Last updated: January 22, 2022
Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Overall Status: Active - Recruiting
Phase
1
Condition
Neoplasms
Treatment
N/AClinical Study ID
NCT05125523
HB1901-CSP-001
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age 18-75 years (inclusive), no gender limitation.
- Patients must have a histologically or cytologically confirmed advanced or metastatictumor for which no effective standard therapy is available, or have failed or beenintolerant to standard therapies.
- At least one measurable lesion per RECIST version 1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2.
- Life expectancy of ≥3 months.
- Suitable organs and hematopoietic function should be available. Laboratory testsduring screening should meet the appropriate criteria.
- Signed informed consent form.
Exclusion
Exclusion Criteria:
- Prior anticancer treatment or participation in another clinical study within 4 weeks (or 5 half-lives of the treated drug, whichever is longer) prior to the first dose ofstudy drugs.
- Patients who have undergone major surgery within 4 weeks prior to starting studytreatment, or who have not fully recovered from previous surgery.
- Unresolved toxicities from prior therapy greater than Grade 1 as per CommonTerminology Criteria for Adverse Events (CTCAE) (except alopecia or any other toxicitywithout safety risks as judged by the investigator).
- History of serious cardiovascular disease.
- Central nervous system metastasis or meningeal metastasis with clinical symptoms, orother evidence that the patient's central nervous system metastasis or meningealmetastasis has not been controlled, and the investigator judges it to be unsuitablefor inclusion.
- Known prior hypersensitivity to study drugs or any component in their formulations.
- Prior treatment with any mTOR inhibitor.
- Has received a live or live-attenuated virus vaccine within 30 days prior to consent.
- Uncontrollable active infection (CTCAE v5.0 ≥grade 2).
- Use of strong inhibitors and inducers of CYP3A4 within 2 weeks prior to receiving thefirst dose of study drug and still need to continue using this class of drug.
- History of autoimmune diseases, immunodeficiency, including HIV positive, or otheracquired, congenital immunodeficiency, or organ transplant history.
- HBsAg-positive with HBV viral load (VL) ≥1000 IU/mL; Hepatitis C Virus (HCV)-positive;Anti-treponema pallidum positive.
- Women of child-bearing potential, or men whose partners are women of childbearing age,have not agree to use highly effective methods of contraception during dosing and for 6 months after study drug discontinuation; female patients has a positive serumpregnancy test within 7 days prior to receiving the first dose of study medication;lactating female.
- Has history of other serious diseases judged by the investigator, which will threatenthe safety of patients or interfere the study compliance, or other reasons are notsuitable for participating in the study.
Study Design
Total Participants: 264
Study Start date:
December 28, 2021
Estimated Completion Date:
November 30, 2024
Study Description
Connect with a study center
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin 300060
ChinaActive - Recruiting

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