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NCT04954599

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
Maastricht University·Phase 1/2·ClinicalTrials.gov·drugNot yet recruiting
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Study focus
Disease/Condition
Unspecified Adult Solid Tumor, Protocol Specific
Drug/Device/Intervention
CP-506
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Maastricht University
Timeline & enrollment
Phase
Phase 1/2
Start date
Oct 01, 2021
End date
Oct 01, 2024
Enrollment
126 participants
Primary outcome

Incidence of treatment-emergent adverse events including dose-limiting toxicities,Incidence of clinically significant abnormal measurements in physical examination, vital signs, electrocardiogram (ECG), lab tests and ECOG performance status

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

ICD-10 classifications
Carcinoma in situ, unspecifiedMalignant neoplasm, without specification of siteMalignant neoplasm, primary site unspecifiedCarcinoma in situ of other and unspecified genital organsMalignant neoplasm: Connective and soft tissue, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT04954599
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT04954599 through Pure Global AI's free database. This Phase 1/2 trial is sponsored by Maastricht University and is currently Not yet recruiting. The study focuses on Unspecified Adult Solid Tumor, Protocol Specific. Target enrollment is 126 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.