A Study to Evaluate the Safety and Efficacy of CyPep-1 in Combination With Pembrolizumab for the Treatment of Advanced or Metastatic Cancers

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Cytovation AS
Study ID
NCT05383170
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Advanced Breast Cancer
  • Advanced Head and Neck Squamous Cell Carcinoma
  • Advanced Melanoma

Eligibility Criteria

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

Interventions

  • CyPep-1 — DRUG
    Intratumoral injection
  • Pembrolizumab 25 MG/ML [KEYTRUDA®] — DRUG
    IV infusion

Study Details

This Phase 1b/2a study will assess the efficacy, safety, and pharmacodynamics of CyPep-1 when administered directly into measurable tumor lesions in combination with the anti-PD-1 antibody pembrolizumab. Additionally, the study will assess anti-tumor effects of CyPep-1 on injected lesions and non-injected target lesions identified at baseline, as well as local and systemic immunological effects of CyPep-1 in combination with pembrolizumab.

Key Dates

Start date
Mar 21, 2023
Status verified
Oct 2025
Primary completion
Sep 23, 2024
Completion
Sep 23, 2024

Study Design

Enrollment
6 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: advanced or metastatic HNSCC
    The safety and tolerability of CyPep-1 in combination with pembrolizumab will be evaluated in a cohort of 30 subjects in total with advanced or metastatic HNSCC. CyPep-1 will be administered every 2 weeks (Q2W) and pembrolizumab will be administered following a Q6W schedule as per standard of care (SoC).
  • Experimental: Arm B: advanced or metastatic melanoma
    The safety and tolerability of CyPep-1 in combination with pembrolizumab will be evaluated in a cohort of 30 subjects in total with advanced or metastatic melanoma. CyPep-1 will be administered every 2 weeks (Q2W) and pembrolizumab will be administered following a Q6W schedule as per standard of care (SoC).
  • Experimental: Arm C: advanced or metastatic TNBC
    The safety and tolerability of CyPep-1 in combination with pembrolizumab will be evaluated in a cohort of 30 subjects in total with advanced or metastatic TNBC. CyPep-1 will be administered every 2 weeks (Q2W) and pembrolizumab will be administered following a Q6W schedule as per standard of care (SoC).

Primary Outcome Measure

Frequency, and Seriousness of TEAEs [ Time Frame: For each subject, from the time of signing the ICF until 30 days (90 days for SAEs) after the last dose of study treatment up to a maximum of 18 months. ]

Locations (6)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-
City Of HopeDuarteCalifornia91010-
Henry Ford Health SystemDetroitMichigan48202-
University of Pittsburgh Medical CenterPittsburghPennsylvania15213-2582-
Texas Oncology - Baylor Charles A. Sammons Cancer CenterDallasTexas75246-
Houston MethodistHoustonTexas77030-

Related coverage on Hipa.ai

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALCity Of Hope· Duarte, CAHenry Ford Health System· Detroit, MIUniversity of Pittsburgh Medical Center· Pittsburgh, PATexas Oncology - Baylor Charles A. Sammons Cancer Center· Dallas, TXHouston Methodist· Houston, TX

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