Study of HS-10516 Combination Therapy in Patients With Advanced Renal Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJiangsu Hansoh Pharmaceutical Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
HS-10516 + Lenvatinib
DrugAdministered orally.
Treatment groups
104 Participants
are divided into 1 treatment groupGroup A: Phase Ib (Dose exploration phase) Phase II (Proof-of-concept phase)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Up to 3 months2
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.
Time frame
Up to 12 months.Secondary outcomes
1
Incidence and severity of treatment-emergent adverse events
Incidence of treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Time frame
Up to 36 months.2
Disease control rate (DCR)
The percentage of patients who have achieved complete response, partial response, and stable disease, according to response evaluation criteria in solid tumors (RECIST) 1.1 by investigator's assessment.
Time frame
Up to 24 months.3
Duration of response (DoR)
The time from complete or partial response to disease progression or death, according to response evaluation criteria in solid tumors (RECIST) 1.1 by investigator's assessment.
Time frame
Up to 24 months.4
Progression-free survival (PFS)
Progression free survival is defined as the duration of time from study entry to time of progression, death, or is censored at date of last disease assessment.
Time frame
Up to 24 months.Sponsors and contacts
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Source ClinicalTrials.gov