HSK39775 Monotherapy: HSK39775 will be administered orally once daily
Study summary
This research is designed to determine if HSK39775 is safe, tolerable, and has anti-cancer activity in patients with advanced solid tumors.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Age 18 years or older at screening
2. Histological or cytological confirmation of advanced malignancy, have failed or intolerant to the standard-of-care treatment or no standard therapy is recognized or standard therapy is unavailable
3. Eastern Cooperative Oncology Group performance status 0 or 1
4. Patients must have evaluable disease as defined
5. Life expectancy of ≥ 12 weeks
6. Adequate organ and bone marrow function per protocol
7. Female patients who are women of childbearing potential with confirmed of a negative pregnancy test within 7 days prior to the first dose and agreement to the use of effective contraceptive method at the same time during study treatment period and for up to 6 months after the last dose of study treatment. Male patients must be willing to use effective contraception during the study treatment period and for up to 6 months after the last dose of study treatment
8. Written informed consent must be obtained
Exclusion Criteria:
1. Known allergies to HSK39775 or its excipients
2. Prior anticancer treatment is ineligible per protocol
3. Subjects who have had continuous corticosteroids at a dose of \>10 mg prednisone/day or equivalent within 4 weeks prior to the first dose of study treatment
4. Subjects who have had live vaccine within 4 weeks prior the first dose of study treatment
5. Currently participating in a study of another investigational agent or device
6. Subjects who have had received another agent with same target
7. Subjects who have not recovered (to grade ≤1 or baseline) from toxicities related to prior therapies
8. Subjects who have had received drugs that may have drug-drug interaction potential within 4 weeks or 5 half-lives prior to the first dose of study treatment
9. Subjects who have had received major surgery within 4 weeks prior the first dose of study treatment
10. Central nervous system metastases associated with neurological symptoms
11. Active hepatitis B or hepatitis C infection
12. A history of immunodeficiency
13. Clinically relevant cardiovascular disease as delined by protocol
14. Inability to swallow the formulated product or impairment of GI function or disease that may significantly alter the absorption of study drug
15. A female patient who is pregnant or lactating
16. Other conditions, in investigator's opinion, not suitable to participate in the clinical study
Primary outcome measure(s)
AE/SAE — From time of informed consent to 28 days post last dose or start of other anti-cancer therapies Safety data
DLT — From the start of first dose to the end of Cycle1(each cycle is 28 days) Safety data
MTD/MAD — From the start of first dose to the end of Cycle1(each cycle is 28 days) Safety data
Trial sites (1)
Facility
City
Region
Status
Fundan University Shanghai Cancer Center
Shanghai
Shanghai Municipality
Recruiting
More Xizang Haisco Pharmaceutical Co., Ltd trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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