Advanced Solid Tumors
Conditions
Brief summary
This research is designed to determine if HSK39775 is safe, tolerable, and has anti-cancer activity in patients with advanced solid tumors.
Interventions
DRUGHSK39775 Monotherapy
HSK39775 will be administered orally once daily
Sponsors
Xizang Haisco Pharmaceutical Co., Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Elimination half-life [t1/2] | At predefined intervals throughout the treatment period(approximately 12 weeks) |
| Overall Response Rate (ORR) per RECIST V1.1 | From Screening to confirmed progressive disease or date of death from any cause, whichever came first[approximately 1 year] |
| Progression Free Survival | From Screening to confirmed progressive disease or date of death from any cause, whichever came first[approximately 1 year] |
| Maximum Plasma Concentration [Cmax] | At predefined intervals throughout the treatment period(approximately 12 weeks) |
| Disease Control Rate | From Screening to confirmed progressive disease or date of death from any cause, whichever came first[approximately 1 year] |
| Best percentage change in target lesion | From Screening to confirmed progressive disease or date of death from any cause, whichever came first[approximately 1 year] |
| Time To Response | From Screening to confirmed progressive disease or date of death from any cause, whichever came first[approximately 1 year] |
| Area Under Curve[AUC] | At predefined intervals throughout the treatment period(approximately 12 weeks) |
| Time to maximum observed concentration [Tmax] | At predefined intervals throughout the treatment period(approximately 12 weeks) |
Countries
China
Contacts
Primary ContactYong Cao
Outcome results
None listed