Actively Recruiting
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10502 Combination Treatment in Subjects With Advanced Solid Tumors
Led by Jiangsu Hansoh Pharmaceutical Co., Ltd. · Updated on 2025-06-24
157
Participants Needed
1
Research Sites
16 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and effectiveness of HS-10502 combination treatment in adults with advanced solid tumors. This phase I, open-label trial includes patients with various advanced cancers such as ovarian, breast, prostate, and gastric cancers. The study aims to find the best dose and understand how HS-10502 works with other anticancer drugs. The trial has two phases: phase Ia is a dose-escalation stage to determine the maximum tolerated or applicable dose of HS-10502 combined with other cancer treatments like Enzalutamide, Abiraterone, Apatinib, and chemotherapy agents. Phase Ib expands to seven groups targeting specific cancers based on phase Ia results to find the recommended dose for further studies. Treatment cycles last 2 or 3 weeks, with evaluations continuing through multiple cycles and follow-up periods. Participants will undergo safety checks each treatment cycle up to cycle 16, then every 6 weeks afterward until 30 to 90 days post-treatment. Pharmacokinetics will be studied during screening and treatment. Effectiveness is assessed every 6 weeks until disease progression or withdrawal, with survival followed every 12 weeks after treatment ends. The study expects to last about two years for disease evaluations and up to four years for overall survival tracking.
CONDITIONS
Brief Title
HS-10502 Combination Treatment in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 18 years or older (≥18 years).
- Diagnosed with pathologically confirmed advanced solid tumors.
- Have at least one target lesion assessed by RECIST 1.1.
- Eastern Cooperative Oncology Group Performance Status score of 0 to 1 with no worsening within 2 weeks before treatment.
- Life expectancy of at least 12 weeks.
- Females of childbearing potential must agree to use contraception and not breastfeed from consent until 6 months after last dose; males must agree to use barrier contraception during the same period.
- Negative pregnancy test within 7 days before first dose or no risk of pregnancy.
- Voluntarily enrolled and able to understand study procedures and sign informed consent.
You will not qualify if you...
- Received or currently receiving PARPi/B7-H4/B7-H3-targeted therapies.
- Received cytotoxic chemotherapy, investigational drugs, anti-tumor traditional Chinese medicines, or other anti-tumor drugs within 14 days prior to first dose or need to continue these drugs during the study.
- Presence of Grade 2 or higher toxicities from prior anti-tumor therapy.
- Presence of pleural or abdominal effusion requiring clinical intervention.
- Known history of other primary malignancy.
- Evidence of brain metastasis or cancerous meningitis.
- Inadequate bone marrow, liver, or kidney function.
- Abnormal cardiological examination.
- Severe, uncontrolled, or active cardiovascular disorders.
- Serious or poorly controlled diabetes or hypertension.
- Significant bleeding symptoms or tendency within 1 month before first dose.
- Serious infections within 4 weeks before first dose.
- Systemic glucocorticoid therapy longer than 7 days within 28 days before first dose or need for chronic use during study.
- Acquired or congenital immunodeficiency disorders or history of organ transplantation.
- Active infectious diseases like hepatitis B, C, tuberculosis, syphilis, or HIV.
- Current hepatic encephalopathy, hepatorenal syndrome, or severe cirrhosis.
- Moderate or severe lung diseases affecting respiratory function or drug toxicity detection.
- History of severe neurological or psychiatric disorders.
- Pregnant or breastfeeding women or women intending pregnancy during study.
- Attenuated live vaccination within 4 weeks before first dose.
- Active or likely recurrent autoimmune disease.
- Gastrointestinal fistula, perforation, abscess, or intestinal obstruction symptoms within 6 months before first dose.
- Unlikely to comply with study procedures or safety concerns as judged by investigator.
- Any condition jeopardizing patient safety or study assessment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Duration - Repeated 21-day cycles until disease progression or withdrawal, up to approximately 2 years
Participants receive oral HS-10502 combination treatment with other antitumor agents in repeated cycles to evaluate safety, tolerability, pharmacokinetics, and efficacy.
Visits every 3 weeks for up to 16 cycles, then every 6 weeks thereafter
Duration - Up to 4 years after last dose
Participants are monitored for safety and survival after treatment ends.
Survival follow-up visits every 12 weeks
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
X
Xi Yan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
7
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