Clinical Trials for Head And Neck Cancer

A Phase Ib Study to Evaluate Safety and Persistence of Ex Vivo Expanded Universal Donor NK Cells in Combination with IL-2 and TGFbeta Receptor I Inhibitor Vactosertib in Patients with Locally Advanced/metastatic Colorectal Cancer, Gastric/esophageal Cancer, and Relapsed/refractory Hematologic Malignancies

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 locally advanced/metastatic colorectal, gastric, or esophageal cancer, or relapsed/refractory hematologic malignancies who have progressed on standard therapies or are ineligible, and treats them with fludarabine/cyclophosphamide lymphodepletion followed by ex vivo expanded universal donor NK cell infusions combined with low-dose IL-2 and vactosertib, a TGFβ receptor I (ALK5) inhibitor designed to enhance NK cell activity by blocking TGFβ-mediated immunosuppression.

ClinicalTrials.gov ID: NCT05400122

A Phase I/II Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD6750, a CD8 Guided IL-2 Agent Alone and in Combination With Other Anti-cancer Agents in Participants With Select Advanced or Metastatic Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 select advanced/metastatic solid tumors after standard therapy (melanoma, cSCC, Merkel cell, NSCLC, HNSCC, gastric/GEJ, RCC, HGSOC, TNBC) receive AZD6750, an investigational CD8-guided IL-2 designed to preferentially activate CD8+ T cells; a separate module enrolls NSCLC (including 1L PD-L1 ≥1%) to receive AZD6750 plus rilvegostomig, a bispecific PD-1/TIGIT antibody. Key exclusions include uncontrolled CNS disease, active autoimmune disease, prior severe I/O toxicities, and in the NSCLC module prior anti-TIGIT or targetable driver-positive 1L disease.

ClinicalTrials.gov ID: NCT07115043

Phase I Trial of [212Pb]VMT-Alpha-NET in Metastatic or Inoperable Somatostatin-Receptor Positive Gastrointestinal Neuroendocrine Tumors, Pheochromocytoma/Paragangliomas, Small Cell Lung, Renal Cell, and Head and Neck Cancers

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 metastatic or inoperable somatostatin receptor–positive tumors (GI NETs, pheochromocytoma/paraganglioma, small cell lung, renal cell, and select head/neck cancers) confirmed by SSTR PET receive [212Pb]VMT-Alpha-NET, an SSTR2-targeted alpha-emitting radioligand (212Pb→212Bi) given IV every 8 weeks for up to 4 cycles, with an optional [203Pb] imaging/dosimetry lead-in. Excludes prior systemic radioligand therapy; allows treated/stable or asymptomatic CNS mets and requires adequate organ function.

ClinicalTrials.gov ID: NCT06479811

Phase I Randomized Open Label Trial Investigating Adoptive Transfer of CD39+CD103+CD8+ Tumor-isolated T Cells (AGX148) Alone or Combined With siRNA Modulation of PD-1 (AGX148/PH-762) in Patients With Advanced Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 unresectable/metastatic solid tumors (post–standard therapy; prior ICI required for melanoma/HNSCC) undergo tumor harvest for autologous CD39+CD103+ CD8+ TIL therapy after cyclophosphamide/fludarabine lymphodepletion and IL-2 support. Patients are randomized to standard enriched TILs (AGX148) or the same product with ex vivo PD‑1 knockdown via self‑delivering siRNA PH‑762 (AGX148/PH‑762) to enhance effector function and persistence, with varying durations of low‑dose IL‑2 post-infusion.

ClinicalTrials.gov ID: NCT05902520

A Phase 1b/2a Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of TU2218, an Oral TGFβR Serine/Threonine Kinase Inhibitor, Administered in Combination With Pembrolizumab in Patients With Advanced Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 unresectable/metastatic solid tumors lacking effective options receive TU2218 (oral dual ALK5/TGFBR1 and VEGFR2 inhibitor targeting TGF-β/VEGF-mediated immunosuppression) plus pembrolizumab; expansion cohorts include PD-(L)1–naïve or post-platinum HNSCC (PD-L1 CPS ≥1 for naïve), biliary tract cancer after standard therapy, and PD-(L)1–naïve pMMR/MSS colorectal cancer after ≥2 lines (excluding CRC with liver metastases). Suitable for ECOG 0–1; key exclusions include active CNS disease, significant cardiovascular disease, active autoimmune disease requiring systemic therapy, prior TGF-β inhibitors, prior PD-(L)1 in specified cohorts, and certain drug–drug interactions.

