Study of HS-10516 Combination Therapy in Patients With Advanced Renal Cell Carcinoma

This is a multicenter, open-label, Phase Ib/II clinical study evaluating the safety, efficacy, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) profiles of HS-10516 in combination with lenvatinib in patients with advanced clear cell renal cell carcinoma (ccRCC) who have progressed after receiving at least one prior line of systemic therapy. The study comprises two distinct phases: a dose exploration phase and a proof-of-concept phase.

Trial Details

NCT ID
NCT07097935
Phase
PHASE1 / PHASE2
Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Status
RECRUITING
Cancer Type
Kidney Cancer
Interventions
  • HS-10516 + Lenvatinib
Locations (sample)
  • Beijing, Beijing Municipality, China|39.9075,116.39723

Key Eligibility Criteria

  • Men or women aged more than or equal to (≥) 18 years.
  • Histologically confirmed unresectable, locally advanced or metastatic clear cell renal cell carcinoma (ccRCC) with disease progression during or af…
  • Patients have at least one target lesion according to RECEST 1.1. The requirements for target lesions are: measurable lesions without local treatme…
  • ECOG performance status was 0-1 and did not deteriorate in the previous 2 weeks.

For full eligibility, visit ClinicalTrials.gov.

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