Clinical Trial

Safety, Pharmacokinetics (PK), and Efficacy of ONC 841 in Advanced Solid Tumors

Recruiting Phase 1
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Summary
This is a Phase I/II open label study of intravenous (IV) infusion of ONC-841 as a single agent or in combination in patients with advanced/metastatic solid tumors. The study will evaluate seven dose levels of ONC-841. The Phase 1 part is dose escalation with 7 dose levels of ONC-841 and the dose expansion in the last dose level. The Phase 2 part will test the combination of ONC-841 with SOC in GBM and in CRC.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2024-04-05; most recent amendment 2026-06-22.
Status change: Not Yet Recruiting → Recruiting 2024-10-01
Trial Details
NCT Number NCT06352359
Lead Sponsor OncoC4, Inc.
Conditions Advanced Solid Tumor
Enrollment 72 participants
Start Date 2024-08-23
Primary Completion 2027-09-30 (estimated)
Study Completion 2027-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-25