A Phase II Study of ACR-368 and Low Dose Gemcitabine in R/M HNSCC

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT06597565
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gemcitabine — DRUG
    Gemcitabine is a standard of care given at ultralow dose in combination with the experimental drug ACR-368.
  • ACR-368 — DRUG
    ACR-368 is an experimental drug.

Study Details

The purpose of the study is to determine the activity and safety of ACR-368 (prexasertib) in combination with gemcitabine in participants with Head and Neck Squamous Cell Carcinoma (HNSCC). Participants will receive the study drugs ACR-368 and a low dose of gemcitabine once every 2 weeks in 4-week cycles and will continue on treatment unless the disease deteriorates.

Key Dates

Start date
Sep 25, 2024
Status verified
Oct 2025
Primary completion
Aug 23, 2028
Completion
Aug 23, 2028

Study Design

Enrollment
43 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A (p16/HPV-neg)
    Participants with p16/HPV-negative recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) will be assigned to Cohort A. Participants will be administered lead-in low dose gemcitabine (LDG) 10 mg/m2 IV Day -7 (+/- 3 days, before Cycle 1 only) followed by ACR-368 105 mg/m2 IV every 2 weeks and LDG 10 mg/m2 every 2 weeks until discontinuation due to disease progression, intolerability, or consent withdrawal. When delay or discontinuation of the treatment is necessary, both ACR-368 and LDG will be delayed or discontinued together.
  • Experimental: Cohort B (p16/HPV-pos)
    Participants with p16/HPV-positive R/M HNSCC will be assigned to Cohort B. Participants will be administered lead-in low dose gemcitabine (LDG) 10 mg/m2 IV Day -7 (+/- 3 days, before Cycle 1 only) followed by ACR-368 105 mg/m2 IV every 2 weeks and LDG 10 mg/m2 every 2 weeks until discontinuation due to disease progression, intolerability, or consent withdrawal. When delay or discontinuation of the treatment is necessary, both ACR-368 and LDG will be delayed or discontinued together.

Primary Outcome Measure

Overall Response Rate: Cohort A [ Time Frame: Up to 24 Months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Kara Hoffman
[email protected]
813-745-6020
Christine Chung, MD (PRINCIPAL_INVESTIGATOR)
Kedar Kirtane, MD (SUB_INVESTIGATOR)
Julie Kish, MD (SUB_INVESTIGATOR)
Guilherme Rabinowits, MD (SUB_INVESTIGATOR)

Find similar trials in Tampa, FL

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Moffitt Cancer Center· Tampa, FL

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