NCT05911464
Recruiting
Phase 1
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10386 in Participants With Advanced Solid Tumors
Jiangsu Hansoh Pharmaceutical Co., Ltd.1 site in 1 country248 target enrollmentStarted: March 2, 2023Last updated:
Overview
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Enrollment
- 248
- Locations
- 1
- Primary Endpoint
- Maximum Tolerated Dose (MTD) or Maximum Applicable Dose (MAD) (Dose Escalation Phase)
Overview
Brief Summary
The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and preliminary anti-tumor activity of HS-10386 in participants with advanced solid tumors who have failed prior treatments.
Detailed Description
This is a phase I open label, multicenter clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of HS-10386 in subjects with advanced solid tumors.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female, 18-75 years old.
- •Histologically or cytologically documented, incurable or metastatic solid tumors for which standard treatment either does not exist or has proven ineffective or unavailable or intolerable.
- •At least one measurable lesion per RECIST v1.
- •Willingness to provide fresh or archival tumor biopsy sample.
- •An Eastern Cooperative Oncology Group (ECOG) performance status equal to 0-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.
- •Willingness to use adequate contraceptive measures throughout the study.
- •Ability to comprehend and willingness to sign a written ICF for the study.
Exclusion Criteria
- •Treatment with any of the following:
- •Previous or current treatment with systemic immunotherapy.
- •Treatment with anticancer medications or investigational drugs within protocol-defined intervals prior to the first scheduled dose of HS-
- •Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 except for alopecia.
- •Known additional malignancy.
- •History or risk of autoimmune disease.
- •Known primary CNS malignancy or symptomatic CNS metastases. Patients with asymptomatic CNS metastases may be enrolled after consultation.
- •Inadequate bone marrow reserve or organ function.
- •Clinically significant cardiac disease.
- •Any evidence of severe or uncontrolled systemic diseases
Arms & Interventions
HS-10386
Experimental
Participants will receive HS-10386 once daily. The duration of each treatment cycle is 21 days.
Intervention: HS-10386 (Drug)
Outcomes
Primary Outcomes
Maximum Tolerated Dose (MTD) or Maximum Applicable Dose (MAD) (Dose Escalation Phase)
Time Frame: Up to 21 days from the first dose
MTD is defined as the dose level immediately below that at which 2 or more patients exhibit dose limiting toxicity. MAD is defined as the maximum administered dose, when MTD is not reached.
Objective Response Rate (ORR) defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (Dose Expansion Phase)
Time Frame: Every 6 weeks for the duration of study participation; estimated to be 12 months.
ORR is defined as the percentage of patients who have at least 1 response of CR or PR prior to any evidence of progression.
Secondary Outcomes
- Tmax of HS-10386(Approximately 1 month.)
- λz of HS-10386(Approximately 1 month.)
- The correlation between PD-L1 expression and efficacy of HS-10386(Approximately 3 years.)
- Incidence and Severity of Adverse Events (AEs)(From Informed consent until the end of the follow-up period which is defined as 28 days (+7 days) after study treatment is discontinued.)
- Cmax of HS-10386(Approximately 1 month.)
- AUC0-t of HS-10386(Approximately 1 month)
- CL/F of HS-10386(Approximately 1 month.)
- t1/2 of HS-10386(Approximately 1 month.)
- ORR defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (Dose Escalation Phase)(Every 6 weeks for the duration of study participation; estimated to be 12 months.)
- Disease Control Rate (DCR)(Every 6 weeks for the duration of study participation; estimated to be 12 months.)
- Duration of Response (DoR)(Every 6 weeks for the duration of study participation; estimated to be 12 months.)
- Progression-Free Survival (PFS)(Every 6 weeks for the duration of study participation; estimated to be 12 months.)
- Overall Survival (OS) (Dose Expansion Phase)(From the time of randomization to death due to any cause, approximately 3 years.)
Investigators
Study Sites (1)
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