Actively Recruiting
A Clinical Study of JS105 in Combination With Other Anti-tumor Therapies in Patients With Advanced Solid Tumors
Led by Risen (Suzhou) Pharma Tech Co., Ltd. · Updated on 2025-07-25
306
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating JS105 combined with other anti-tumor therapies in patients with advanced solid tumors in this open-label, multicenter Phase Ib/II clinical trial. The study aims to assess the safety, tolerability, pharmacokinetics, and early effectiveness of JS105 in combination with various treatments across two stages: dose escalation and dose expansion. This research focuses on patients with different types of advanced solid tumors including breast, endometrial, cervical, ovarian, and gynecologic cancers. The study includes multiple treatment groups where JS105 is given orally daily along with other anti-tumor drugs such as Fulvestrant (intramuscular), Dalpiciclib (oral), Toripalimab (intravenous infusion), Paclitaxel (intravenous infusion), Fluzoparib (oral), Pyrotinib (oral), and Capecitabine (oral). Each combination varies by study arm and involves specific dosing schedules like cycles of 28 days or infusions every 3 weeks. Participants receive these treatments during the dose-escalation and dose-expansion phases. Participants will be closely monitored with assessments including dose-limiting toxicity, maximum tolerated dose, and adverse events over up to two years. The study tracks objective response rates, disease control, survival, and detailed pharmacokinetic parameters of JS105 and combination drugs at set intervals. Safety evaluations and detailed follow-up visits help researchers understand how the treatments affect patients over time and inform future therapy use.
CONDITIONS
Brief 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...
- Understand and voluntarily sign the informed consent form
- Age between 18 and 75 years, male or female
- For Arms A and B: confirmed recurrent/metastatic HR-positive, HER2-negative breast cancer with specific hormone receptor and HER2 status criteria
- For Arm C: confirmed recurrent/metastatic endometrial and cervical cancer with disease progression after at least one systemic therapy
- For Group D: confirmed recurrent/metastatic triple-negative breast cancer or advanced gynecologic tumors with prior therapy progression
- For Arm E: confirmed recurrent/metastatic triple-negative breast cancer or ovarian, fallopian tube, or primary peritoneal cancer with prior therapy progression
- For Arm F: confirmed recurrent/metastatic HER2-positive breast cancer with prior anti-HER2 therapy progression
- For Group G: newly diagnosed or recurrent/metastatic triple-negative breast cancer without prior advanced disease systemic therapy
- Agree to provide tumor tissue and blood samples for PIK3CA mutation testing
- Resolved acute toxicities from prior treatments to Grade 0-1 except certain exceptions
- At least one measurable or non-measurable lesion meeting RECIST v1.1 criteria
- ECOG performance status 0 or 1
- Expected survival of at least 12 weeks
- Ability to swallow oral medications without altering dosage form
- Adequate vital organ functions and stable anticoagulant therapy if applicable
- Negative pregnancy test for females of childbearing potential and agreement to use effective contraception during and after treatment
You will not qualify if you...
- Prior treatment with PI3K/AKT/mTOR inhibitors or fulvestrant and other SERDs for specific groups
- Known hypersensitivity to JS105 or combination drugs
- Recent major surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, or biological therapy within defined timeframes before study drug
- Use of other investigational drugs or live vaccines within 4 weeks before study drug
- Use of strong CYP3A4 inhibitors or inducers within 7 days before study drug
- Long-term use of high-dose corticosteroids or immunosuppressive drugs within 2 weeks before study drug
- Previous allogeneic bone marrow or solid organ transplantation
- Other malignancies within 5 years except certain treated cancers
- Untreated or symptomatic central nervous system metastases not stable for at least 3 months
- Uncontrolled pleural, pericardial, or ascites effusions
- Uncontrollable serious medical conditions including severe cardiovascular disease, pancreatitis, uncontrolled diabetes, active infection, and severe lung disease
- Gastrointestinal conditions affecting swallowing or absorption
- Known HIV positive or active hepatitis B or C with specific exceptions
- Pregnant, lactating, or intending to become pregnant during the study
- Any other significant disease or condition affecting compliance or consent ability
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.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive JS105 orally once daily combined with other anti-tumor therapies specific to their assigned treatment arm. Treatment cycles last 28 days with varying administration schedules depending on the combination drugs.
Visits every 3 to 4 weeks depending on treatment cycle
Duration - Up to 2 years
Participants are monitored for safety and treatment outcomes including adverse events and survival for up to 2 years after treatment.
Periodic visits for up to 2 years
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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