Actively Recruiting
Study of HS-10516 Combination Therapy in Patients With Advanced Renal Cell Carcinoma
Led by Jiangsu Hansoh Pharmaceutical Co., Ltd. · Updated on 2025-08-01
104
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of HS-10516 Combination Therapy in Patients With Advanced Renal Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Histologically confirmed unresectable, locally advanced, or metastatic clear cell renal cell carcinoma
- Disease progression after at least one prior systemic therapy in advanced setting
- At least one measurable target lesion with specific size requirements
- ECOG performance status of 0 or 1, stable for at least 2 weeks
- Estimated life expectancy greater than 12 weeks
- Women of reproductive age agree to use contraception and avoid breastfeeding during and 12 months after treatment
- Men agree to use adequate contraception during and 12 months after treatment
- Females must have non-childbearing potential
- Signed informed consent form
You will not qualify if you...
- Prior or current use of hypoxia-inducible factor inhibitors
- Prior or current use of lenvatinib
- Use of Chinese herbal medicine with antitumor effects within 2 weeks before first dose or during study
- Cytotoxic chemotherapy or other systemic antitumor therapy within 2 weeks or 5 half-lives before first dose or during study
- Use of large-molecule antitumor drugs within 4 weeks before first dose or during study
- Use of CYP2C19 strong inhibitors/inducers or sensitive substrates within 7 days before first dose or during study
- Local radiotherapy (except brain) within 2 weeks before first dose or extensive bone marrow/large-field radiotherapy within 4 weeks before first dose
- Major surgery within 4 weeks before first dose
- Participation in other interventional clinical trials within 4 weeks before first dose or within 5 half-lives of investigational drugs
- Resting oxygen saturation below 92% at screening
- Severe pulmonary dysfunction requiring oxygen therapy
- Unresolved grade greater than 1 toxicities from prior therapy
- History of second primary malignancy
- Known or suspected active central nervous system metastases or leptomeningeal disease
- Inadequate bone marrow or serious organ dysfunction
- Severe, uncontrolled, or active cardiovascular disease
- Severe or poorly controlled diabetes
- Severe or poorly controlled hypertension
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
Research Team
J
Jun Guo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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