Actively Recruiting
A Clinical Study of JS105 in Combination With Other Anti-tumor Therapies in Patients With Solid Tumors
Led by Risen (Suzhou) Pharma Tech Co., Ltd. · Updated on 2025-07-25
306
Participants Needed
1
Research Sites
163 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is an open-label, multicenter, Phase Ib/II clinical study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of JS105 in combination with other anti-tumor therapies in patients with advanced solid tumors. Patients will be enrolled in two stages: a dose-escalation stage and a dose-expansion stage.
CONDITIONS
Official Title
A Clinical Study of JS105 in Combination With Other Anti-tumor Therapies in Patients With Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and voluntarily sign the informed consent form
- Age between 18 and 75 years, male or female
- Patients with confirmed recurrent/metastatic HR-positive and HER2-negative breast cancer meeting specific receptor and menopausal status criteria (Arms A and B)
- Patients with confirmed recurrent/metastatic endometrial and cervical cancer with disease progression after at least one systemic therapy (Arm C)
- Patients with recurrent/metastatic triple-negative breast cancer or advanced gynecologic tumors with disease progression after at least one systemic therapy (Group D)
- Patients with confirmed recurrent/metastatic triple-negative breast cancer or epithelial ovarian, fallopian tube, or primary peritoneal cancer with disease progression after at least one systemic therapy (Arm E)
- Patients with confirmed recurrent/metastatic HER2-positive breast cancer with disease progression after at least one anti-HER2 therapy (Arm F)
- Patients with first-diagnosed stage IV or recurrent/metastatic triple-negative breast cancer without prior systemic therapy for advanced disease (Group G)
- Agree to provide tumor tissue and blood samples for PIK3CA mutation testing
- All prior acute toxicities resolved to Grade 0-1 except certain conditions
- At least one measurable or certain bone lesions for Phase II
- ECOG performance status of 0 or 1
- Expected survival of at least 12 weeks
- Ability to swallow oral medications without altering dosage form
- Vital organ functions within required limits
- Negative serum HCG test and use of effective contraception for females of childbearing potential
You will not qualify if you...
- Prior treatment with PI3K/AKT/mTOR inhibitors, fulvestrant, or other SERDs (for certain groups)
- Known allergy to JS105 or combination drug components
- Recent major surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, biological therapy, investigational drugs, or live vaccines within specified time frames
- Use of strong CYP3A4 inhibitors or inducers within 7 days
- Need for high-dose systemic corticosteroids or immunosuppressive drugs within 2 weeks
- Previous allogeneic bone marrow or solid organ transplantation
- Other malignancies within 5 years except certain treated cancers
- Symptomatic or untreated central nervous system metastases requiring treatment
- Uncontrolled or frequently recurring pleural, pericardial, or ascites effusions
- Uncontrollable diseases including pancreatitis, diabetes, active infection, severe cardiovascular or lung diseases, gastrointestinal issues affecting drug intake
- Known HIV positive or active hepatitis B or C with exceptions
- Pregnant, lactating, or intending to become pregnant females
- Any other significant disease or condition that may affect compliance or informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Henan Provincial Cancer Hospital
Zhengzhou, Henan, China, 450000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
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