Actively Recruiting
A Clinical Study of Purinostat Mesylate for Injection in Patients With Advanced Solid Tumors
Led by Chengdu Zenitar Biomedical Technology Co., Ltd · Updated on 2025-04-10
132
Participants Needed
2
Research Sites
129 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Primary Objectives Phase Ib To evaluate the safety and tolerability of Purinostat Mesylate in combination therapy for advanced solid tumors; and to explore the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of Purinostat Mesylate in combination therapy in patients with advanced solid tumors. To determine the recommended Phase II dose (RP2D) of Purinostat Mesylate in combination therapy for advanced solid tumors. Phase IIa To further evaluate the preliminary efficacy of Purinostat Mesylate in combination therapy in patients with advanced solid tumors. Secondary Objectives Phase Ib To evaluate the safety and tolerability of Purinostat Mesylate Monotherapy for the treatment of advanced solid tumors; To evaluate the preliminary efficacy of Purinostat Mesylate in combination therapy in patients with advanced solid tumors; To evaluate the pharmacokinetic characteristics of Purinostat Mesylate in combination therapy for the treatment of advanced solid tumors. Phase IIa To further evaluate the safety and tolerability of Purinostat Mesylate in combination therapy for advanced solid tumors. To evaluate the pharmacokinetic characteristics of Purinostat Mesylate in combination therapy for advanced solid tumors. Exploratory Objectives To assess the pharmacodynamic characteristics in Purinostat Mesylate combination therapy for advanced solid tumors.
CONDITIONS
Official 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 tumor lesion as defined by RECIST 1.1 (except breast cancer patients with only bone metastases in dose-escalation phase)
- For monotherapy breast cancer cohort: confirmed advanced or metastatic breast cancer with no suitable standard treatment
- For monotherapy solid tumor cohort: confirmed advanced or metastatic solid tumors with no suitable standard treatment
- For combination with Fulvestrant (breast cancer cohort): confirmed ER-positive, PgR-positive or negative, non-HER2-positive breast cancer with progression after endocrine therapy
- For combination with Tislelizumab (solid tumor cohort): confirmed advanced solid tumors with progression after at least second-line treatment
- ECOG performance status of 0 or 1
- Life expectancy of at least 12 weeks
- Adequate organ function including specified blood counts, kidney, and liver function
- Willingness to participate and provide informed consent
- Resolved acute toxicities from previous treatments to baseline or Grade 1 or less (except alopecia)
You will not qualify if you...
- Known severe allergy to study drugs or their components
- History of other malignancies unless treated and no recurrence for 5 years
- Symptomatic or asymptomatic central nervous system metastases or meningeal carcinomatosis
- Recent anti-tumor treatments within specified washout periods
- Previous treatment with HDAC inhibitors
- Previous use of fulvestrant for the Fulvestrant cohort
- Previous anti-PD-1/PD-L1 therapy for the Tislelizumab cohort unless prior benefit
- Severe infection or active infection requiring antibiotics recently
- Recent use of certain blood or immune-boosting treatments
- Visceral crisis or inflammatory breast cancer for breast cancer patients
- Grade 3 or higher immune-related adverse events from prior immunotherapy
- Active or history of autoimmune diseases excluding manageable Type I diabetes or thyroiditis
- Recent use of systemic corticosteroids or immunosuppressants for Tislelizumab cohort
- Significant uncontrolled heart or brain vascular diseases
- Uncontrolled electrolyte imbalances affecting QTc interval
- Lung diseases causing impaired lung function
- Uncontrolled fluid buildup such as pleural effusion or ascites
- Recent major surgery or incomplete recovery from anesthesia
- Active hepatitis B or C infections or positive syphilis tests
- History of immunodeficiency including HIV or organ transplant
- Participation in another clinical trial recently
- Pregnancy, breastfeeding, or inability to use contraception
- Other severe medical or psychiatric conditions posing risk or interfering with study participation
AI-Screening
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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
CONTACT
Z
Zheng Jiang, bachelor
CONTACT
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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