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OncoMatch/Clinical Trials/NCT04954599

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

Is NCT04954599 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including CP-506 and Carboplatin for unspecified adult solid tumor, protocol specific.

Phase 1/2RecruitingMaastricht University Medical CenterNCT04954599Data as of May 2026

Treatment: CP-506 · Carboplatin · Immune checkpoint inhibitorA 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

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Extracted eligibility criteria

Cancer type

Tumor Agnostic

Disease stage

Metastatic disease required

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Must have received: alkylating agent

Patients who were previously responsive to alkylating agent (Partial Response/Complete Response according to RECIST criteria)

Cannot have received: anticancer therapy (including radiotherapy)

Patients who have received anticancer therapy (including radiotherapy) within 4 weeks of inclusion

Cannot have received: anticancer therapy (including radiotherapy)

Exception: carboplatin

Patients who have received anticancer therapy (including radiotherapy) within 4 weeks of inclusion with exclusion of carboplatin

Cannot have received: anticancer therapy (including radiotherapy)

Exception: ICI

Patients who have received anticancer therapy (including radiotherapy) within 4 weeks of inclusion with exception of ICI

Cannot have received: allogeneic/autologous bone marrow or solid organ transplantation

Prior allogeneic/autologous bone marrow or solid organ transplantation

Lab requirements

Blood counts

ANC ≥ 1500/µL; Hemoglobin ≥ 9.0 g/dL; Platelets ≥ 100,000/µL

Kidney function

Creatinine ≤ 1.5 × ULN

Liver function

Total bilirubin ≤ 1.5 × ULN OR direct bilirubin ≤ ULN for participants with total bilirubin levels >1.5 × ULN; AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN (≤ 5 × ULN for participants with liver metastases)

Cardiac function

INR ≤ 1.5 × ULN (or within therapeutic ranges for participants on anticoagulant treatment)

Must have adequate organ and bone marrow function, defined as the following: ANC ≥ 1500 µL; Hemoglobin ≥ 9.0 g/dL; Platelets ≥ 100 000 µL; Total bilirubin ≤ 1.5 × ULN OR direct bilirubin ≤ ULN for participants with total bilirubin levels >1.5 × ULN; AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN (≤ 5 × ULN for participants with liver metastases); Creatinine ≤ 1.5 × ULN; Coagulation: INR ≤ 1.5 × ULN (or within therapeutic ranges for participants on anticoagulant treatment)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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