Clinical Trials for Head And Neck Cancer

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, 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 Phase 1 Dose-Finding and Dose-Expansion Study of KIVU-107 in Participants With 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: Adults with locally advanced or metastatic solid tumors refractory to standard therapy or without proven effective options receive KIVU-107, an investigational PTK7-directed antibody-drug conjugate carrying an exatecan/topoisomerase I inhibitor payload. The study includes dose escalation followed by expansion at the recommended dose, with eligibility requiring measurable disease, ECOG 0–1, and adequate organ function.

ClinicalTrials.gov ID: NCT07229313

An Open-Label, Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE034 in Adult Participants With Locally 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 ECOG 0–1 and measurable locally advanced/metastatic solid tumors co-expressing B7-H3 and PTK7, after progression/intolerance to prior therapy or lacking standard options, including NSCLC, ESCC, endometrial, ovarian, HNSCC, TNBC, colorectal, and CRPC. All participants receive IDE034, an investigational bispecific B7-H3/PTK7 antibody–drug conjugate with a topoisomerase I inhibitor payload, in dose-escalation and expansion cohorts.

ClinicalTrials.gov ID: NCT07503808

A Phase 1, Multicenter, Open-Label, Dose-Escalation Study to Assess Safety, Tolerability, and Efficacy of EXS74539 as Monotherapy in Participants With Select 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 ECOG 0–1 and measurable advanced selected solid tumors, including SCLC, extrapulmonary high-grade neuroendocrine/small-cell carcinomas, NSCLC, prostate, ovarian, renal, HNSCC, hepatic, gastric, and triple-negative breast cancers, after progression/relapse/intolerance to at least one standard systemic therapy. All patients receive dose-escalated oral EXS74539/REC-4539 monotherapy, a selective reversible LSD1/KDM1A epigenetic inhibitor, to define safety and MTD with preliminary efficacy assessment.

ClinicalTrials.gov ID: NCT07517198

A First-in-Human, Open-label, Multicenter, Phase 1 Study of EPI-326 in Patients With Epidermal Growth Factor Receptor-Mutant Non-small Cell Lung Cancer and Head and Neck Squamous Cell Carcinoma

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 locally advanced/metastatic EGFR-mutant NSCLC or head and neck squamous cell carcinoma receive dose-escalated single-agent EPI-326. EPI-326 is an investigational tissue-selective bispecific antibody that binds EGFR and ITGB6 to promote internalization and lysosomal degradation of wild-type and mutant EGFR.

ClinicalTrials.gov ID: NCT07462377

A Phase 1 Study to Investigate PF-08046033 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 metastatic or unresectable locally advanced NSCLC, esophageal squamous cell carcinoma, or cutaneous melanoma after standard therapy or 1–2 prior systemic regimens receive IV PF-08046033 in 21-day cycles. PF-08046033 is an investigational GPNMB-directed antibody-drug conjugate delivering auristatin S to GPNMB-expressing tumor cells, with dose escalation followed by tumor-specific expansion cohorts.

ClinicalTrials.gov ID: NCT07519655

Phase 1/2 With Expansion Cohorts in a Study of NEO-201 in Adults With Chemo-Resistant 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.

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 patients are adults with advanced NSCLC, head and neck squamous cell carcinoma, cervical cancer, or uterine carcinoma, whose tumors express the NEO-201 antigen and who have progressed after standard therapies. Treatment consists of NEO-201 (a monoclonal antibody targeting tumor-associated O-glycans and CEACAM5/1 pathway) in combination with pembrolizumab.

ClinicalTrials.gov ID: NCT03476681

A Phase 1a, Dose Escalation, Safety and Tolerability Study of NX-1607, a Casitas B-lineage Lymphoma Proto-oncogene (CBL-B) Inhibitor, in Adults With Advanced Malignancies, With Phase 1b Expansion in Select Tumor Types

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.

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 or diffuse large B-cell lymphoma who have exhausted standard therapies, evaluating the investigational oral CBL-B inhibitor NX-1607 (which enhances antitumor immunity by blocking a negative regulator of immune cell activation) as monotherapy or in combination with paclitaxel. Eligible tumor types include ovarian, gastric, head and neck, melanoma, NSCLC, prostate, mesothelioma, triple-negative breast, urothelial, cervical, microsatellite-stable colorectal cancer, and DLBCL/Richter transformation.

ClinicalTrials.gov ID: NCT05107674

A Phase 1/2, First-in-Human, Open-Label, Dose Escalation and Expansion Study of STAR0602, a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule, in Subjects with Unresectable, Locally Advanced, or Metastatic Solid Tumors That Are Antigen-rich (START-001)

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.

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 study enrolls adults with unresectable, locally advanced, or metastatic antigen-rich solid tumors—including TMB-H, MSI-H/dMMR, virally associated, metastatic colorectal, triple negative breast, platinum-resistant ovarian, metastatic castration-resistant prostate, and NSCLC—who lack standard treatment options. Patients receive STAR0602 (invikafusp alfa), a bifunctional bispecific antibody that selectively activates and expands Vβ6/Vβ10 T cell subsets to enhance antitumor immunity.

ClinicalTrials.gov ID: NCT05592626