HS-10502 Combination Treatment in Patients With Advanced Solid Tumors
HS-10502
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10502 Combination Treatment in Subjects With Advanced Solid Tumors
1 other identifier
interventional
157
1 country
1
Brief Summary
HS-10502 is a PARP1-specific selective inhibitor. The purpose if this study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of HS-10502 Combination Treatment in subjects with advanced solid tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 7, 2025
CompletedFirst Posted
Study publicly available on registry
January 10, 2025
CompletedStudy Start
First participant enrolled
May 7, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 7, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
ExpectedJune 24, 2025
June 1, 2025
1 year
January 7, 2025
June 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Maximum tolerated dose (MTD) of HS-10502（Stage 1：Dose escalating stage）
MTD is defined as the previous dose level at which 2 or more out of 2-6 subjects experienced a DLT.
Cycle 1 (21 days)
Maximum applicable dose (MAD) of HS-10502（Stage 1：Dose escalating stage）
MAD is defined as follows: a) based on PK data, it is anticipated that at this dose level, the dose-exposure plateau has been reached, b) based on existing safety data, it is judged that dose escalation following this dose level will have a large safety risk or subject intolerance, or c) based on the PK-PD model, it suggested that the optimal target concentration of safety and efficacy has been explored.
Cycle 1 (21days)
Efficacy of HS-10502: Objective response rate (ORR)（Stage 2： Dose expansion stage）
ORR is defined as the proportion of participants with BOR of confirmed CR or confirmed PR per RECIST v1.1 (applicable for all solid tumors except prostate cancer) or per RECIST v1.1 and PCWG3 (for prostate cancer only).
From the date of first dose until the date of disease progression or withdrawal from study, approximately 2 years
Secondary Outcomes (18)
Incidence and severity of treatment-emergent adverse events
From Cycle 1 Day 1 (C1D1) until 21 days after the final dose. A cycle is 21days.
PK parameters: The maximum observed concentration (Cmax) of HS-10502
Cycle 1 Day 1 (each cycle is 21 days)
PK parameters: time to Cmax (Tmax) of HS-10502
Cycle 1 Day 1 (each cycle is 21 days)
PK parameters: area under the concentration-time curve from time 0 to time t of last measurable concentration (AUC0-t) of HS-10502.
Cycle 1 Day 1 (each cycle is 21 days)
PK parameters: Maximum plasma concentration at steady state (Css, max) of HS-10502
Cycle 2 Day 1 (each cycle is 21 days)
- +13 more secondary outcomes
Study Arms (7)
Cohort 1
EXPERIMENTALAdvanced prostate cancer
Cohort 2
EXPERIMENTALAdvanced prostate cancer or solid tumor
Cohort 3
EXPERIMENTALAdvanced HER2-negative breast cancer or recurrent ovarian cancer
Cohort 4
EXPERIMENTALRecurrent ovarian cancer
Cohort 5
EXPERIMENTALPlatinum-sensitive recurrent ovarian cancer
Cohort 6
EXPERIMENTALAdvanced gastric cancer or solid tumor
Cohort 7
EXPERIMENTALHRD positive advanced ovarian cancer, fallopian tube cancer or primary peritoneal cancer
Interventions
HS-10502 + nab-paclitaxel or Docetaxel or Irinotecan
Eligibility Criteria
You may qualify if:
- Males or females aged 18 years or older (≥18 years).
- Patients diagnosed with pathologically confirmed advanced solid tumors.
- Subjects have at least one target lesion as assessed per the RECIST 1.1.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 1 and no deterioration within 2 weeks before the first dose.
- Have a life expectancy of at least 12 weeks.
- Female subjects of childbearing potential are willing to take appropriate contraceptive measures and should not breastfeed from signing the informed consent until 6 months after the last dose; male subjects must agree to use barrier contraception (i.e. condoms) from signing the informed consent to 6 months after the last dose.
- Female subjects must have a negative pregnancy test within 7 days prior to the first dose (for subjects with tumor related abnormal elevation of human chorionic gonadotropin \[HCG\], an ultrasound of uterus and appendages should be performed within 7 days prior to the first dose to rule out pregnancy), or demonstrate no risk for pregnancy.
- Subject must be voluntarily enrolled in this clinical trial, be able to understand the study procedures and to sign written informed consent.
You may not qualify if:
- Have received or is currently receiving the following treatment: PARPi/B7-H4/B7-H3-targeted therapies;
- Have received or is currently receiving the following treatment: PARPi/B7-H4/B7-H3-targeted therapies;
- Have received any of cytotoxic chemotherapy drugs, investigational drugs, anti-tumor traditional Chinese medicines or other anti-tumor drugs within 14 days prior to the first dose of study drug; or need to continue these drugs during the study.
- Presence of Grade ≥ 2 toxicities as per Common Terminology Criteria for Adverse Events due to prior anti-tumor therapy.
- Presence of pleural/abdominal effusion requiring clinical intervention.
- Known history of other primary malignancy.
- Evidence of brain metastasis and/or cancerous meningitis
- Inadequate bone marrow reserve or hepatic/renal functions.
- Cardiological examination abnormality.
- Severe, uncontrolled or active cardiovascular disorders.
- Serious or poorly controlled diabetes.
- Serious or poorly controlled hypertension.
- Clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose of study treatment.
- Serious infections within 4 weeks prior to the first dose.
- Have received systemic glucocorticoid therapy for more than 7 days within 28 days prior to the first dose study treatment, or require chronic (≥ 7 days) use of systemic glucocorticoids during the study, or have other acquired, congenital immunodeficiency disorders, or a history of organ transplantation.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2025
First Posted
January 10, 2025
Study Start
May 7, 2025
Primary Completion
May 7, 2026
Study Completion (Estimated)
August 31, 2026
Last Updated
June 24, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share