Clinical Trials for Head And Neck Cancer

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

A Phase 1 Dose-Escalation Study of SLV-154 in Subjects With 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: Eligible patients are adults with metastatic squamous cell carcinoma of the head and neck, non-small cell or small cell lung cancer, breast, cervical, endometrial, ovarian, urothelial, sarcoma, or thyroid cancer that has progressed after standard therapies; participants must have measurable disease, adequate organ function, and be willing to undergo tumor biopsy. Patients will receive intravenous SLV-154 (mechanism and target undisclosed) in 3-week cycles at escalating doses to determine safety and dosing parameters.

ClinicalTrials.gov ID: NCT06771219

Phase 1 Dose Escalation Study of Systemically Administered IL13Ra2 Chimeric Antigen Receptor (CAR) T Cells After a Nonmyeloablative Conditioning Regimen in Patients With Metastatic Melanoma and Other Solid Tumors

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.

HealthScout AI summary: This trial enrolls adults with metastatic melanoma (including prior brain metastases) or other relapsed/refractory, IL13Ralpha2-expressing solid tumors to receive lymphodepleting chemotherapy followed by systemic infusion of autologous CAR T cells targeting IL13Ralpha2, a tumor-associated antigen. Patients must have good performance status and tumors confirmed to express IL13Ralpha2 by immunohistochemistry.

ClinicalTrials.gov ID: NCT04119024

A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of TROP2-Directed Antibody-Drug Conjugate LCB84, as a Single Agent and in Combination With an Anti-PD-1 Ab, 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.

HealthScout AI summary: Eligible patients are adults with advanced, refractory solid tumors of any histology (including those with stable, treated CNS metastases) and good performance status. The trial evaluates LCB84, a TROP2-targeted antibody-drug conjugate delivering MMAE, given alone or in combination with an anti-PD-1 antibody.

ClinicalTrials.gov ID: NCT05941507

A Phase I/IIa Image-Guided, Alpha-Particle Therapy Study of [203Pb]Pb-PSV359 and [212Pb]Pb-PSV359 in Patients With Solid Tumors That Are Known to be Fibroblast Activation Protein (FAP)-Positive

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, FAP-positive solid tumors who have progressed on or lack standard therapy, using [203Pb]Pb-PSV359 SPECT imaging to confirm FAP expression and [212Pb]Pb-PSV359, a FAP-targeted alpha-emitting peptide-radiopharmaceutical, for systemic therapy.

ClinicalTrials.gov ID: NCT06710756

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.

HealthScout 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.

HealthScout 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.

HealthScout 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 Ia/Ib, Open Label, Multicenter, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Checkpoint Inhibitor in Patients 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.

HealthScout AI summary: Adults with incurable, locally advanced or metastatic solid tumors (e.g., NSCLC, HNSCC, melanoma, TNBC, GI, cervical, CRC, urothelial, clear cell RCC, HCC) receive RO7502175, an afucosylated anti-CCR8 IgG1 designed to deplete intratumoral Tregs via enhanced ADCC, as monotherapy or combined with PD-(L)1 inhibitors (atezolizumab or pembrolizumab). Eligible patients have ECOG 0–1, measurable disease, and no active infections, autoimmune disease, or untreated CNS metastases.

ClinicalTrials.gov ID: NCT05581004

A Phase 1/2, Open-label, Multicenter, Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Anti-CD70 Allogeneic CRISPR-Cas9-Engineered T Cells (CTX131) in Adult Subjects With Relapsed or 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.

HealthScout AI summary: Adults with unresectable/metastatic relapsed or refractory clear cell RCC, cervical, pancreatic, esophageal cancers, or malignant pleural mesothelioma receive a single infusion of CTX131, an allogeneic CRISPR–Cas9–engineered CD70‑directed CAR T cell (TRAC knock-in; B2M, CD70, Regnase‑1, TGFBR2 knockouts) after lymphodepleting chemotherapy. Designed to enhance expansion/persistence and resist TGF‑β–mediated suppression; excludes prior anti‑CD70 therapy and significant CNS/cardiac/pulmonary disease or active infections.

ClinicalTrials.gov ID: NCT05795595