CyPep-1 Injections in Cancer Inducing Lymphocyte Infiltrate Accumulations

Sponsor
Cytovation AS
Study ID
NCT04260529
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Advanced Solid Tumor Malignancy

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 I/IIa trial is designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of CyPep-1 when administered directly into malignant tumors in monotherapy and in combination with anti programmed cell death protein 1(anti-PD-1) antibody pembrolizumab. Additionally, the trial will monitor anti-tumor effects on both injected lesions and distant non-injected deposits.

Key Dates

Start date
Apr 30, 2020
Status verified
Jan 2026
Primary completion
Jul 5, 2024
Completion
Jul 5, 2024

Study Design

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

Arms

  • Experimental: Phase I Cohort 1
    Dose escalation at 0.5 mg (milligrams)/mL, n=3
  • Experimental: Phase I Cohort 2
    Dose escalation at 2 mg/mL, n=5
  • Experimental: Phase I Cohort 3
    Dose escalation at 5 mg/mL, n=6
  • Experimental: Phase IIa: Arm A
    CyPep-1 5.0mg/mL Monotherapy
  • Experimental: Phase IIa Arm B
    The safety and tolerability of CyPep-1 in combination with pembrolizumab was evaluated in a cohort of 15 patients in total, using a staggered approach. Initially, 3 patients received CyPep-1 at Recommended Phase 2 Dose (RP2D) in combination with pembrolizumab once every 6 weeks (Q6W)
  • Experimental: Phase IIa Arm C Cohort 4
    The safety and tolerability of at least 2 dose levels of CyPep-1, the RP2D and the dose immediately below that, were evaluated when CyPep-1 was administered IT using ultrasound guidance to one metastatic lesion in the liver (Cohort 4: 2 mg/mL, n=6)
  • Experimental: Phase IIa Arm C Cohort 5
    The safety and tolerability of at least 2 dose levels of CyPep-1, the RP2D and the dose immediately below that, were evaluated when CyPep-1 was administered intratumoral (IT) using ultrasound guidance to one metastatic lesion in the liver. The RP2D (Cohort 5: 5 mg/mL, n=6).
  • Experimental: Phase IIa Arm D
    The safety and tolerability of CyPep-1 at RP2D was planned to be further evaluated with focus on assessing efficacy signals of CyPep-1 monotherapy in 30 patients with cutaneous melanoma.

Primary Outcome Measure

Type and Number of Adverse Events (AEs) [ Time Frame: From Informed Consent Form (ICF) signing until Follow Up (FU) or until End of Treatment (EoT) visit. After FU visit, only ongoing AEs or Serious Adverse Events (SAEs) related to CyPep-1 were collected. Duration: up to a maximum of 28 months. ]

Related coverage on Hipa.ai