Clinical Trials for Head And Neck Cancer

A Phase 1, First-in-Human, Open-Label, Multi-Center, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LB-LR1109 for the Treatment of 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 or metastatic NSCLC, head and neck squamous cell carcinoma, renal cell carcinoma, urothelial carcinoma, or melanoma who lack a suitable standard treatment option receive escalating doses of LB-LR1109 monotherapy. This investigational antibody blocks the inhibitory immune receptor LILRB1 to enhance antitumor immune activity.

ClinicalTrials.gov ID: NCT06332755

A Phase 1/2, Open-Label, Multi-Center, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0005 in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements (TRIDENT-1)

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 adults and adolescents with advanced or metastatic solid tumors (including NSCLC) harboring ALK, ROS1, or NTRK1-3 gene rearrangements to receive repotrectinib, a next-generation oral tyrosine kinase inhibitor designed to overcome resistance mutations in these oncogenic fusions. Eligible patients may have received prior TKIs and may have asymptomatic CNS metastases.

ClinicalTrials.gov ID: NCT03093116

A Phase 1/2a, Multicenter, First-in-human, Open-label Clinical Trial Evaluating MDX2001 Monotherapy 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.

TrialFetch AI summary: Adults with metastatic solid tumors, measurable disease, and ECOG performance status 0–1 receive intravenous MDX2001 monotherapy. MDX2001 is an investigational tetraspecific antibody that binds c-MET and TROP2 on tumors while engaging CD3 and providing CD28 costimulation to promote tumor-directed T-cell activity.

ClinicalTrials.gov ID: NCT06239194

A Phase 1, First-in-human, Multicentre, Open-label, Dose Escalation Study of [225Ac]-FPI-2068 in Adult Patients 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 advanced or recurrent solid tumors that have progressed after prior treatment and lack suitable standard options receive [225Ac]-FPI-2068, an investigational EGFR/c-MET-targeted alpha-emitting radioimmunotherapy. A nonradioactive FPI-2053 antibody predose is used to optimize biodistribution, with [111In]-FPI-2107 SPECT imaging used to assess uptake and dosimetry.

ClinicalTrials.gov ID: NCT06147037

A Phase 1, Open-label, Multicenter, Dose-escalation and Cohort Expansion Study of OKN4395, a Triple Antagonist of EP2, EP4, and DP1 Prostanoid Receptors, as Monotherapy and in Combination With Pembrolizumab, 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.

TrialFetch AI summary: Patients with locally advanced or metastatic solid tumors who have exhausted or are unsuitable for standard treatment receive oral OKN4395, an investigational EP2/EP4/DP1 prostanoid receptor antagonist, alone or with the anti–PD-1 antibody pembrolizumab. Expansion cohorts give OKN4395 alone for selected sarcomas and pancreatic adenocarcinoma, and the combination for NSCLC, microsatellite-stable or MSI-low colorectal cancer, and head and neck squamous cell carcinoma.

ClinicalTrials.gov ID: NCT06789172

A Phase I/II, Open-Label, Multicenter Study of ALE.P02 (Claudin-1 Targeted Antibody-Drug Conjugate) as a Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+Squamous 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 CLDN1-positive, unresectable or metastatic squamous NSCLC, head and neck, esophageal, or cutaneous carcinoma who are refractory to or intolerant of standard systemic therapy receive intravenous ALE.P02 monotherapy. ALE.P02 is an investigational claudin-1–targeted antibody–drug conjugate that delivers a tubulin-inhibiting payload.

ClinicalTrials.gov ID: NCT06747585

A Phase 1/1b Study of VET3-TGI Administered Alone and in Combination With Pembrolizumab 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.

TrialFetch AI summary: Adults with measurable, advanced unresectable or metastatic solid tumors and no suitable curative treatment receive intratumoral or intravenous VET3-TGI, alone or with pembrolizumab. VET3-TGI is an oncolytic vaccinia virus engineered to express CXCR3 and IL-12 and inhibit TGF-β to promote tumor killing and antitumor immunity.

ClinicalTrials.gov ID: NCT06444815

A Phase I/II, Dose-escalation and Dose-optimization Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of MT-4561 in Patients With Various Advanced Solid Tumors and to Evaluate Effect of MT-4561 on Pharmacokinetics of Oral Midazolam

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 selected advanced solid tumors, measurable disease, and ECOG performance status 0–1 receive once-weekly intravenous MT-4561, an investigational drug designed to degrade BRD4. Dose escalation is followed by planned dose optimization and an assessment of MT-4561’s effect on oral midazolam pharmacokinetics.

ClinicalTrials.gov ID: NCT06943521

A Phase 1/2 Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ARV-806 in Participants With KRAS G12D Mutated 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.

TrialFetch AI summary: Adults with previously treated unresectable or metastatic KRAS G12D–mutated solid tumors are eligible for dose escalation; dose expansion is limited to pancreatic ductal adenocarcinoma after at least one prior systemic therapy. All receive IV ARV-806, an investigational PROTAC designed to degrade mutant KRAS G12D, weekly or every two weeks.

ClinicalTrials.gov ID: NCT07023731

A Phase 1a/1b, Multicenter, Open-label, Dose Escalation/Expansion, Multiple-dose Study to Evaluate the Safety and Activity of DR-0202 in Patients With Locally Advanced or Metastatic, Relapsed or Refractory 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: Patients with measurable, unresectable locally advanced or metastatic epithelial carcinomas that have relapsed or are refractory after at least two prior treatment lines, have no standard options, and have ECOG performance status 0–1 receive DR-0202 every two weeks. DR-0202 is an investigational bispecific antibody designed to bring myeloid immune cells into contact with tumor cells; its tumor-cell target has not been disclosed.

ClinicalTrials.gov ID: NCT06999187