Solid tumor
Conditions
Interventions
Phase Ia: experimental group:BPSC for oral dose escalation
Phase Ib: experimental group:BPSC for oral dose expansion
Sponsors
Affiliated hangzhou first people's hospital, zhejiang university school of medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Willing and able to comply with the contraindications and restrictions specified in this protocol, and the subject voluntarily participates and signs a written informed consent form; 2.Age >= 18 years old, regardless of gender; 3.Patients with advanced solid tumors; 4.Applicable to Phase Ia study: Patients with solid tumors who have progressed after receiving established therapies, and refuse other anti-tumor treatments or cannot tolerate anti-tumor therapies; 5.Applicable to Phase Ib study: Patients with solid tumors who have received previous treatment; 6.Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0~3 (see Appendix 3); 7.Expected survival period >= 3 months; 8.Eligible patients of childbearing potential must agree to use reliable contraceptive methods (hormonal, barrier method or abstinence) with their partners during the trial and for at least 100 days after the last dose: For patients of childbearing age, the blood pregnancy test within 14 days before drug administration must be negative;
Exclusion criteria
Exclusion criteria: 1.Patients who have received the following previous anti-tumor treatments before the first administration of the study drug:? (1).? Received targeted therapy, investigational drug therapy, or invasive investigational medical devices within 14 days or at least 5 half-lives (whichever is longer);? (2).Used monoclonal antibody for the treatment of solid tumors within 14 days;? (3).Received cytotoxic therapy within 14 days;? (4).Received immunomodulator therapy within 7 days;? (5).Received radiotherapy within 14 days (except for low-dose palliative radiotherapy [10~30Gy]);? Received traditional Chinese medicine preparations related to anti-tumor treatment within 14 days. 2. Vaccinated with live attenuated vaccine within 4 weeks before the first administration of the study drug, or expected to receive live attenuated vaccine during the study period; 3. Toxicities from previous anti-tumor treatments have not recovered to baseline or = 5% according to standard classification), Waldenström macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein [M protein], and skin changes), or primary amyloid light-chain amyloidosis; 8.Patients with a history of other malignant tumors within 5 years before signing the informed consent form; 9. Known allergic reaction, hypersensitivity, or intolerance to PIC-carotene or its excipients. 10. Pulmonary impairment requiring continuous oxygen therapy to maintain adequate blood oxygen saturation levels; 11.The following cardiac diseases: New York Heart Association (NYHA) Class ? or ? congestive heart failure; myocardial infarction or coronary artery bypass grafting within = 6 months before enrollment; history of clinically significant ventricular arrhythmia or unexplained syncope; history of severe non-ischemic cardiomyopathy; 12. Any severe underlying diseases, such as: (1). Patients with active hepatitis B virus (HBV-DNA >= 1×10^3 copies/mL or HBV-DNA > 200 IU/mL), active hepatitis C virus (HCV) infection, or positive human immunodeficiency virus (HIV) serology; (2). Active autoimmune disease or documented history of autoimmune disease, excluding vitiligo, resolved childhood atopic dermatitis, and previous Graves' disease (patients with normal thyroid function based on clinical symptoms and laboratory tests before the first administration); (3). Underlying diseases that are not conducive to the patient receiving or tolerating the planned treatment at the r
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase Ia: Dose-Limiting Toxicity (DLT), Maximum Tolerated Dose (MTD), Recommended Phase 2 Dose (RP2D);Phase Ia: adverse events;Phase Ib:ORR (Overall Response Rate) , DOR (Duration of Response) , PFS (Progression-Free Survival) , OS (Overall Survival); | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase Ia:preliminary efficacy;Phase Ib: evaluate the incidence and severity of adverse events;Phase Ib:Duration of Response (DOR), Disease Control Rate (DCR), Progression-Free Survival (PFS), 6-month and 12-month PFS rates, Time to Response (TTR), rates of Partial Response (PR) or Complete Response (CR; | — |
Countries
China
Contacts
Public ContactXinyu Qian
Hangzhou First People's Hospital
Outcome results
None listed