Clinical Trials for Head And Neck Cancer

A Phase 1, Open-label, Multi-center Study of the Safety, Tolerability, and Efficacy of IPH4502 as a Single Agent in 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.

HealthScout AI summary: This trial enrolls adults with unresectable, locally advanced or metastatic solid tumors expressing Nectin-4 who have progressed after or are ineligible for standard systemic therapy, excluding those with brain metastases or serious comorbidities. Patients receive IPH4502, a novel antibody-drug conjugate targeting Nectin-4 with an exatecan payload, administered as monotherapy.

ClinicalTrials.gov ID: NCT06781983

A Phase I/II, Dose-escalation and Dose-optimization Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of MT-4561 in Patients With Various Advanced Solid Tumors and to Evaluate Effect of MT-4561 on Pharmacokinetics of Oral Midazolam

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.

HealthScout AI summary: This trial enrolls adults with advanced solid tumors—including HNSCC, NSCLC, GI, GU, gynecologic, sarcoma, neuroendocrine, and NUT carcinoma—who have measurable disease and good performance status, to evaluate the intravenous BRD4 degrader MT-4561 administered weekly. MT-4561 is a novel agent targeting BRD4 for ubiquitin-mediated degradation and is being assessed primarily for safety and initial efficacy in this biomarker-unselected population.

ClinicalTrials.gov ID: NCT06943521

A Phase 1a/1b, Multicenter, Open-label, Dose Escalation/Expansion, Multiple-dose Study to Evaluate the Safety and Activity of DR-0202 in Patients With Locally Advanced or Metastatic, Relapsed or Refractory Carcinomas

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.

HealthScout AI summary: Enrolling adults with locally advanced or metastatic epithelial cancers (including multiple breast cancer subtypes, NSCLC, cervical, prostate, pancreatic, head and neck, endometrial, ovarian, gastric/GEJ, or urothelial carcinomas) who have progressed after ≥2 prior therapies and lack standard options, this study delivers IV DR-0202, a bispecific antibody targeting CLEC7A on myeloid cells and a tumor-associated antigen, aiming to activate myeloid-driven phagocytosis and antitumor immunity.

ClinicalTrials.gov ID: NCT06999187

NECTINIUM-2: A Phase 1b, 2 Part, Multicenter, Single Arm, Open Label Study to Evaluate the Safety and Efficacy of a Nectin-4 Radiopharmaceutical ([225Ac]Ac-AKY-1189) in Patients With Previously Treated 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.

HealthScout AI summary: This trial is enrolling adults with previously treated, locally advanced or metastatic solid tumors (including urothelial carcinoma and other Nectin-4–positive types) who have measurable disease and good performance status. Patients receive [225Ac]Ac-AKY-1189, an investigational Nectin-4–targeting radiopharmaceutical that delivers actinium-225 directly to tumor cells, in up to six cycles following Nectin-4 PET imaging confirmation.

ClinicalTrials.gov ID: NCT07020117

A Phase 1, Open-label Study of Oral BDTX-4933 in Patients With KRAS, BRAF and Other Select RAS/MAPK Mutation Positive Neoplasms

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.

HealthScout AI summary: This trial enrolls adults with advanced or metastatic solid tumors—such as NSCLC (KRAS non-G12C), melanoma (BRAF/NRAS), histiocytic neoplasms, thyroid carcinoma, colorectal carcinoma (BRAF Class II/III), or other BRAF-mutant tumors—who have exhausted standard therapies, to receive oral BDTX-4933, a brain-penetrant RAF/RAS clamp inhibitor targeting a range of RAS/MAPK pathway mutations. The study includes dose escalation and expansion phases to assess safety and preliminary efficacy.

ClinicalTrials.gov ID: NCT05786924

A Phase 1/2, Open-label, First-in-human Study of the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ETX-636, a Pan-mutant-selective PI3Kα Inhibitor, as Monotherapy and in Combination With Other Anticancer Therapies 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.

HealthScout AI summary: This trial enrolls adults with advanced solid tumors harboring activating PIK3CA mutations who have progressed after standard therapy, including a cohort specifically for HR+/HER2- advanced breast cancer with prior CDK4/6 inhibitor and anti-estrogen exposure. Patients receive ETX-636, an oral, mutant-selective PI3Kα inhibitor and degrader, either as monotherapy or combined with fulvestrant.

ClinicalTrials.gov ID: NCT06993844

A Phase 1 Dose-Escalation and Expansion Study of Intratumorally Administered ONM-501 Alone and in Combination With Cemiplimab in Patients With Advanced Solid Tumors and Lymphomas

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.

HealthScout AI summary: Eligible patients are adults with advanced, unresectable, or recurrent solid tumors or lymphomas that have progressed on standard therapy and have at least one injectable, measurable lesion; they will receive intratumoral ONM-501, a dual-activating STING agonist, either alone or in combination with intravenous cemiplimab, a PD-1 inhibitor. Key exclusions include active or untreated brain metastases, recent major surgery, and active autoimmune disease (for combination cohorts).

ClinicalTrials.gov ID: NCT06022029

GUARDIAN-101: A Phase 1 Dose Escalation and Expansion Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation

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.

HealthScout AI summary: Adult patients with advanced solid tumors that are HLA-A*02:01 positive and harbor the p53 R175H mutation (confirmed by testing) receive CLSP-1025, a bispecific T-cell engager targeting the p53 R175H mutant peptide on tumor cells, as monotherapy. Prior p53 R175H-directed therapy, germline p53 mutations, and several comorbidities are exclusion criteria.

ClinicalTrials.gov ID: NCT06778863

Phase 1 Study of X-PACT (X-ray Psoralen Activated Cancer Therapy) for Intra-tumoral Injection of Superficial Tumors in Patients With Advanced Head and Neck Cancer, Breast Cancer, Soft Tissue Sarcoma or Melanoma

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.

HealthScout AI summary: This trial enrolls adults with advanced, superficial, and injectable head and neck cancer, breast cancer, soft tissue sarcoma, or melanoma that has progressed on or is ineligible for standard therapy. Patients receive intra-tumoral X-PACT, a novel approach using methoxsalen and a phosphor device activated by local X-ray to induce tumor cell death.

ClinicalTrials.gov ID: NCT04389281

A Multicenter FIH Dose Escalation and Optimization Phase I/IIa Trial to Investigate Safety, Tolerability, PK, and Efficacy of the 5T4 ADC TUB-030 in Patients With Advanced Solid Tumors (5-STAR 1-01)

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.

HealthScout AI summary: This trial enrolls adults with advanced, measurable solid tumors (including NSCLC and head and neck squamous cell carcinoma), evaluating intravenous TUB-030, an antibody-drug conjugate targeting the 5T4 oncofetal antigen and delivering a topoisomerase I inhibitor, in patients with ECOG 0-1 and adequate organ function. Patients may have clinically stable brain metastases and must have completed prior therapies.

ClinicalTrials.gov ID: NCT06657222