Clinical trialPhase 1Recruiting
HWS116 Monotherapy in Patients With Advanced Solid Tumors
A Phase I, Single-Arm, Open-Label, Dose-Escalation and Expansion Study of HWS116 Injection in Advanced Solid Tumors
- Outcome
- Ongoing
- Phase
- Phase 1
- Status
- Recruiting
- Study type
- Interventional
- Start
- 7 April 2026
- Expected end
- 28 February 2028
- Enrollment
- 56 participants
- Sites
- 1
- Primary outcomes
- Incidence of Treatment-Emergent Adverse Events (Part 1 Only); Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (Part 2 Only)
- Sponsor
- Industry
- Results posted
- No
- Last update
- 28 April 2026
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Brief summary public domain (ClinicalTrials.gov)
This is a Phase I open-label study that will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HWS116 monotherapy in patients with advanced solid tumors.
Detailed description public domain (ClinicalTrials.gov)
This trial is an open-label, dose-escalation/expansion first-in-human study of HWS116, divided into two parts: Part 1 (Dose Escalation): This part plans to enroll patients with advanced solid tumors who have no standard treatment, have failed standard treatment, or are ineligible for standard treatment. Patients will receive monotherapy with HWS116 at pre-specified escalating doses. The objectives are to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HWS116 in patients. Part 2 (Dose Expansion): This part intends to enroll patients with advanced solid tumors who have no standard treatment, have failed standard treatment, or are ineligible for standard treatment. Patients will receive continuous administration of HWS116 to provide additional clinical data for evaluating preliminary efficacy and determining the Phase 2 recommended dose (P2RD) and potential indications.