Clinical Trials for Head And Neck Cancer

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.

HealthScout 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.

HealthScout 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

An Open-Label Phase 1 Study to Evaluate PF-08046032 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.

HealthScout AI summary: This trial enrolls adults with advanced or metastatic malignancies—including relapsed/refractory Hodgkin lymphoma, certain non-Hodgkin lymphomas, and selected solid tumors—who meet specific prior treatment criteria, to receive PF-08046032, an investigational CD25-targeting antibody-drug conjugate designed to deplete tumor-infiltrating Tregs, as monotherapy or in combination with the anti-PD-1 antibody sasanlimab. Key exclusions are active autoimmune disease, significant prior immune toxicity, or ongoing neuropathy.

ClinicalTrials.gov ID: NCT06870487

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.

HealthScout 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.

HealthScout 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.

HealthScout 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

A Phase 1a/1b Multicenter, Open-label Dose Escalation/Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of PLN-101095 as Monotherapy and in Combination With Pembrolizumab in Adult Participants With Advanced or Metastatic Solid Tumors Who Have Disease Progression While on Pembrolizumab

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.

HealthScout AI summary: This trial enrolls adults with advanced or metastatic solid tumors that have progressed on at least three months of pembrolizumab, evaluating the investigational oral integrin αvβ8/αvβ1 inhibitor PLN-101095 as monotherapy or combined with pembrolizumab. Eligible patients must have no other effective treatment options and prior pembrolizumab resistance (primary or secondary).

ClinicalTrials.gov ID: NCT06270706

An Open-Label, Non-randomized, Multinational, Multi-center Phase I/Ⅱ Study Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Bi-Ligand-Drug Conjugate CBP-1019 in Patients 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.

HealthScout AI summary: This trial enrolls adults with advanced solid tumors (any histology) who have progressed on or are unsuitable for standard therapies and have measurable disease, regardless of tumor FRα or TRPV6 status. Patients receive IV CBP-1019, a bi-ligand-drug conjugate that targets Folate Receptor alpha and TRPV6 to deliver a topoisomerase I inhibitor directly to tumor cells.

ClinicalTrials.gov ID: NCT05830097

A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M07D1 in Subjects With HER2 Expressing Advanced Malignant 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.

HealthScout AI summary: Eligible patients are adults with advanced, HER2-expressing solid tumors (including gynecologic, urothelial, biliary tract, breast, lung, and gastrointestinal cancers) who have progressed after at least two prior lines of standard therapy. All participants receive BL-M07D1, an investigational HER2-directed antibody-drug conjugate that delivers a topoisomerase I inhibitor (Ed-04) selectively to tumor cells via IV infusion every 21 days.

ClinicalTrials.gov ID: NCT06293898

A Study of PARG Inhibitor IDE161 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.

HealthScout AI summary: This trial enrolls adults with advanced or metastatic solid tumors (excluding primary CNS tumors); for IDE161 monotherapy, patients must have BRCA1/2 or other homologous recombination deficiency gene alterations, while the combination arm is for patients with advanced or recurrent endometrial cancer who have progressed on prior anti–PD-1/L1 therapy. IDE161 is an investigational oral inhibitor of poly(ADP-ribose) glycohydrolase (PARG), targeting DNA repair in HR-deficient tumors, given alone or in combination with pembrolizumab.

ClinicalTrials.gov ID: NCT05787587