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Phase 1/2 Clinical Trial of CP-506 (HAP) in Monotherapy or With Carboplatin or ICI

NCT04954599 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2025-10-07

No results posted yet for this study

Summary

A modular, first time in human, open label, multiple dose, accelerated escalation with cohort expansion study of the safety and pharmacokinetics of intravenous infusion of CP-506, a tumor agnostic Hypoxia Activated Prodrug in patients with HRD/FAD solid tumours or tumor types with high incidence of HRD/FAD in monotherapy or in combination with carboplatin or patients with solid tumour and oligoprogressive disease receiving immune checkpoint inhibitors (ICI): a phase I-IIa clinical trial

Conditions

  • Unspecified Adult Solid Tumor, Protocol Specific

Interventions

DRUG

CP-506

CP-506 is a hypoxia-activated DNA alkylating agent specifically designed to have a bystander effect, aqueous solubility, oral bioavailability, and no off-mechanism activation by the human aerobic reductase AKR1C3

DRUG

Carboplatin

Antineoplastic agent, ATC Code: LO1X A02

DRUG

Immune checkpoint inhibitor

Drug that blocks immune checkpoint proteins: PD-1, PD-L1, CTLA-4

Sponsors & Collaborators

  • Erasmus Medical Center

    collaborator OTHER

  • Jules Bordet Institute

    collaborator OTHER

  • Academisch Ziekenhuis Maastricht

    collaborator OTHER

  • Vall d'Hebron Institute of Oncology

    collaborator OTHER

  • University Ghent

    collaborator OTHER

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Loes Jansen, MD · Maastricht University Medical Center

  • Henk Verheul, MD, PhD · Erasmus Medical Center

  • Nuria Kotecki, MD, PhD · Jules Bordet Institute

  • Sylvie Rottey, MD, PhD · UZ Gent

  • Irene Brana, MD, PhD · Institut Vall d'Hebron

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-30
Primary Completion
2027-02-28
Completion
2027-05-31

Countries

  • Belgium
  • Netherlands
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04954599 on ClinicalTrials.gov