drugset / Trial / NCT04954599
Phase 1/2 Clinical Trial of CP-506 (HAP) in Monotherapy or With Carboplatin or ICI
Phase 1/2
Recruiting
126 enrolled
Maastricht University Medical Center
Academisch Ziekenhuis Maastricht · collabErasmus Medical Center · collabJules Bordet Institute · collabUniversity Ghent · collabVall d'Hebron Institute of Oncology · collab
Non-randomizedSequentialOpen-labelTreatment
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
- Start
- 2023-05-30
- Primary completion
- 2027-02
- Completion
- 2027-05
Publications
- Background Fu Z, Mowday AM, Smaill JB, Hermans IF, Patterson AV. Tumour Hypoxia-Mediated Immunosuppression: Mechanisms and Therapeutic Approaches to Improve Cancer Immunotherapy. Cells. 2021 Apr 24;10(5):1006. doi: 10.3390/cells10051006.
- Background van der Wiel AMA, Jackson-Patel V, Niemans R, Yaromina A, Liu E, Marcus D, Mowday AM, Lieuwes NG, Biemans R, Lin X, Fu Z, Kumara S, Jochems A, Ashoorzadeh A, Anderson RF, Hicks KO, Bull MR, Abbattista MR, Guise CP, Deschoemaeker S, Thiolloy S, Heyerick A, Solivio MJ, Balbo S, Smaill JB, Theys J, Dubois LJ, Patterson AV, Lambin P. Selectively Targeting Tumor Hypoxia With the Hypoxia-Activated Prodrug CP-506. Mol Cancer Ther. 2021 Dec;20(12):2372-2383. doi: 10.1158/1535-7163.MCT-21-0406. Epub 2021 Oct 8.
- Background Solivio MJ, Stornetta A, Gilissen J, Villalta PW, Deschoemaeker S, Heyerick A, Dubois L, Balbo S. In Vivo Identification of Adducts from the New Hypoxia-Activated Prodrug CP-506 Using DNA Adductomics. Chem Res Toxicol. 2022 Feb 21;35(2):275-282. doi: 10.1021/acs.chemrestox.1c00329. Epub 2022 Jan 20.
- Background Jackson-Patel V, Liu E, Bull MR, Ashoorzadeh A, Bogle G, Wolfram A, Hicks KO, Smaill JB, Patterson AV. Tissue Pharmacokinetic Properties and Bystander Potential of Hypoxia-Activated Prodrug CP-506 by Agent-Based Modelling. Front Pharmacol. 2022 Feb 8;13:803602. doi: 10.3389/fphar.2022.803602. eCollection 2022.
- Yaromina A, Koi L, Schuitmaker L, van der Wiel AMA, Dubois LJ, Krause M, Lambin P. Overcoming radioresistance with the hypoxia-activated prodrug CP-506: A pre-clinical study of local tumour control probability. Radiother Oncol. 2023 Sep;186:109738. doi: 10.1016/j.radonc.2023.109738. Epub 2023 Jun 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CP-506 | Other / unclassified | — | Intravenous |
| Background | Atezolizumab | Monoclonal antibody | — | — |
| Background | Avelumab | Monoclonal antibody | — | — |
| Background | Carboplatin | Small molecule | — | — |
| Background | Cemiplimab | Monoclonal antibody | — | — |
| Background | Durvalumab | Monoclonal antibody | — | — |
| Background | Ipilimumab | Monoclonal antibody | — | — |
| Background | Nivolumab | Monoclonal antibody | — | — |
| Background | Pembrolizumab | Monoclonal antibody | — | — |