Actively Recruiting
Multicenter, Dose-Escalation and Dose-Expansion, Single-Arm, Open-Label Phase I Trial to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TSL2109 Capsules in Advanced Solid Tumor Patients
Led by Tasly Pharmaceutical Group Co., Ltd · Updated on 2026-04-07
78
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating TSL2109, a new drug that targets specific proteins (CDK4/6 and DYRK2) involved in the growth of solid tumors. It is designed to work in cases where other treatments, like palbociclib and androgen receptor inhibitors, have stopped working. This drug aims to help patients with metastatic castration-resistant prostate cancer (mCRPC) and hormone receptor-positive, HER2-negative advanced breast cancer who have limited treatment options. The study is a Phase 1 trial focusing on safety, tolerability, and early signs of effectiveness. The study includes a Dose-Escalation Phase where participants receive increasing doses of TSL2109 capsules orally while fasting. Initial dosing involves a single dose followed by a 72-hour observation period. Subsequent treatment cycles last 28 days, with daily dosing for 3 weeks followed by a 1-week break. Dose levels may be adjusted if the drug is well tolerated and potentially beneficial. The Dose-Expansion Phase uses the same regimen to further evaluate the drug at doses up to the maximum tolerated dose (MTD). Participants will be monitored closely for tolerability and drug levels in their blood within 31 days after dosing. They will undergo tumor assessments based on standardized criteria, and treatment will continue until disease progression, unacceptable side effects, or the start of another cancer therapy. The study includes detailed observation of dose-limiting toxicities and allows dose adjustments to optimize treatment. Total participation length varies depending on individual responses and treatment continuation.
CONDITIONS
Brief Title
TSL2109 Capsules in Advanced Solid Tumor Patients: Safety, Tolerability, PK and Preliminary Efficacy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically or cytologically confirmed advanced solid tumors with no effective standard therapy or unsuitable for standard treatment
- Priority given to patients with metastatic castration-resistant prostate cancer (mCRPC) and HR+/HER2- advanced breast cancer
- At least one evaluable or measurable tumor lesion per RECIST Version 1.1
- Life expectancy of at least 3 months
- ECOG performance status score of 0 to 1
- For mCRPC: castration status with ongoing androgen deprivation therapy or history of bilateral orchiectomy; serum testosterone ≤1.7 nmol/L; disease progression documented by PSA or imaging criteria
- For HR+/HER2- breast cancer: confirmed HR-positive, HER2-negative status; prior exposure to CDK4/6 inhibitors
You will not qualify if you...
- Clinically symptomatic central nervous system or leptomeningeal metastases
- Diagnosis of another invasive cancer within the past 2 years, except certain skin or in situ cancers
- Significant gastrointestinal dysfunction affecting oral drug intake or absorption
- Tumor invasion of major blood vessels with bleeding risk
- Interstitial lung disease, pneumonitis, or pulmonary fibrosis
- History of deep vein thromboembolism
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 - Multiple 28-day cycles until disease progression or discontinuation
Participants receive TSL2109 capsules orally under fasting conditions once daily in 28-day cycles. The first cycle includes a 3-day initial dosing with 72-hour observation followed by 3 weeks of daily dosing and a 1-week treatment-free interval. Treatment continues until disease progression, intolerable toxicity, or initiation of new therapy.
1 initial dosing visit with 72-hour observation, then daily dosing with regular visits for safety and efficacy monitoring
Trial Site Locations
Total: 1 location
1
Shanghai Gaobo Cancer Hospital (China Pharmaceutical University)
Shanghai, Shanghai Municipality, China, 200003
Actively Recruiting
Research Team
R
Rui Liu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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