov ID: NCT06831149

Phase I Study of MEM-288 Oncolytic Virus Alone and in Combination With Nivolumab in Solid Tumors Including Non-Small Cell Lung Cancer (NSCLC)

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.

HealthScout AI summary: This trial enrolls adult patients with advanced solid tumors, including NSCLC, who have progressed after anti-PD-1/PD-L1 therapy to evaluate MEM-288, an oncolytic adenovirus with immunostimulatory properties, alone and in combination with the PD-1 inhibitor nivolumab.

ClinicalTrials.gov ID: NCT05076760

A Phase 1/2, Open-label, Dose-escalation, and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Therapeutic Activity of GI-101 As a Single Agent and in Combination with Pembrolizumab, Lenvatinib or Local Radiotherapy in Patients with Advanced or Metastatic Solid Tumors (Keynote B59)

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.

HealthScout AI summary: This trial involves adult patients with advanced or metastatic solid tumors and evaluates the safety and therapeutic activity of GI-101, a bispecific fusion protein targeting CTLA-4 and the IL-2 pathway, as a single agent and in combination with pembrolizumab, lenvatinib, or radiotherapy.

ClinicalTrials.gov ID: NCT04977453

A Phase 1 First-Time-in-Human, Open-Label Study of GSK4381562 Administered as Monotherapy and in Combination With Anticancer Agents in Participants With Selected 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.

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.

HealthScout AI summary: This trial investigates GSK4381562, a monoclonal antibody targeting PVRIG to enhance NK and T cell activation, as monotherapy and in combination with anticancer agents such as dostarlimab, belrestotug, nelistotug, and GSK5764227 in patients with advanced solid tumors who lack standard treatment options. Eligible participants have locally recurrent or metastatic solid tumors, have progressed after standard therapies, and possess an ECOG performance status of 0-1 with adequate organ function.

ClinicalTrials.gov ID: NCT05277051

Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT5528 in Patients With Advanced Malignancies Associated With EphA2 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.

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.

HealthScout AI summary: This trial involves patients over 18 with advanced solid tumors expressing high levels of EphA2, testing the safety and efficacy of BT5528, a targeted Bicycle Toxin Conjugate linked to MMAE, as a monotherapy and in combination with the PD-1 inhibitor nivolumab, particularly in ovarian, urothelial, lung, breast, head and neck, and gastric cancers after progression on standard treatments.

ClinicalTrials.gov ID: NCT04180371

A Phase 1/2 Study of [225Ac]-FPI-1434 Injection in Patients With Locally Advanced or Metastatic Solid Tumours

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.

HealthScout AI summary: Eligible patients are adults with advanced, metastatic, or recurrent solid tumors (including endometrial, cervical, ovarian, triple-negative or HER2-negative breast, head and neck, adrenocortical, or uveal melanoma) that express IGF-1R and lack standard treatment options. Treatment involves [225Ac]-FPI-1434, a humanized anti-IGF-1R monoclonal antibody conjugated to the alpha-emitter actinium-225 for targeted alpha radioimmunotherapy, with optional use of unlabeled antibody (FPI-1175) to optimize safety and efficacy.

ClinicalTrials.gov ID: NCT03746431

A Phase 1a/1b Study to Evaluate the Safety and Tolerability of STK-012 As a Single Agent and in Combination Therapy in Patients with Selected 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.

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.

HealthScout AI summary: This trial enrolls adults with advanced solid tumors—including specific expansion cohorts for RCC, NSCLC, and PD-L1-negative NSCLC—who have progressed after or cannot tolerate standard therapies or are treatment naïve for metastatic disease without actionable mutations. Patients receive STK-012, an engineered IL-2 partial agonist that selectively stimulates CD25+ T cells with reduced toxicity risk, as monotherapy or in combination with pembrolizumab, and in NSCLC, with pembrolizumab plus pemetrexed and carboplatin.

ClinicalTrials.gov ID: NCT05098132

A Phase 1/1b/2 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 193 Alone and in Combination With Docetaxel in Subjects With Advanced MTAP-null 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.

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.

HealthScout AI summary: Adults with advanced or metastatic, histologically confirmed MTAP-null solid tumors—including NSCLC, BTC, HNSCC, pancreatic, esophageal/gastric cancers, and glioma—are eligible for treatment with AMG 193 (a selective, MTA-cooperative PRMT5 inhibitor exploiting synthetic lethality in MTAP-deleted tumors), either as monotherapy or combined with docetaxel.

ClinicalTrials.gov ID: NCT05094336