Clinical Trials for Head And Neck Cancer

A Phase 1, Open-Label Study of FT836, an Off-the-Shelf CAR T-Cell Therapy, With or Without Chemotherapy and/or Monoclonal Antibodies, in Participants With Advanced Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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: Adults with advanced, refractory solid tumors (ECOG 0–1) receive an allogeneic, off‑the‑shelf iPSC‑derived CAR T product (FT836) targeting stress‑inducible MICA/MICB (engineered to reduce antigen shedding) as monotherapy or combined with trastuzumab (HER2), cetuximab (EGFR), and/or paclitaxel. Multi‑arm cohorts assess safety and preliminary activity to establish RP2D for the combination regimens.

ClinicalTrials.gov ID: NCT07216105

A Phase 1/2 Open-label Multicenter Study to Assess the Safety, Pharmacokinetics, and Anti-tumor Activity of GTAEXS617 in Patients With Advanced Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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: Adults with advanced solid tumors including HNSCC, pancreatic adenocarcinoma, NSCLC, HR+/HER2− breast cancer post‑CDK4/6 inhibitor, or platinum‑resistant high‑grade serous ovarian/related cancers receive the oral CDK7 inhibitor GTAEXS617 (transcription/cell‑cycle regulator) as monotherapy or combined with standard-of-care regimens. Eligible patients have ECOG 0–1 and adequate organ function; study explores safety, PK, and preliminary activity with tumor biopsies required.

ClinicalTrials.gov ID: NCT05985655

A Phase I, First in Human (FIH), Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Preliminary Efficacy and Immunogenicity of TJ101 for Injection in Patients With Advanced/Metastatic Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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: Adults with advanced/metastatic solid tumors who have exhausted standard options receive IV TJ101, a bispecific EGFR/B7-H3 antibody–drug conjugate, every 3 weeks in dose escalation with biomarker-driven expansion cohorts. Excludes prior topoisomerase I inhibitor or TOP1i-ADC exposure, active ILD/pneumonitis, significant ocular or uncontrolled cardiovascular disease, and active CNS disease unless treated and stable.

ClinicalTrials.gov ID: NCT07181473

A Phase 1a/1b Study of NRM-823 as Monotherapy and in Combination With Immune Checkpoint Inhibition in Participants With Locally Advanced or Metastatic Refractory Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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: Adults with refractory locally advanced or metastatic solid tumors limited to NSCLC, TNBC, HNSCC, esophageal (SCC/adenocarcinoma), gastric/GEJ adenocarcinoma, and gynecologic (cervical/endometrial/ovarian) cancers (ECOG 0–1) receive NRM-823, a bispecific T‑cell engager targeting CD3 and a novel tumor antigen, as monotherapy with dose escalation/expansion, with a cohort combining NRM-823 plus an immune checkpoint inhibitor. Primary focus is safety and RP2D determination, with preliminary antitumor activity assessment.

ClinicalTrials.gov ID: NCT07182149

A Phase 1 Open-Label Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-Tumor Activity of STRO-004 in Adults With Refractory/Recurrent Metastatic Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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: Adults (ECOG 0–1) with refractory/recurrent locally advanced or metastatic solid tumors—particularly tissue factor–expressing cancers such as HNSCC, NSCLC, esophagogastric, colorectal, pancreatic ductal adenocarcinoma, cervical, endometrial, or urothelial carcinoma—after appropriate prior systemic therapy (prior-line limits vary by study part) are eligible. Treatment is STRO-004, a tissue factor–targeting antibody–drug conjugate delivering an exatecan (topoisomerase I inhibitor) payload, given as monotherapy with dose escalation/expansion or combined with pembrolizumab (PD-1 inhibitor).

ClinicalTrials.gov ID: NCT07227168

A First-In-Human Phase I, Open Label, Safety and Tolerability Study of Escalating Multiple Doses of Intratumoral MQ710, a Multi-Transgene Expressing Modified Vaccinia Virus Ankara-Based Virotherapy, Alone and in Combination With the Systemic Checkpoint Inhibitor Pembrolizumab in Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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: Enrolls adults with relapsed/refractory or treatment-ineligible advanced/metastatic solid tumors (ECOG 0–1) who have at least two injectable lesions, with emphasis on cutaneous and head/neck cancers (e.g., cSCC, BCC, melanoma, Merkel cell carcinoma, HNSCC) including anti–PD-1–refractory cohorts. Patients receive intratumoral MQ710/MQ719, a non-replicating modified vaccinia Ankara virotherapy (E5R-deleted to enhance cGAS/STING signaling and engineered to express Flt3L and OX40L), given in escalating multi-dose schedules alone or combined with systemic pembrolizumab (PD-1 inhibitor).

ClinicalTrials.gov ID: NCT05859074

A Phase 1, First-in-Human Study of the SMARCA2 Degrader, PLX-61639, in Patients With SMARCA4-Mutated Locally Advanced or Metastatic Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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: Enrolls adults with relapsed/refractory locally advanced or metastatic solid tumors harboring a SMARCA4 loss-of-function mutation (ECOG 0–1, measurable disease) after progression on, intolerance of, or ineligibility for standard approved therapies. Patients receive oral once-daily PLX-61639, a SMARCA2 targeted protein degrader (synthetic-lethal strategy in SMARCA4-deficient tumors; DCAF16-linked, proteasome-mediated SMARCA2 degradation).

ClinicalTrials.gov ID: NCT07284186

A Phase 1/2a Study of the Safety, Tolerability, and Preliminary Clinical Activity of 177LuBetaBart, a 177Lu-Labeled Anti-B7-H3 Monoclonal Antibody, in Patients With Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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: Enrolls adults with relapsed/refractory, locally advanced inoperable, or metastatic solid tumors (including CRPC, NSCLC/SCLC, CRC, HNSCC, ovarian/cervical/endometrial cancers, TNBC, and esophageal SCC) who have progressed after their most recent therapy and have no suitable standard option, with ECOG 0–2 and adequate organ function (measurable disease required except in CRPC; prior Lu-177–PSMA excluded for CRPC). Patients receive 177Lu-BetaBart, a lutetium-177–labeled anti–B7-H3 (CD276) monoclonal antibody delivering beta-particle radiation as systemic radioimmunotherapy in a dose-escalation/expansion design.

ClinicalTrials.gov ID: NCT07189871

A Phase 1, Multicenter, Open-label, First-in-human, Dose Escalation and Expansion Study of DM005 in Patients With Advanced Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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: Adults with metastatic/advanced NSCLC, gastroesophageal, colorectal, hepatocellular, pancreatic, or head and neck squamous cell carcinoma that has progressed on or is intolerant to standard systemic therapy (ECOG 0–2; measurable disease) receive DM005 (YH013) monotherapy IV Q3W. DM005 is a first-in-human bispecific antibody–drug conjugate targeting EGFR and c-MET, intended to preferentially bind EGFR/MET co-expressing tumors to enhance internalization and cytotoxic payload delivery, with dose escalation/expansion to define safety/MTD and assess preliminary activity.

ClinicalTrials.gov ID: NCT06515990

A First-In-Human Phase 1/2 Open-Label Study of Intravenous ST-067, Subcutaneous ST-067 with or Without Obinutuzumab Pre-Treatment, and ST-067 in Combination with Pembrolizumab in Subjects with Advanced Solid Malignancies

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.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 involves adult patients with advanced or metastatic solid tumors such as melanoma and non-small cell lung cancer who have relapsed after standard treatments, testing the investigational agent ST-067 alone or with pembrolizumab and obinutuzumab to enhance immune response against tumor cells.

ClinicalTrials.gov ID: NCT04787042