Clinical trialPhase 1 / Phase 2Terminated
A Phase I/II Study of OBI-3424 in Subjects with Advanced Solid Tumors
- Outcome
- Stopped earlyLittle evidence of clinical activity in tumor types enrolled (Enrollment)
- Phase
- Phase 1 / Phase 2
- Status
- Terminated
- Study type
- Interventional
- Start
- 2 July 2018
- Expected end
- 21 March 2024
- Enrollment
- 68 participants
- Sites
- 5
- Primary outcomes
- Incidence and severity of adverse events (AEs); Assess safety changes in electrocardiogram (ECG); Assess safety changes of body weight.; Number of participants with dose limiting toxicities (DLTs); Define the Recommended Phase 2 Dose (RP2D)
- Sponsor
- Industry
- Results posted
- No
- Last update
- 15 October 2024
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Source text
Brief summary public domain (ClinicalTrials.gov)
A first-in-human open-label, Phase I/II study to evaluate the safety, tolerability, MTD/RP2D, PK, and preliminary efficacy of OBI-3424 administered as a single agent.
Papers 2
- Builds on itPhase 2 dose-expansion trial of OBI-3424, a DNA-alkylating prodrug, in patients with advanced solid tumors expressing A… DOI 10.1093/oncolo/oyag254↗
- Builds on itPhase 1 dose-escalation study evaluating the safety, pharmacokinetics, and clinical activity of OBI-3424 in patients wi… DOI 10.1038/s41416-023-02280-4↗