Neoadjuvant CADI-05 in Combination With Pembrolizumab for Surgically Resectable Locally Advanced Head and Neck Squamous Cell Carcinomas

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Fox Chase Cancer Center
Study ID
NCT07455032
Phase
PHASE1
Status
Recruiting
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Conditions

  • Squamous Cell Carcinoma of Head and Neck

Eligibility Criteria

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

Interventions

  • intradermal injection of CADI-05 — BIOLOGICAL
    CADI-05 will be administered intradermally. Participants will receive 0.2 mL on Day 1 of Week 1, followed by 0.1 mL on Day 1 of Weeks 2, 3, 4, and 5. If needed for safety, the CADI-05 dose will be reduced, and only be administered at 0.1ml on Day 1 of Weeks 2, 3, and 5.
  • Pembrolizumab — BIOLOGICAL
    Pembrolizumab (standard of care treatment) will be administered intravenously at a dose of 200 mg on Day 1 of Week 1 and Day 1 of Week 4.

Study Details

The goal of this clinical trial is to learn if drug CADI-05, when used together with pembrolizumab (an FDA approved immunotherapy), can help treat locally advanced head and neck squamous cell carcinoma (LA-HNSCC) in adults. It will also learn about the safety of drug CADI-05. The main questions it aims to answer are: * Does using CADI-05 together with pembrolizumab help the immune system fight cancer better and lead to better results for patients? * What side effects or health problems might happen when people receive these two treatments? Participants will: * Get pembrolizumab by IV (through a vein) once on day 1 of week 1 and again day 1 of week 4. This is standard of care treatment. * Get CADI-05 as a small injection into the skin once a week for 5 weeks. This is the experimental (research) treatment. * Visit the clinic every week for treatments, checkups and tests for 5 weeks. * Have surgery between week 6 and week 7. * Return to the clinic once for a follow-up visit about 30 days after surgery.

Key Dates

Start date
Apr 8, 2026
Status verified
Apr 2026
Primary completion
Nov 30, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
22 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment with CADI-05 and pembrolizumab
    the neoadjuvant CADI-05 with pembrolizumab

Primary Outcome Measure

Occurrence of dose limiting toxicities (DLTs) by CTCAE ver. 6.0. of CADI-05 and pembrolizumab in patients with surgically resectable LA-HNSCC during the toxicity assessment window. [ Time Frame: From Day 1 of CADI-05 treatment until safety follow-up, for a total of up to 13 weeks. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111
Parth Desai, MD, MBBS
[email protected]
215-728-4300
Jianli Hu, MD, PhD
[email protected]
267-449-1431
Temple University HospitalPhiladelphiaPennsylvania19140
Parth Desai, MD, MBBS
[email protected]
215-707-7777
Jianli Hu, MD, PhD
[email protected]
267-449-1431

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By research site
Fox Chase Cancer Center· Philadelphia, PATemple University Hospital· Philadelphia, PA

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