Clinical Trials for Head And Neck Cancer

A Phase 1/2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

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.

HealthScout AI summary: This trial enrolls adults (and selected adolescents) with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation, who have progressed after at least one prior therapy, to receive rezatapopt (PC14586)—a selective oral p53 reactivator targeting the Y220C mutant—as monotherapy. Patients must have ECOG 0-1 and measurable disease; cohorts include ovarian, lung, breast, endometrial, and other solid tumors, with KRAS wild-type status required for some.

ClinicalTrials.gov ID: NCT04585750

A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB598 Monotherapy and 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 solid tumors who have exhausted standard therapies, with an expansion cohort for untreated, HER2-negative, locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma. Patients receive AB598, an anti-CD39 monoclonal antibody designed to amplify anti-tumor immune responses, as monotherapy or in combination with the PD-1 inhibitor zimberelimab and FOLFOX chemotherapy.

ClinicalTrials.gov ID: NCT05891171

An Open-Label, Multicenter, Phase 1/1b Study of JANX008 in Subjects with Advanced or Metastatic 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.

HealthScout AI summary: This trial enrolls adults with advanced or metastatic EGFR-expressing solid tumors (including NSCLC, SCCHN, CRC, RCC, SCLC, PDAC, or TNBC) who have progressed on or are intolerant to standard therapies, to receive JANX008—a protease-activated bispecific antibody that redirects T cells (via CD3) to target tumor cells (via EGFR), aiming to reduce off-tumor toxicity.

ClinicalTrials.gov ID: NCT05783622

An Open-Label Phase 1a/1b Dose-Escalation and Expansion Study Investigating the Safety, Pharmacokinetics, Pharmacodynamics, and Activity of AB248 Alone or in Combination with Pembrolizumab in Adult Patients with Locally Advanced or 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.

HealthScout AI summary: This trial enrolls adults with incurable, locally advanced, or metastatic solid tumors (ECOG 0-1, measurable disease, no active CNS metastases), testing the investigational IL-2 pathway–targeting fusion protein etakafusp alfa (AB248) alone or with pembrolizumab. AB248 is designed to selectively activate CD8+ T cells to enhance anti-tumor immunity while minimizing toxicity.

ClinicalTrials.gov ID: NCT05653882

A Phase 1 Study of SGN-PDL1V in 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 metastatic or unresectable, PD-L1–expressing solid tumors (including NSCLC, HNSCC, esophageal SCC, TNBC, ovarian cancer, melanoma, and gastric cancer) who have failed or are ineligible for standard therapies. Patients receive either SGN-PDL1V, an antibody-drug conjugate targeting PD-L1 and delivering MMAE, or a combination of SGN-PDL1V plus pembrolizumab.

ClinicalTrials.gov ID: NCT05208762

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.

HealthScout 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.

HealthScout 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.

HealthScout 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.

HealthScout 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.

HealthScout 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