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

NCT07097935 | Recruiting Phase 1

• 1 other identifier: HS-10516-103
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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

Advanced Clear Cell Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

• Phase Ib: MTD or RP2D

  MTD or RP2D was determined by number of participants with DLT in dose levels. A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE 5.0).

  Up to 3 months

• Phase II: Objective Response Rate (ORR)

  The percentage of patients who have achieved complete response and partial response, according to response evaluation criteria in solid tumors (RECIST) 1.1 by investigator's assessment.

  Up to 12 months.

Secondary Outcomes (8)

• Incidence and severity of treatment-emergent adverse events

  Up to 36 months.

• Disease control rate (DCR)

  Up to 24 months.

• Duration of response (DoR)

  Up to 24 months.

• Progression-free survival (PFS)

  Up to 24 months.

• Overall survival (OS)

  Up to 3 years.

Study Arms (1)

Phase Ib (Dose exploration phase) Phase II (Proof-of-concept phase)

EXPERIMENTAL

Treatment cycles are set at 28 days, with investigational product administration continuing until disease progression or meeting other treatment discontinuation criteria.

Drug: HS-10516 + Lenvatinib

Interventions

HS-10516 + Lenvatinib DRUG

Administered orally.

Phase Ib (Dose exploration phase) Phase II (Proof-of-concept phase)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 after receiving ≥1 prior line of systemic therapy in the advanced setting.
• Patients have at least one target lesion according to RECEST 1.1. The requirements for target lesions are: measurable lesions without local treatment such as irradiation, or with definite progress after local treatment, with the longest diameter ≥ 10 mm in the baseline period (in case of lymph nodes, the shortest axis ≥ 15 mm is required). Patients with only brain and/or bone lesions as target lesions will not be included.
• ECOG performance status was 0-1 and did not deteriorate in the previous 2 weeks.
• Estimated life expectancy greater than (\>) 12 weeks.
• Reproductive-age women agree to use adequate contraception and cannot breastfeed while participating in this study and for a period of 12 months after the last dose. Likewise, men also consent to use adequate contraceptive method within the same time limit.
• Females must have the evidence of non-childbearing potential
• Sign informed consent form.

You may not qualify if:

• Prior or Current Treatments:
• Previous or current use of hypoxia-inducible factor inhibitors.
• Previous or current use of lenvatinib.
• Use of Chinese herbal medicine with antitumor indications within 2 weeks prior to the first dose or requirement for such treatment during the study.
• Administration of cytotoxic chemotherapy or other systemic antitumor therapies (e.g., endocrine therapy, molecular targeted therapy) within 2 weeks or 5 half-lives (whichever is shorter) prior to the first dose, or requirement for such treatments during the study.
• Use of large-molecule antitumor drugs within 4 weeks prior to the first dose or requirement for such treatment during the study.
• Use of CYP2C19 strong inhibitors/inducers or narrow therapeutic index sensitive substrates within 7 days prior to the first dose, or requirement for continued use during the study.
• Local radiotherapy (except brain radiotherapy; see Criterion 6) within 2 weeks prior to the first dose, or \>30% bone marrow irradiation/large-field radiotherapy within 4 weeks prior to the first dose.
• Major surgery (e.g., craniotomy, thoracotomy, laparotomy; Grade 3/4 per Chinese Medical Technical Clinical Application Regulations) within 4 weeks prior to the first dose.
• Participation in other interventional clinical trials within 4 weeks prior to the first dose or within 5 half-lives of investigational drugs (whichever is longer).
• Resting pulse oximetry \<92% at screening.
• Severe pulmonary dysfunction requiring intermittent/long-term oxygen therapy.
• Unresolved Grade \>1 toxicities from prior anti-tumor therapy (per CTCAE v5.0).
• History of second primary malignancy.
• Known or suspected active CNS metastases/leptomeningeal disease.

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Interventions

lenvatinib

Central Study Contacts

Jun Guo

CONTACT

010-88196358; guoj307@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 1, 2025
• Study Start: July 10, 2025
• Primary Completion (Estimated): July 10, 2027
• Study Completion (Estimated): July 10, 2028
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

CN (1)