HS-10502 combination treatment for advanced solid tumors
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10502 Combination Treatment in Subjects With Advanced Solid Tumors
This study will test whether the oral drug HS-10502, given with other cancer medicines, is safe and can help people with advanced solid tumors such as recurrent ovarian cancer, HER2‑negative or triple‑negative breast cancer, and advanced prostate cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 157 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Jiangsu Hansoh Pharmaceutical Co., Ltd. Industry-sponsored |
| Drugs / interventions | chemotherapy, Bevacizumab, Apatinib |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06769425 on ClinicalTrials.gov |
What this trial studies
This is a Phase I, multicenter, open‑label trial with a dose‑escalation (Phase Ia) and dose‑expansion (Phase Ib) design testing oral HS‑10502 combined with a range of anticancer agents. Phase Ia will use dose escalation to define safety, tolerability, pharmacokinetics, and the maximum tolerable or applicable dose of HS‑10502 in combination with agents such as enzalutamide, rezvilutamide, abiraterone, HS‑20093, apatinib, HS‑20089, platinum chemotherapy, bevacizumab, nab‑paclitaxel, docetaxel, and irinotecan. Phase Ib will open selected cohorts based on Phase Ia data (including recurrent ovarian cancer, HER2‑negative and TNBC, advanced prostate cancer, and HRD‑positive gynecologic cancers) to determine recommended Phase II doses for each population. Safety is monitored each treatment cycle with PK sampling during treatment and efficacy assessments every six weeks until objective progression or study end.
Who should consider this trial
Good fit: Adults (≥18) with pathologically confirmed advanced solid tumors who have at least one measurable lesion, ECOG performance status 0–1, life expectancy of at least 12 weeks, and who can comply with clinic visits and contraception requirements are the intended candidates.
Not a fit: Patients with poor performance status (ECOG ≥2), significant organ dysfunction or uncontrolled comorbidities, pregnant or breastfeeding individuals, or those unable to adhere to the monitoring schedule may not benefit or may be ineligible.
Why it matters
Potential benefit: If successful, HS‑10502 combinations could offer a new targeted oral option that improves disease control for some patients with PARP‑sensitive advanced tumors.
How similar studies have performed: Other PARP inhibitors such as olaparib and niraparib have demonstrated benefit in BRCA‑mutated and HRD‑positive ovarian and breast cancers, but HS‑10502 as a PARP1‑selective agent in these multi‑drug combinations is novel and unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Presence of active infectious diseases such as hepatitis B, hepatitis C, tuberculosis, syphilis, or human immunodeficiency virus infection, etc. * Current hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Class B or more severe cirrhosis. * Any moderate or severe lung diseases that may interfere with the detection and treatment of drug-related pulmonary toxicity or may seriously affect respiratory function. * History of severe neurological or psychiatric disorder. * Pregnant or breast-feeding women or women who intend to become pregnant during the study. * Attenuated live vaccination within 4 weeks prior to the first dose. * Subjects with autoimmune disease that is active or is likely to recur. * Subjects with gastrointestinal fistula, visceral fistula, gastrointestinal perforation, or abdominal abscess, or with symptoms/signs of intestinal obstruction within 6 months prior to the first dose of study drug. * Subjects unlikely to comply with study procedures, restrictions and requirement as determined by the investigator. * Subjects with any condition that jeopardizes the safety of the patient or interferes with the assessment of the study, as judged by the investigator.
Where this trial is running
Shanghai, Shanghai Municipality
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Xi Yan
- Email: yanx1@hspharm.com
- Phone: 18721195312
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.