Advanced solid cancer
Conditions
Interventions
Single drug increasing cohort A0(Patients with locally advanced or metastatic breast cancer):All subjects in the dose escalation group received purinostat mesylate for injection intravenous infusion i
Single drug increasing cohort A0(Patients with advanced solid cancer):All subjects in the dose escalation group received purinostat mesylate for injection intravenous infusion in an ascending order of
The combination increased cohort A(advanced breast cancer):The intravenous infusion of purinostat Mesylate for Injection was administered in ascending order of 6.0 mg/m2, 8.4 mg/m2, 11.2 mg/m2, and 15
Sponsors
Sun Yat-sen Memorial Hospital,Sun Yat-sen University/West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: > =18 years old, and 21 days and < 26 days before the first dose of the study drug, the hormone level was required to be eligible), and the subjects were required to continue using such drugs during the study treatment; (2) tislelizumab plus cohort B (solid tumors) : Patients with cytologically or histologically confirmed, locally advanced or metastatic solid tumors who have failed standard treatment, who have no standard treatment options, or who are not currently suitable for standard treatment, are defined as follows for each tumor type: 1) Non-small cell lung cancer: a. Metastatic patients without driver mutations: disease progression or relapse after at least second-line therapy, including platinum-based chemotherapy; b. Patients whose tumors have driver mutations such as EGFR, ROS1, or ALK should have disease progression or relapse after failure of targeted therapies targeting these mutations after at least a second line of therapy, includin
Exclusion criteria
Exclusion criteria: 1. Known severe allergy to the investigational drug, concomitant drugs or any excipient (hydroxypropyl beta-cyclodextrin, arginine, methylamine, mannitol); 2. Currently or previously suffering from other malignancies (except for skin basal cell carcinoma or squamous cell carcinoma that have been fully treated and cervical intraepithelial carcinoma), unless radical treatment has been undergone and there is no evidence of recurrence or metastasis within the past 5 years; 3. Subjects with symptomatic central nervous system (CNS) metastasis or those requiring steroid treatment within 2 weeks before the first administration of the investigational drug, and without symptomatic CNS metastasis. Subjects with carcinomatous meningitis or periventricular leptomeningeal dissemination. 4. Patients whose previous anti-tumor treatment history meets the following conditions should be excluded: (1) Those who received mitomycin C or nitrosourea-based chemotherapy within 6 weeks before the first administration; (2) Those who received systemic anti-tumor treatment within 4 weeks before the first administration, such as chemotherapy, endocrine therapy, immunotherapy, biological therapy, etc.; (3) Those who received clinical trial drug treatment within 4 weeks before the first administration, or are currently participating in other clinical trials; (4) Those who received oral fluorouracil-based drugs or small molecule targeted drugs within 2 weeks before the first administration, or within the 5 half-life periods of the known drugs (whichever is longer); (5) Those who received local palliative radiotherapy within 2 weeks before the first administration; (6) Those who received Chinese herbal medicine or Chinese patent medicine with anti-tumor indications within 2 weeks before the first administration. Note: If the subject received different release periods of drug treatment simultaneously, the actual release period shall be executed according to the longer one. 5. Patients who have received HDAC inhibitors in the past; 6. Patients who have received any estrogen receptor degrading agents, including but not limited to fulvestrant, in the past, cannot be included in the cohort receiving combined treatment with fulvestrant; 7. Patients who have received anti-PD-1/PD-L1 antibody treatment cannot be included in the cohort receiving combined treatment with tislelizumab, unless they have benefited from the treatment in the advanced/metastatic stage* and are thus allowed to be included. *The definition of benefit after anti-PD-1/PD-L1 antibody treatment is as follows: (1) After receiving anti-PD-1/PD-L1 antibody monotherapy or combination therapy with targeted drugs or other immunotherapeutic agents, the best response as assessed by imaging is CR or PR; (2) After receiving anti-PD-1/PD-L1 antibody combined with chemotherapy, there is no imaging evidence suggesting disease progression within = 6 months after treatment. 8. For patients who had severe infections within 4 weeks before the first administration of the investigational product, or who required oral or intravenous antibiotics for active infections within the previous 2 weeks; 9. For patients who received blood transfusion, recombinant human thrombopoietin, recombinant human interleukin-11, erythropoietin, granulocyte colony-stimulating factor, etc. within 2 weeks before the first use of the study drug; 10. For breast cancer patients: those with symptomatic, metastatic, and at risk of developing life
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective remission rate;Disease control rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to response;Duration of response;Progression free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactHerui Yao
Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Outcome results
None listed