Clinical trialPhase 1 / Phase 2Recruiting
A Phase I/Ⅱ Human Study of HY0001a for Injection in Adult Participants With Advanced Solid Tumors
A Multicenter, Open-label Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Clinical Efficacy of HY0001a for Injection in Patients With Advanced Malignant Solid Tumors
- Outcome
- Ongoing
- Phase
- Phase 1 / Phase 2
- Status
- Recruiting
- Study type
- Interventional
- Start
- 21 July 2025
- Expected end
- September 2027
- Enrollment
- 261 participants
- Sites
- 1
- Primary outcomes
- Dose Escalation (Part One): Incidence and Nature of Dose-Limiting Toxicity (DLT); Dose Escalation (Part One): Percentage of participants experiencing treatment-emergent adverse events (TEAEs); Dose Expansion (Part Two): Objective Response Rate (ORR)
- Sponsor
- Industry
- Results posted
- No
- Last update
- 9 March 2026
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Brief summary public domain (ClinicalTrials.gov)
This is a multicenter, open-label, phase I/Ⅱ study to evaluate the safety, efficacy, and pharmacokinetic (PK)/pharmacodynamic(PD) characteristics of HY0001a for injection in participants with advanced solid tumors.
Detailed description public domain (ClinicalTrials.gov)
This is a first-in-human (FIH), Phase I/II, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of HY0001a for injection in patients with advanced/metastatic solid tumors. HY0001a for injection is administered via intravenous infusion using an accelerated titration method followed by a conventional 3 + 3 study design to identify the maximum tolerated dose (MTD) and dose-limiting toxicities（DLT）. In addition, the maximum-tolerated dose and recommended Phase II dose for HY0001a for injection will be determined.