Clinical Trials for Head And Neck Cancer

A Phase 1, Multicenter, Open-label, First-in-human, Dose Escalation and Expansion Study of DM005 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.

TrialFetch AI summary: Adults with advanced or metastatic non-small-cell lung, gastroesophageal, colorectal, hepatocellular, pancreatic, or head and neck squamous cell cancer that has progressed on standard therapy, or who cannot tolerate it, receive intravenous DM005 monotherapy every 21 days. DM005 is an investigational bispecific antibody–drug conjugate targeting EGFR and MET that delivers a topoisomerase I inhibitor payload.

ClinicalTrials.gov ID: NCT06515990

A Phase 1/2, First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-1418 as a Single Agent and in Combination Therapy in Patients With Locally 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.

TrialFetch AI summary: Adults aged 18–75 with measurable locally advanced or metastatic protocol-specified epithelial solid tumors, ECOG 0–1, and applicable molecular testing are eligible. Treatment is IV AVZO-1418, an EGFR/HER3-targeted bispecific antibody–drug conjugate delivering a topoisomerase I inhibitor payload, as monotherapy with potential protocol-defined combination cohorts.

ClinicalTrials.gov ID: NCT07038343

A Phase 1b/II Study of Intratumoral CD40 Agonist 2141-V11 in Combination With Anti PD-1 and 5-Fluorouracil Therapy in Patients With Advanced Gastroesophageal Adenocarcinoma

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.

TrialFetch AI summary: Adults with unresectable locally advanced or metastatic esophageal, gastric, or gastroesophageal junction adenocarcinoma are eligible if they have had 3–9 months of first-line fluoropyrimidine plus anti-PD-1 therapy without progression and have an endoscopically accessible primary tumor. Treatment adds intratumoral 2141-V11, an Fc-engineered CD40 agonist antibody, to nivolumab with a fluoropyrimidine (mandatory in the safety lead-in).

ClinicalTrials.gov ID: NCT07818018

Phase I Study of MEM-288 Oncolytic Virus Alone and in Combination With Nivolumab in Solid Tumors Including Non-Small Cell Lung Cancer (NSCLC)

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

TrialFetch AI summary: Adults with ECOG 0–1, measurable disease, and an injectable, biopsy-accessible lesion may receive intratumoral MEM-288 alone after standard therapy for selected advanced solid tumors, or with nivolumab after first progression on frontline PD-1/PD-L1–based therapy for advanced NSCLC. MEM-288 is an oncolytic adenovirus designed to lyse tumor cells and express interferon beta and a CD40-ligand construct to stimulate antitumor immunity; nivolumab inhibits PD-1.

ClinicalTrials.gov ID: NCT05076760

A Phase 1 Study Evaluating the Safety, Tolerability, and Efficacy of BL-B01D1 in Subjects With Metastatic or Unresectable Non-Small Cell Lung Cancer and Other Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

TrialFetch AI summary: This study enrolls patients with incurable locally advanced or metastatic epithelial solid tumors, particularly NSCLC, who have measurable disease and ECOG performance status 0–1. Patients receive intravenous BL-B01D1 (izalontamab brengitecan), an investigational EGFR/HER3-targeting bispecific antibody–drug conjugate that delivers a topoisomerase I inhibitor, on one of two 21-day dosing schedules.

ClinicalTrials.gov ID: NCT05983432

A Phase 1/2, Open-label, Dose-escalation, and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Therapeutic Activity of GI-101 As a Single Agent and in Combination with Pembrolizumab, Lenvatinib or Local Radiotherapy in Patients with Advanced or Metastatic Solid Tumors (Keynote B59)

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

TrialFetch AI summary: Adults with advanced or metastatic solid tumors, measurable disease, and ECOG performance status 0–1 receive GI-101 or GI-101A alone or in combination with pembrolizumab; GI-101 may also be combined with lenvatinib or local radiotherapy. GI-101 is a CD80–IL-2-variant fusion protein designed to counter CTLA-4-mediated suppression and stimulate cytotoxic T and natural-killer cells; GI-101A is a manufacturing-optimized formulation.

ClinicalTrials.gov ID: NCT04977453

A Dose-Escalation and Expansion Study of the Safety and Efficacy of XL092 in Combination With Immuno-Oncology Agents in Subjects With Unresectable Advanced or Metastatic Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

TrialFetch AI summary: Adults with unresectable locally advanced or metastatic solid tumors, including renal, prostate, urothelial, liver, lung, colorectal, and head and neck cancers, receive oral zanzalintinib alone or with nivolumab, nivolumab plus ipilimumab, or nivolumab plus relatlimab. Zanzalintinib inhibits VEGFR2, MET, and TAM kinases; the checkpoint inhibitors target PD-1, CTLA-4, and LAG-3, respectively.

ClinicalTrials.gov ID: NCT05176483

A Phase 1a/1b Study to Evaluate the Safety and Tolerability of STK-012 As a Single Agent and in Combination Therapy in Patients with Selected Advanced Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

TrialFetch AI summary: Patients with selected advanced solid tumors receive STK-012 alone or with pembrolizumab, with some cohorts also receiving pemetrexed and carboplatin; most dose-escalation cohorts require prior standard therapy, while some expansion cohorts allow untreated metastatic disease, including PD-L1-negative NSCLC. STK-012 is an investigational IL-2 receptor α/β-biased partial agonist designed to preferentially stimulate antigen-experienced CD25-positive T cells.

ClinicalTrials.gov ID: NCT05098132

A Phase 1/2, First-in-Human, Open Label, Dose Escalation and Expansion Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

TrialFetch AI summary: This trial enrolls patients with unresectable locally advanced or metastatic solid tumors who have exhausted, cannot tolerate, or are ineligible for standard therapy, with expansion cohorts focused on melanoma, renal cell carcinoma, and selected NSCLC. Patients receive imneskibart (AU-007), an anti-IL-2 antibody that blocks IL-2 binding to CD25, alone or with aldesleukin; some cohorts also receive avelumab or nivolumab.

ClinicalTrials.gov ID: NCT05267626

A Phase 1 Study of SGN-B6A in Advanced Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

TrialFetch AI summary: This study enrolls patients with measurable metastatic or unresectable solid tumors and ECOG 0–1, including previously treated patients in monotherapy cohorts and treatment-naive patients with advanced NSCLC, head and neck, or esophageal cancer in combination cohorts. Patients receive sigvotatug vedotin, an integrin β6–targeting antibody–drug conjugate that delivers the microtubule-disrupting payload MMAE, alone or with pembrolizumab, with or without platinum chemotherapy.

ClinicalTrials.gov ID: NCT04389632