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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 (Jun 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 Jun 2026Location: Belgium · Netherlands · Spain

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

Treatments studied

Chemotherapy

Carboplatin

Other

CP-506Immune checkpoint inhibitor

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.

Frequently asked questions

Is NCT04954599 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior anticancer therapy (including radiotherapy), anticancer therapy (including radiotherapy), anticancer therapy (including radiotherapy) disqualifies patients from enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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