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An Open, Multicenter Phase Ib/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Purinostat Mesylate Injection in Combination Therapy for Advanced Solid Tumors
Led by Chengdu Zenitar Biomedical Technology Co., Ltd · Updated on 2025-04-10
132
Participants Needed
2
Research Sites
26 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating Purinostat Mesylate in combination therapies for patients with advanced solid tumors, including breast cancer and other solid tumor types. The study aims to assess safety, tolerability, dose limits, and preliminary effectiveness of Purinostat Mesylate given with other treatments like fulvestrant or tislelizumab. The trial includes both Phase Ib dose-escalation and Phase IIa expansion phases to better understand how these therapies work in patients without other standard treatment options. Participants receive different doses of Purinostat Mesylate by intravenous infusion, either alone or combined with fulvestrant or tislelizumab, given in cycles of 21 or 28 days depending on the group. The study includes several groups: breast cancer patients receiving Purinostat Mesylate alone or with fulvestrant, and patients with various advanced solid tumors receiving Purinostat Mesylate alone or with tislelizumab. Dose escalation occurs gradually with monitoring for side effects and safety to find the best dose for further study. During the trial, participants undergo regular assessments including tumor measurements and safety tests to track treatment effects and side effects up to 96 weeks. Researchers will evaluate outcomes such as the rate of tumor remission, disease control, survival times, and duration of response. Participants also have their organ function and laboratory values monitored, with ongoing safety follow-up throughout the study period. The trial spans from initial treatment up to nearly two years to gather detailed data on treatment impact and tolerability.
CONDITIONS
Brief Title
A Clinical Study of Purinostat Mesylate for Injection in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, any gender
- At least one measurable lesion by RECIST 1.1, except some breast cancer patients with only bone metastases
- Histologically or cytologically confirmed locally advanced or metastatic breast cancer or solid tumors failing standard treatment or unsuitable for standard options
- For breast cancer combination group: hormone receptor-positive, HER2-negative disease with prior endocrine therapy and no surgical option
- ECOG performance status 0 or 1
- Life expectancy of at least 12 weeks
- Adequate organ function including blood counts, liver and kidney function
- Resolved acute toxicities from previous treatments to grade 1 or baseline
- Willingness to participate and provide informed consent
You will not qualify if you...
- Allergy to study drugs or their components
- Other malignancies within 5 years except certain treated skin or cervical cancers
- Symptomatic or untreated central nervous system metastases
- Recent chemotherapy, immunotherapy, radiotherapy, or investigational drug within specified washout periods
- Prior treatment with HDAC inhibitors
- Prior fulvestrant use for breast cancer combination group
- Prior anti-PD-1/PD-L1 therapy for tislelizumab combination group unless previously benefited
- Active infections or recent severe infections
- Recent blood transfusions or growth factor treatments
- Life-threatening breast cancer conditions or inflammatory breast cancer
- Severe immune-related adverse events from prior immunotherapy
- Active or history of autoimmune diseases with exceptions
- Recent systemic corticosteroid or immunosuppressive use
- Significant cardiovascular or cerebrovascular diseases
- Uncontrolled electrolyte imbalances
- Lung diseases affecting function
- Uncontrolled fluid buildup
- Recent major surgery or lack of recovery from minor surgery
- Active hepatitis B or C infection
- Immunodeficiency or organ transplant history
- Participation in other clinical trials within 4 weeks
- Pregnant or breastfeeding women or those not using contraception
- Other severe medical or psychiatric conditions affecting safety or study results
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 - Up to 96 weeks
Participants receive Purinostat Mesylate, with or without fulvestrant or tislelizumab, according to their assigned cohort. Dosing schedules vary by cohort, with treatment cycles lasting 21 or 28 days and repeated dosing continuing up to 96 weeks or until discontinuation.
Multiple visits per cycle depending on cohort: For Cohort A0, infusions on days 1, 4, 15, and 18 of each 28-day cycle; Cohort A, infusions on days 1, 4, 15, and 18 plus fulvestrant injections on days 1 and 15 of first cycle and day 1 of subsequent cycles; Cohort B0, infusions on days 1, 4, 8, and 11 of each 21-day cycle; Cohort B, infusions on days 1, 4, and 8 plus tislelizumab infusion on day 1 of each 21-day cycle.
Trial Site Locations
Total: 2 locations
1
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guanzhou, Guangzhou, China, 510000
Actively Recruiting
2
West China hospital of Sichuan university
Chengdu, Sichuan, China, 610000
Actively Recruiting
Research Team
L
Liangkun Sun, bachelor
Z
Zheng Jiang, bachelor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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