Clinical Trials for Head And Neck Cancer

A Phase 1, Open-label Study to Evaluate Safety, Tolerability, and Pharmacokinetics of an Anti-LILRB2 / PD-L1 Bispecific Antibody SPX- 303 in Patients With 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: Adults with locally advanced/metastatic solid tumors (ECOG 0–1) who have progressed on prior therapy and lack standard options receive SPX‑303 monotherapy, a first‑in‑class bispecific antibody targeting LILRB2 (ILT4) on myeloid cells and PD‑L1, given IV every 3 weeks. Excludes active/unstable CNS disease and prior ILT2/ILT4/HLA‑G–targeted therapy; allows well-controlled HIV.

ClinicalTrials.gov ID: NCT06259552

A Phase Ib Open Label Randomised Clinical Trial to Evaluate Safety and Efficacy of BI 770371 in Combination With Pembrolizumab With or Without Cetuximab Compared With Pembrolizumab Monotherapy for the First-line Treatment of Patients With Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)

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: Adults with untreated recurrent/metastatic HNSCC (non‑nasopharyngeal) eligible for pembrolizumab are randomized to pembrolizumab alone versus pembrolizumab plus BI 770371 (anti‑SIRPα blocking the CD47–SIRPα “don’t‑eat‑me” axis) with or without cetuximab (anti‑EGFR). Prior definitive therapy is allowed if >6 months from progression; requires measurable disease and tumor tissue, and excludes prior PD‑(L)1 or SIRPα/CD47 agents and active brain metastases.

ClinicalTrials.gov ID: NCT06806852

Pilot Study of INCB081776 Together With Palliative Radiation and Anti-PD-1 Checkpoint Blockade With Pembrolizumab in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

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: Adults with recurrent/metastatic, incurable HNSCC requiring palliative RT and having two index lesions (one for RT, one for serial biopsy) receive pembrolizumab plus the investigational oral AXL/MerTK (TAM) inhibitor INCB081776, with RT delivered to one lesion excluded from efficacy assessments. Suitable for patients recovered from prior therapies, without autoimmune disease requiring immunosuppression or significant retinal disorders.

ClinicalTrials.gov ID: NCT06308913

An Open-Label, Multicenter, Phase 1/1b Study of RNDO-564 as Monotherapy and in Combination With Pembrolizumab in Adult Participants With Relapsed/Refractory Locally Advanced or Metastatic Urothelial Cancer and Other Solid Tumors Associated With Nectin-4 Expression

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: Adults with incurable, locally advanced/metastatic Nectin-4–positive solid tumors—emphasizing relapsed/refractory urothelial cancer—receive RNDO-564 weekly as monotherapy or combined with pembrolizumab every 3 weeks. RNDO-564 is a fully human CD28 × Nectin-4 costimulatory bispecific antibody intended to deliver localized CD28 T‑cell costimulation at Nectin-4–expressing tumors; early cohorts include multiple Nectin-4–associated cancers, with randomized dose-optimization in urothelial cancer.

ClinicalTrials.gov ID: NCT07218003

A Phase 1 Dose-Escalation and Expansion Study Evaluating the Safety, Efficacy, and Pharmacokinetics of EVOLVE104 in Subjects With Advanced Urothelial and Squamous Cell 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: Adults with advanced/metastatic urothelial carcinoma or squamous cell carcinomas (lung, esophagus, cutaneous, head/neck, anogenital) after standard therapies receive single‑agent EVOLVE104, a trispecific T‑cell engager targeting ULBP2/5/6 with CD3 binding and CD2 costimulation. Open‑label dose escalation and expansion assess safety, PK, and preliminary efficacy, with treatment continued until progression or intolerance.

ClinicalTrials.gov ID: NCT07217171

A Multi-Center, Open Label, Phase 1/2 Study of CP-383, in Patients With 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: Adults with advanced/metastatic solid tumors lacking effective standard options (broad basket with prioritized cohorts such as CRC, SCLC, HNSCC, NSCLC, pancreatic, and bladder; some genomically enriched) receive oral single‑agent CP-383 in dose escalation and tumor‑specific expansions. CP-383 is a first‑in‑class small molecule designed to modulate lipid‑binding pockets on oncogenic proteins (exact target undisclosed).

ClinicalTrials.gov ID: NCT07030257

A Phase 1 Open-label Study to Investigate PF-08046876 in Adult 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: Adults with advanced/metastatic urothelial/bladder cancer, NSCLC, HNSCC, esophageal cancer, or pancreatic adenocarcinoma (ECOG 0–1) receive PF-08046876, an ITGB6-targeted antibody–drug conjugate delivering a topoisomerase I payload, as IV monotherapy after prior standard therapy (≤2 prior lines in Part 2). Dose escalation/optimization and tumor-specific expansions assess safety, PK, and preliminary activity; excludes prior camptothecin/topo I ADC exposure and significant GI or pulmonary comorbidities.

ClinicalTrials.gov ID: NCT07090499

A First-in-human, Phase I, Multi-center, Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Evidence of Antitumor Activity of IDOV-Immune in Adult 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: Adults with advanced solid tumors refractory to standard therapy (ECOG 0–1, measurable disease) receive a single intravenous infusion of IDOV-Immune (VM-002), a genetically engineered oncolytic vaccinia virus designed for tumor-selective replication and lysis with immune-stimulating transgenes to enhance antitumor immunity. Key exclusions include prior oncolytic virus therapy, recent vaccinia/smallpox vaccination, active autoimmune disease requiring systemic therapy, significant cardiopulmonary disease, uncontrolled infection, and unstable/untreated CNS metastases.

ClinicalTrials.gov ID: NCT06910657

A Dose Escalation and Dose Optimization Phase 1a/1b Study to Evaluate Safety, Tolerability and Dosimetry of Radioligand Therapy With LY4337713 in Adults With FAP-Positive Solid Tumors (FiREBOLT)

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: Adults with advanced/metastatic FAP-expressing solid tumors (including pancreatic, multiple breast cancer subtypes, platinum-resistant/refractory ovarian, and other FAP-positive GI tumors) and ECOG 0–1 receive intravenous LY4337713, a lutetium-177–labeled small-molecule radioligand targeting fibroblast activation protein on cancer-associated fibroblasts to deliver beta radiation to the tumor microenvironment, on Q4–6 week cycles. Expansion cohorts are tumor-specific after dose escalation/optimization.

ClinicalTrials.gov ID: NCT07213791

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.

HealthScout 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