Clinical Trials for Head And Neck Cancer

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

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.

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 advanced or metastatic non-CNS solid tumors and a BRCA1/2 or other specified homologous-recombination repair alteration receive the investigational oral PARG inhibitor IDE161 alone after progression on or intolerance to standard therapy. A separate cohort with recurrent or advanced endometrial cancer progressing after anti-PD-1/PD-L1 therapy receives IDE161 plus pembrolizumab.

ClinicalTrials.gov ID: NCT05787587

First-in-Human, Phase 1/1b, Open-label, Multicenter Study of Bifunctional EGFR/TGFβ Fusion Protein BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-Driven Advanced Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

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 advanced EGFR-driven solid tumors, including selected head and neck, anal, cutaneous, lung, and colorectal cancers, receive intravenous BCA101 alone or with pembrolizumab, depending on the cohort. BCA101 is a bifunctional anti-EGFR antibody fused to a TGF-β receptor domain that inhibits EGFR signaling and traps TGF-β.

ClinicalTrials.gov ID: NCT04429542

Locally ablatIVe thErapy for oLigo-progressive gastrOintestiNal maliGnancies (LIVELONG)

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.

TrialFetch AI summary: Adults with metastatic GI cancers (esophagus/GEJ/gastric, small bowel, colorectal/appendiceal, biliary, HCC, pancreatic/ampullary) on a benefiting systemic regimen who develop up to 5 new/progressing lesions receive lesion-directed local ablation (SABR or IR ablation) while continuing the same systemic therapy. Aims to control oligoprogression and delay systemic therapy change; excludes contraindications to ablation or active brain progression.

ClinicalTrials.gov ID: NCT06101277

Phase 1/2 Dose Escalation and Cohort Expansion Study Evaluating MCLA-158 (Petosemtamab) as Single Agent or in Combination in Advanced Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

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: Open cohorts enroll patients with unresectable or metastatic microsatellite-stable, RAS/RAF wild-type colorectal cancer and ECOG 0–1; combination cohorts require no prior anti-EGFR therapy. Patients receive petosemtamab, an investigational EGFR/LGR5-targeting bispecific antibody, alone or with pembrolizumab, FOLFIRI, or FOLFOX.

ClinicalTrials.gov ID: NCT03526835

A Phase 1b/2a Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of TU2218, an Oral TGFβR Serine/Threonine Kinase Inhibitor, Administered in Combination With Pembrolizumab in Patients With Advanced Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

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 solid tumors lacking an effective standard treatment option receive TU2218, an oral TGF-β receptor I (ALK5) and VEGFR2 inhibitor, plus pembrolizumab, an anti-PD-1 antibody. Tumor-specific cohorts focus on biliary tract cancer, head and neck squamous cell carcinoma, and mismatch repair–proficient/microsatellite-stable colorectal cancer without liver metastases.

ClinicalTrials.gov ID: NCT05784688

Sacituzumab Govitecan in Combination With Capecitabine for Advanced Gastrointestinal Cancers After Progression on Standard Therapy

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.

TrialFetch AI summary: Adults with metastatic GI adenocarcinomas (colorectal, pancreaticobiliary, or upper GI) progressing after standard therapy receive sacituzumab govitecan (Trop-2–targeted ADC delivering SN-38/topoisomerase I inhibitor) plus capecitabine in 21-day cycles; prior topo I inhibitor exposure is excluded, treated/stable brain mets allowed. Dose-escalation assesses safety/tolerability and seeks an RP2D, with exploratory correlation to tumor Trop-2 expression.

ClinicalTrials.gov ID: NCT06065371

A Phase 1/2a, Open-Label, Dose Escalation and Expansion Study of the Safety and Tolerability of T3011 Administered Via Intratumoral Injection as a Single Agent and in Combination With Intravenous Pembrolizumab in Patients With Advanced or Metastatic Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

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 advanced, recurrent, or metastatic solid tumors after standard therapy, an injectable tumor, and ECOG 0–1 receive intratumoral T3011 alone or with intravenous pembrolizumab; expansion cohorts include melanoma, head and neck or cutaneous squamous cell carcinoma, sarcoma, and EGFR/ALK-negative NSCLC. T3011 is an oncolytic HSV-1 engineered to lyse tumor cells and express IL-12 and an anti-PD-1 antibody fragment; pembrolizumab also blocks PD-1.

ClinicalTrials.gov ID: NCT04370587

Phase I Trial of CA-4948 in Combination With FOLFOX/PD-1 Inhibitor +/- Trastuzumab for Untreated Unresectable Gastric and Esophageal Cancer

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

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 previously untreated unresectable or metastatic gastric, gastroesophageal junction, or esophageal cancer and ECOG 0–1 receive mFOLFOX7 plus emavusertib (CA-4948), an investigational IRAK4/FLT3 inhibitor. HER2-negative patients also receive nivolumab; the HER2-positive expansion cohort receives trastuzumab and pembrolizumab.

ClinicalTrials.gov ID: NCT05187182

A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents With or Without Pembrolizumab (MK-3475) and/or Chemotherapy in Participants With Advanced Esophageal Cancer Previously Exposed to PD-1/PD-L1 Treatment (KEYMAKER-U06): Substudy 06B

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

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 locally advanced or metastatic esophageal squamous cell carcinoma progressing after one platinum- and PD-1/PD-L1–containing regimen receive investigator-selected paclitaxel or irinotecan, or investigational sacituzumab tirumotecan, a TROP2-directed antibody–drug conjugate delivering a topoisomerase I inhibitor. Arms combining pembrolizumab with the anti-ILT4 antibody MK-4830 and either chemotherapy or lenvatinib are no longer enrolling.

ClinicalTrials.gov ID: NCT05319730

Phase 1b/2a Study of RiMO-301 and Hypofractionated Radiotherapy With A PD-1 Inhibitor for the Treatment of Unresectable, Recurrent or Metastatic Head-Neck Cancer

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

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, recurrent or metastatic head and neck squamous cell carcinoma requiring palliative radiotherapy and eligible for pembrolizumab or nivolumab receive intratumoral RiMO-301, hypofractionated radiotherapy, and PD-1 blockade. RiMO-301 is an investigational hafnium-based metal–organic framework designed to enhance radiation effects in injected tumors.

ClinicalTrials.gov ID: NCT05838729