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Hypoxia Activated Prodrug

Module 3A Combination with Immune Checkpoint Inhibitor Multiple Ascending Dose for Solid Tumors

Phase 1 & 2

Recruiting

Led By Henk Verheul, MD, PhD

Research Sponsored by Maastricht University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline until 60 days after last administration of cp-506

Awards & highlights

No Placebo-Only Group

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline until 60 days after last administration of cp-506

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline until 60 days after last administration of cp-506

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline until 60 days after last administration of cp-506 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of clinically significant abnormal measurements in physical examination, vital signs, electrocardiogram (ECG), lab tests and ECOG performance status

Incidence of treatment-emergent adverse events including dose-limiting toxicities

Secondary study objectives

Area under curve of CP-506 plasma concentration

Determine the minimal biological effective dose

Objective Response Rate

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Group I: Module 3B Combination with carboplatin Dose Expansion CohortExperimental Treatment2 Interventions

Expansion cohort dosing CP-506 in combination with Immune Checkpoint Inhibitor in patients at recommended phase 2 dose (RP2D) Intervention: Drug: CP-506

Group II: Module 3A Combination with Immune Checkpoint Inhibitor Multiple Ascending DoseExperimental Treatment2 Interventions

Multiple ascending dose cohorts dosing CP-506 in combination with Immune Checkpoint Inhibitor in all patients up to a maximally tolerated or maximally feasible dose Intervention: Drug: CP-506

Group III: Module 2B Combination with carboplatin Dose Expansion CohortExperimental Treatment2 Interventions

Expansion cohort dosing CP-506 in combination with carboplatin in patients at recommended phase 2 dose (RP2D) Intervention: Drug: CP-506

Group IV: Module 2A Combination with carboplatin Multiple Ascending DoseExperimental Treatment2 Interventions

Multiple ascending dose cohorts dosing CP-506 in combination with carboplatin in all patients up to a maximally tolerated or maximally feasible dose Intervention: Drug: CP-506

Group V: Module 1B Monotherapy Dose Expansion CohortExperimental Treatment1 Intervention

Expansion cohort dosing CP-506 monotherapy in patients at recommended phase 2 dose (RP2D) Intervention: Drug: CP-506

Group VI: Module 1A Monotherapy Multiple Ascending DoseExperimental Treatment1 Intervention

Multiple ascending dose cohorts dosing CP-506 monotherapy in all patients up to a maximally tolerated or maximally feasible dose Intervention: Drug: CP-506

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6120

Immune checkpoint inhibitor

2017

Completed Phase 1

~142970