ClinicalTrials.gov ID: NCT05784688

A Phase 1/2 Immunotherapy Study of Evofosfamide in Combination with Zalifrelimab and Balstilimab in Patients with Advanced Solid Malignancies

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 metastatic CRPC, pancreatic cancer, or HPV-negative SCCHN lacking effective options receive triplet therapy with evofosfamide (hypoxia-activated DNA crosslinking prodrug) plus zalifrelimab (anti–CTLA-4) and balstilimab (anti–PD-1). Open-label dose-escalation followed by disease-specific expansions; key exclusions include significant prior immune toxicity, active autoimmune disease, QTc ≥470 msec/TdP risk, uncontrolled CNS disease/infections, and use of strong/moderate CYP3A4 modulators or QT-prolonging drugs.

ClinicalTrials.gov ID: NCT06782555

A Phase 1B/2, Open-label Study of Q702 in Combination With Intravenous Pembrolizumab in Patients With Selected Advanced Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 esophageal, gastric/GEJ, hepatocellular, or cervical cancers that have progressed on prior anti–PD‑1/PD‑L1 therapy receive oral Q702 (adrixetinib), a selective AXL/MER/CSF1R inhibitor aimed at reprogramming the tumor microenvironment, in combination with IV pembrolizumab. Open‑label dose‑escalation followed by tumor‑specific expansion; key eligibility includes RECIST‑measurable disease and ECOG 0–1.

ClinicalTrials.gov ID: NCT05438420

A Phase 1/2 Open-Label, Umbrella Platform Design Study of MK-2870 With Pembrolizumab (MK-3475) and Chemotherapy in Participants With 1L Locally Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, and Esophageal Adenocarcinoma): Substudy 06C

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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: First-line study in adults with HER2-negative (or not known positive) unresectable/metastatic gastric/GEJ/esophageal adenocarcinoma (ECOG 0–1) comparing pembrolizumab plus fluoropyrimidine/oxaliplatin chemotherapy versus the same backbone combined with sacituzumab tirumotecan (MK-2870), a TROP2-directed antibody–drug conjugate delivering a belotecan-derived topoisomerase I inhibitor. Safety lead-in determines RP2D, then randomized assessment of response, PFS, and OS.

ClinicalTrials.gov ID: NCT06469944

A Phase 1/2 Open-Label, Umbrella Platform Design Study to Evaluate the Safety and Efficacy of MK-2870 Plus Paclitaxel as the Second-Line Treatment of Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma: Substudy 06D

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 unresectable locally advanced or metastatic gastric/GEJ/esophageal adenocarcinoma after exactly one prior platinum/fluoropyrimidine regimen (HER2-negative or unknown) are randomized to sacituzumab tirumotecan (TROP2-directed ADC with a topoisomerase I payload) plus paclitaxel versus standard ramucirumab plus paclitaxel. Excludes squamous histology and patients with significant comorbidities (e.g., grade ≥2 neuropathy, ocular surface disease, active CNS mets, recent arterial events, prior VEGF/VEGFR therapy, or prior TROP2/topo I ADCs).

ClinicalTrials.gov ID: NCT06445972

A Phase 1B, Multicenter, Open-Label Study of the Safety and Efficacy of CHS-114 in Combination With Toripalimab With or Without Other Treatments in Participants With Advanced or Metastatic Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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 unresectable, advanced/metastatic gastric/GEJ/esophageal adenocarcinoma (HER2‑negative, MSS/pMMR) in the 2L setting and ESCC in 1L or 2L receive the anti‑CCR8 monoclonal antibody CHS‑114 (depletes intratumoral CCR8+ Tregs via enhanced ADCC/ADCP) plus the PD‑1 inhibitor toripalimab, with cisplatin/5‑FU added in 1L ESCC. Requires measurable disease and tissue; excludes active CNS metastases and prior anti‑CCR8.

ClinicalTrials.gov ID: NCT06657144