Clinical Trials for Head And Neck Cancer

A Phase 2, Randomized, Multicenter, Open-label, Study of FID-007 in Combination With Cetuximab in Patients With Advanced Head and Neck Squamous Cell Carcinoma

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

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 recurrent/metastatic HNSCC (non–EBV+ NP) after progression on PD-(L)1 therapy, ECOG 0–1, and no prior cetuximab/taxane in the R/M setting receive nanoencapsulated paclitaxel FID-007 (poly(2-ethyl-2-oxazoline) carrier; microtubule-stabilizer) plus fixed-dose cetuximab, comparing two FID-007 dose schedules. Key exclusions include >1 prior systemic R/M line, significant neuropathy, active/untreated brain mets, and strong CYP2C8/3A4 modifier use around PK sampling.

ClinicalTrials.gov ID: NCT06332092

A Phase II Study of ACR-368 and Low Dose Gemcitabine Combination Therapy in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

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 recurrent or metastatic HNSCC (oral cavity, oropharynx, larynx, hypopharynx, including p16/HPV+ unknown primary) after prior PD-1/PD-L1 therapy receive the CHK1/2 inhibitor ACR-368 (prexasertib) plus ultra–low-dose gemcitabine every 2 weeks, with separate cohorts by p16/HPV status. Requires measurable disease, ECOG 0–1, recent tissue for p16/HPV and OncoSignature, and biopsy willingness; key toxicities expected are transient high-grade myelosuppression.

ClinicalTrials.gov ID: NCT06597565

A Phase II, Multicenter, Open-Label Trial of DB-1311 in Combination With BNT327 or DB-1305 in Participants With Advanced/Metastatic Solid Tumors

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

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: Enrolls adults with advanced/metastatic solid tumors—HCC (Child-Pugh A), cervical, melanoma, recurrent/metastatic HNSCC, platinum‑resistant high‑grade serous ovarian, and nonsquamous NSCLC without actionable drivers—ECOG 0–1 and measurable disease. Investigational therapy pairs the B7‑H3–targeted topoisomerase‑I ADC DB‑1311 with either BNT327 (PD‑L1/VEGF‑A bispecific) for HCC/cervical/melanoma/HNSCC or with the TROP2‑directed topoisomerase‑I ADC DB‑1305 for NSCLC.

ClinicalTrials.gov ID: NCT06953089

A Phase 2, Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN 144/LN-145/LN-145-S1) in Patients With Solid Tumors

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

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 or metastatic melanoma (including those previously treated with PD-1 inhibitors or BRAF-targeted therapies), advanced head and neck squamous cell carcinoma, or locally advanced/metastatic non-small cell lung cancer, providing treatment with autologous tumor-infiltrating lymphocyte (TIL) products—lifileucel (LN-144/LN-145) or next-generation PD-1-selected LN-145-S1—either as monotherapy or in combination with immune checkpoint inhibitors (ICIs). Eligibility requires at least one resectable lesion and ECOG 0-1, and excludes active autoimmune disease or untreated symptomatic brain metastases.

ClinicalTrials.gov ID: NCT03645928

Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Patients With Select Solid Tumors

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

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: Enrolling adults with advanced solid tumors requiring an injectable lesion: first-line PD-1–eligible HNSCC (PD-L1 CPS ≥1%, no prior PD-(L)1), cutaneous melanoma with primary resistance or progression on prior PD-(L)1 (BRAF+ should have received/declined targeted therapy), and a closed-to-enrollment non–MSI-H CRC cohort; ECOG 0–1 required. Treatment is intratumoral VV1 (VSV engineered to express IFN-β and NIS; oncolytic/immune-stimulatory) combined with IV cemiplimab every 3 weeks until progression/toxicity.

ClinicalTrials.gov ID: NCT04291105

A Phase 1b/2 Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of Trastuzumab Deruxtecan (T-DXd) Monotherapy and Combinations in Adult Participants With HER2-expressing Gastric Cancer (DESTINY-Gastric-03)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

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/metastatic HER2-expressing gastric/GEJ/esophageal adenocarcinoma (HER2-positive or HER2-low) receive trastuzumab deruxtecan (anti‑HER2 antibody–drug conjugate delivering a topoisomerase I inhibitor) as monotherapy or combined with fluoropyrimidines and/or checkpoint inhibitors (durvalumab, pembrolizumab, or investigational bispecifics volrustomig [PD‑1/CTLA‑4] and rilvegostomig [PD‑1/TIGIT]); first-line cohorts include a comparator of trastuzumab plus fluoropyrimidine/platinum. Prior trastuzumab exposure is required only for a post-trastuzumab cohort, with key exclusions including active ILD/pneumonitis and untreated CNS metastases.

ClinicalTrials.gov ID: NCT04379596

A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors

Active drug

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

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

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.

TrialFetch AI summary: This trial evaluates MDNA11, an IL-2 Superkine targeting the IL-2 beta receptor to enhance anti-tumor immunity, administered alone or with pembrolizumab, in adult patients with locally advanced or metastatic solid tumors. Eligible patients must have an ECOG performance status of 0 or 1 and adequate organ function.

ClinicalTrials.gov ID: NCT05086692

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

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 involves patients with metastatic or unresectable non-small cell lung cancer and other solid tumors who receive BL-B01D1, a bispecific antibody-drug conjugate targeting EGFR and HER3, designed with a novel topoisomerase I inhibitor payload. The study evaluates different dosing schedules to determine safety, tolerability, and efficacy, particularly aiming to optimize dosing based on promising response rates in EGFR-mutated NSCLC and other cancer types.

ClinicalTrials.gov ID: NCT05983432

A Phase 1/2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

Active drug

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

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

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.

TrialFetch AI summary: This trial enrolls adults (and selected adolescents) with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation, who have progressed after at least one prior therapy, to receive rezatapopt (PC14586)—a selective oral p53 reactivator targeting the Y220C mutant—as monotherapy. Patients must have ECOG 0-1 and measurable disease; cohorts include ovarian, lung, breast, endometrial, and other solid tumors, with KRAS wild-type status required for some.

ClinicalTrials.gov ID: NCT04585750

An Open-Label, Multicenter, Phase 1/1b Study of JANX008 in Subjects with Advanced or Metastatic Solid Tumor 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.

TrialFetch AI summary: This trial enrolls adults with advanced or metastatic EGFR-expressing solid tumors (including NSCLC, SCCHN, CRC, RCC, SCLC, PDAC, or TNBC) who have progressed on or are intolerant to standard therapies, to receive JANX008—a protease-activated bispecific antibody that redirects T cells (via CD3) to target tumor cells (via EGFR), aiming to reduce off-tumor toxicity.

ClinicalTrials.gov ID: NCT05783622