Clinical Trials for Head And Neck Cancer

A Phase 1, First in Human, Open-Label Multicenter Study to Evaluate ALX2004, an Antibody Drug Conjugate Targeting EGFR in Participants With Advanced or Metastatic 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 previously treated, unresectable advanced/metastatic solid tumors (NSCLC, HNSCC, ESCC, left‑sided CRC) receive ALX2004 monotherapy, an investigational EGFR‑targeted antibody–drug conjugate carrying a topoisomerase I inhibitor payload designed for bystander effect. Excludes candidates for curative local therapy, rapidly progressive disease, short life expectancy, and prior exposure to topoisomerase I inhibitor ADCs.

ClinicalTrials.gov ID: NCT07085091

A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations

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 solid tumors harboring AKT/PI3K/PTEN pathway alterations (excluding concurrent EGFR/KRAS/NRAS/HRAS/BRAF drivers) receive the investigational AKT-pathway inhibitor TER-2013 as monotherapy (expansion in ovarian/cervical/SCCHN/lung/esophageal and endometrial cancers) or with fulvestrant for HR+/HER2- breast cancer previously treated with an aromatase inhibitor. Prior AKT/PI3K/PTEN inhibitors (and prior SERD/mTOR in combo expansion) are excluded; requires ECOG 0–1 and adequate organ function.

ClinicalTrials.gov ID: NCT07109726

An Open-label, Phase I/IIa First-in-human, Dose Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic and Antitumour Activity of ERK1/2 Inhibitor IPN01194 as Single Agent in Adult Participants With Advanced Solid Tumours

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 melanoma, colorectal cancer, pancreatic ductal adenocarcinoma, or head and neck squamous cell carcinoma harboring MAPK-pathway mutations and no suitable standard options receive oral IPN01194 monotherapy, an ERK1/2 (MAPK1/3) inhibitor targeting the terminal RAS–RAF–MEK–ERK pathway. Dose-escalation identifies two doses, followed by randomized expansion in a single tumor type to assess activity.

ClinicalTrials.gov ID: NCT06305247

A Phase I Dose-Escalation Trial of vvDD-hIL2-2-RG-1 (Vaccina Virus Double Deleted) Administered by Intra-tumoral (IT) Injection for Metastatic Gastrointestinal and Peritoneal 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 <70 with metastatic gastrointestinal or peritoneal tumors (esophageal, gastric, colorectal, liver, pancreatic) refractory to standard therapy, with at least one lesion amenable to intratumoral injection. Single intratumoral dose of vvDD-hIL2-2-RG-1, an oncolytic vaccinia virus (double-deleted TK/VGF) engineered to express membrane-tethered IL-2 to promote localized T-cell activation and oncolysis; no combination therapy in this first-in-human, single-dose escalation.

ClinicalTrials.gov ID: NCT07001592

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.

TrialFetch 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.

TrialFetch 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.

TrialFetch 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.

TrialFetch 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.

TrialFetch 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.

TrialFetch 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