RecruitingPhase 1Phase 2NCT04954599

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

Phase 1/2 Modular Dose Escalation With Cohort Expansion of CP-506 (HAP) in Patients With Solid Tumor Types With High Incidence of HRD/FAD in Monotherapy or With Carboplatin or Patients With Solid Tumour and OPD Receiving ICI


Sponsor

Maastricht University Medical Center

Enrollment

126 participants

Start Date

May 30, 2023

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 1/2 study is testing a new drug called CP-506 — which targets tumors that have defective DNA repair systems — in people with advanced or metastatic solid tumors. It can be used alone or in combination with carboplatin (chemotherapy) or immune checkpoint inhibitors. It may be especially relevant for people with BRCA mutations or similar DNA repair defects. **You may be eligible if...** - You are 18 or older with an advanced or metastatic solid tumor - Standard treatment options are no longer working or available - Your tumor has evidence of DNA repair defects (e.g., BRCA1/2 mutation), or you have certain cancer types (ovarian, breast, pancreatic, prostate, head and neck) with higher rates of these defects - You have at least one measurable tumor on scans - You are in generally good health (ECOG 0–2) - Your blood counts and organ function are adequate **You may NOT be eligible if...** - You have significant heart problems (recent heart attack, severe heart failure, irregular heart rhythms) - You have active or untreated brain metastases - You have a history of autoimmune disease that required systemic treatment in the past 2 years - You have HIV, active hepatitis B or C - You have known allergies to alkylating agents - You are pregnant or breastfeeding - You have received cancer treatment within the past 4 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCP-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

DRUGCarboplatin

Antineoplastic agent, ATC Code: LO1X A02

DRUGImmune checkpoint inhibitor

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


Locations(5)

Institut Jules Bordet

Brussels, Belgium

UZ Gent

Ghent, Belgium

Academisch Ziekenhuis Maastricht (Leading Centre)

Maastricht, Limburg, Netherlands

Erasmus MC

Rotterdam, Netherlands

Institut Vall d'Hebron

Barcelona, Spain

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NCT04954599


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