Clinical Trials for Head And Neck Cancer

A PHASE 1A/B OPEN-LABEL MASTER STUDY OF PF-07799544 AS A SINGLE-AGENT AND IN COMBINATION WITH OTHER TARGETED AGENTS 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: This trial enrolls adults with advanced or metastatic solid tumors, including primary brain tumors, who have exhausted standard therapies, with dedicated cohorts for BRAF-mutant melanoma and other BRAF-mutated solid tumors; patients receive PF-07799544, a novel oral brain-penetrant MEK inhibitor, alone or in combination with a pan-mutant BRAF inhibitor (PF-07799933) or encorafenib, depending on tumor type and molecular profile.

ClinicalTrials.gov ID: NCT05538130

A Phase 1, First-in-human, Multicentre, Open-label, Dose Escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced 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.

TrialFetch AI summary: This trial enrolls adults with advanced or metastatic solid tumors (including HNSCC, NSCLC, mCRC, and PDAC) who have progressed on or lack standard therapies, to evaluate [225Ac]-FPI-2068, an investigational targeted alpha-emitting radiopharmaceutical directed against EGFR and c-MET, with or without FPI-2053 (a bispecific EGFR/c-MET antibody), and includes [111In]-FPI-2107 for diagnostic imaging.

ClinicalTrials.gov ID: NCT06147037

An Open-Label Phase 1/2A Study of GV20-0251 Monotherapy and GV20-0251 in Combination With Pembrolizumab in Participants With Advanced and/or Refractory Solid Tumor Malignancies

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: This trial enrolls adults with advanced or refractory solid tumors—including specific cohorts for endometrial, head and neck squamous, melanoma, non-small cell lung, and pMMR/MSS colorectal cancers—who have failed standard therapies and have good performance status. Patients receive GV20-0251, a first-in-class anti-IGSF8 monoclonal antibody targeting a novel immune checkpoint, as monotherapy or combined with pembrolizumab.

ClinicalTrials.gov ID: NCT05669430

A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1311 in Subjects With Advanced/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: This trial enrolls adults with advanced or metastatic solid tumors—including SCLC, NSCLC, ESCC, CRPC, melanoma, HCC, cervical cancer, HNSCC, and select rare cancers—who have progressed after or are intolerant to standard therapies. Patients receive DB-1311, an anti-B7-H3 antibody-drug conjugate linked to a topoisomerase I inhibitor, administered intravenously every 3 weeks.

ClinicalTrials.gov ID: NCT05914116

Phase I/II Trial of Autologous Rapamycin-Resistant Th1/Tc1 (RAPA-201) Cell Therapy of PD-(L)1 Resistant 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 enrolls adults with advanced, metastatic, or unresectable melanoma, small cell or non-small cell lung cancer, or squamous cell head and neck cancer that is refractory to prior anti-PD-(L)1 therapy, and treats them with standard carboplatin/paclitaxel plus infusions of autologous rapamycin-resistant Th1/Tc1-polarized T cells (RAPA-201, designed to resist immunosuppression and checkpoint inhibition), with anti-PD1 maintenance (pembrolizumab) in selected cohorts. Eligible patients must have good performance status and adequate organ function for apheresis.

ClinicalTrials.gov ID: NCT05144698

A Phase 1/2 Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ARV-806 in Participants With KRAS G12D Mutated 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: This trial enrolls adults with advanced solid tumors or pancreatic ductal adenocarcinoma harboring a KRAS G12D mutation who have received prior standard therapies, testing ARV-806, an investigational IV protein degrader specifically targeting mutant KRAS G12D. Patients with prior KRAS G12D/pan-KRAS inhibitor exposure or uncontrolled comorbidities are excluded.

ClinicalTrials.gov ID: NCT07023731

AN OPEN-LABEL PHASE 1 STUDY TO EVALUATE PF-08046037 AS MONOTHERAPY AND PART OF COMBINATION THERAPY IN PARTICIPANTS WITH ADVANCED MALIGNANCIES

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: This trial enrolls patients with advanced or metastatic NSCLC, HNSCC, melanoma, or PDAC to receive PF-08046037, an immune-stimulating antibody-drug conjugate targeting PD-L1 and delivering a TLR7 agonist, either as monotherapy or in combination with sasanlimab (anti-PD-1). Participants must have measurable disease and available tumor tissue, with other eligibility based on prior therapies and comorbidities.

ClinicalTrials.gov ID: NCT06974734

A Phase 1 Open-Label Study to Evaluate the Efficacy and Safety of ABBV-400 in Select Advanced Solid Tumor Indications

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: This trial enrolls adults with select locally advanced or metastatic solid tumors—including hepatocellular, pancreatic, biliary tract, esophageal, breast, head and neck, and certain gynecologic cancers—who have measurable disease and adequate organ function. Patients receive intravenous ABBV-400, an antibody-drug conjugate targeting c-Met and delivering a topoisomerase 1 inhibitor, as monotherapy.

ClinicalTrials.gov ID: NCT06084481

A Study to Evaluate the Safety and Tolerability of the Covalent Phosphoinositide-3-Kinase (PI3K)-Alpha Inhibitor, TOS-358, in Adult Subjects With Select 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: This trial enrolls adults with advanced or metastatic HR+/HER2- breast cancer, squamous head and neck, urothelial, or endometrial cancers harboring PIK3CA mutations or amplifications, who have not previously received PI3K, AKT, or mTOR inhibitors. Patients receive TOS-358, a first-in-class, covalent, and selective PI3Kα inhibitor, administered orally as a single agent.

ClinicalTrials.gov ID: NCT05683418

First-in-Human Study of STX-478, a Mutant-Selective PI3Kα Inhibitor as Monotherapy and in Combination With Other Antineoplastic Agents 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: This trial is enrolling adults with advanced, unresectable, or metastatic solid tumors harboring PIK3CA (PI3Kα) mutations, including HR+ breast, gynecologic, endometrial, and head and neck cancers, to receive the investigational orally administered mutant-selective PI3Kα inhibitor STX-478 as monotherapy or in combination with standard endocrine and CDK4/6 inhibitors. Eligible patients must have ECOG 0-1 and adequate organ function; those with uncontrolled diabetes or symptomatic CNS metastases are excluded.

ClinicalTrials.gov ID: NCT05768139