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Phase 1/2 Clinical Trial of CP-506 (HAP) in Monotherapy or With Carboplatin or ICI - Trial NCT04954599

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.

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NCT04954599
Phase 1/2
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT04954599
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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

Study Focus

CP-506

Interventional

drug

Sponsor & Location

Maastricht University

Timeline & Enrollment

Phase 1/2

Oct 01, 2021

Oct 01, 2024

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, unspecified
Malignant neoplasm, without specification of site
Malignant neoplasm, primary site unspecified
Carcinoma in situ of other and unspecified genital organs
Malignant neoplasm: Connective and soft tissue, unspecified

Data Source

ClinicalTrials.gov

NCT04954599

Non-Device Trial