Clinical Trials for Head And Neck Cancer

A First in Human Phase I Trial of Binary Oncolytic Adenovirus in Combination With HER2-Specific Autologous CAR T Cells in Patients With Advanced HER2 Positive 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.

TrialFetch AI summary: Eligible adult patients have advanced, refractory HER2-positive solid tumors with at least one injectable lesion. The trial evaluates safety and preliminary efficacy of intratumoral CAdVEC, an oncolytic adenovirus expressing IL-12 and a PD-L1 blocker, alone or in combination with intravenous HER2-specific autologous CAR T cells at higher dose levels.

ClinicalTrials.gov ID: NCT03740256

A Phase 1a/1b Dose Escalation/Expansion Study of TTX-080, an HLA-G Antagonist, as Monotherapy and in Combination With Pembrolizumab, Cetuximab or FOLFIRI Plus Cetuximab in Patients With Advanced Solid Refractory/Resistant 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.

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 or metastatic solid tumors (including HNSCC, NSCLC, colorectal, TNBC, RCC, and acral melanoma) that are refractory or resistant to standard therapies, testing the investigational HLA-G antagonist monoclonal antibody TTX-080 alone or combined with pembrolizumab, cetuximab, or FOLFIRI plus cetuximab. Control arms include standard regimens for comparison in metastatic colorectal cancer.

ClinicalTrials.gov ID: NCT04485013

Phase 1/1B Study of DS-8201a in Combination With ATR Inhibition (AZD6738) in Advanced Solid Tumors With HER2 Expression (DASH Trial)

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.

TrialFetch AI summary: This trial enrolls adults with advanced or metastatic HER2-expressing solid tumors—particularly colorectal and gastroesophageal cancers after progression on standard therapy—and evaluates intravenous trastuzumab deruxtecan (a HER2-targeted antibody-drug conjugate) in combination with oral ceralasertib (a selective ATR kinase inhibitor targeting DNA damage response pathways).

ClinicalTrials.gov ID: NCT04704661

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.

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 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

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

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.

TrialFetch AI summary: Adults with advanced EGFR-driven solid tumors, with expansion in squamous histologies (cSCC post/PD-1-ineligible, first-line R/M HNSCC by CPS strata, ICI-naïve SCAC after 1–2 lines, and stage IV squamous NSCLC post 1 line), receive BCA101 (ficerafusp alfa) alone or with pembrolizumab. BCA101 is a bifunctional anti-EGFR/TGF-β “trap” antibody designed to inhibit EGFR and locally neutralize TGF-β1/3; requires measurable disease and mandatory biopsies, excludes prior anti–TGF-β and certain recent anti-EGFR exposure.

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

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.

TrialFetch AI summary: Adults with EGFR‑dependent advanced solid tumors—primarily mCRC (RAS/RAF WT, MSS; anti‑EGFR–naive for chemo combos or 3L+ without HER2 amp/oncogenic EGFR ECD mutations) and previously included HNSCC—receive petosemtamab, a bispecific anti‑EGFR/LGR5 IgG1 antibody given Q2W as monotherapy or combined with FOLFOX/FOLFIRI (and previously pembrolizumab in HNSCC). Suitable for ECOG 0–1 patients without uncontrolled CNS disease; aims to exploit EGFR blockade and LGR5‑targeted EGFR degradation with Fc effector function.

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

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.

TrialFetch AI summary: Adults with advanced unresectable/metastatic solid tumors lacking effective options receive TU2218 (oral dual ALK5/TGFBR1 and VEGFR2 inhibitor targeting TGF-β/VEGF-mediated immunosuppression) plus pembrolizumab; expansion cohorts include PD-(L)1–naïve or post-platinum HNSCC (PD-L1 CPS ≥1 for naïve), biliary tract cancer after standard therapy, and PD-(L)1–naïve pMMR/MSS colorectal cancer after ≥2 lines (excluding CRC with liver metastases). Suitable for ECOG 0–1; key exclusions include active CNS disease, significant cardiovascular disease, active autoimmune disease requiring systemic therapy, prior TGF-β inhibitors, prior PD-(L)1 in specified cohorts, and certain drug–drug interactions.

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

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.

TrialFetch AI summary: Adults with advanced/metastatic solid tumors requiring at least one injectable lesion (ECOG 0–1) receive intratumoral T3011—an engineered oncolytic HSV‑1 expressing IL‑12 and an anti‑PD‑1 antibody—either as monotherapy in melanoma, HNSCC post‑platinum/PD‑(L)1, sarcoma, or cSCC, or combined with IV pembrolizumab in previously treated metastatic NSCLC without EGFR/ALK alterations. Excludes patients with uninjectable disease, high‑risk injection sites, active autoimmune disease requiring immunosuppression, active HSV, significant cardiopulmonary disease, CNS metastases, or active viral infections.

ClinicalTrials.gov ID: NCT04370587