START: Safety and Anti-Tumor Activity of PeptiCRAd-1 in Treatment of Cancer

Sponsor
Valo Therapeutics Oy
Study ID
NCT05492682
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • PeptiCRAd-1 — DRUG
    All patients will receive PeptiCRAd-1.
  • Cyclophosphamide — DRUG
    All patients will be pre-treated with one single dose of Cyclophosphamide.
  • Pembrolizumab — DRUG
    All patients will receive 6 doses of Pembrolizumab within the study.

Study Details

This study is being conducted to explore the immunological mechanism of action of Peptide-coated Conditionally Replicating Adenovirus-1 (PeptiCRAd-1) plus Checkpoint inhibitor (CPI) therapy in multiple cancer types, as well as to obtain early information on the safety of this combination therapy.

Key Dates

First listed
Aug 8, 2022
Start date
Feb 2, 2023
Status verified
May 2026
Primary completion
Apr 30, 2027
Completion
May 31, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Patients in Cohort 1 are treated with PeptiCRAd-1 administered i.t.
  • Experimental: Cohort 2
    Patients in Cohort 2 are treated with PeptiCRAd-1 administered i.t. and s.c.

Primary Outcome Measure

Measurement of Safety and tolerability indexes (Incidence of TEAEs, SAEs and DLTs as assessed by CTCAE version 5.0 and changes in assessed safety parameters) for PeptiCRAd-1 monotherapy. [ Time Frame: From study protocol day 1 (baseline) until 1 month ]

Central Contacts

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