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This research is designed to determine if HSK39775 is safe, tolerable, and has anti-cancer activity in patients with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation | Experimental | Dose Escalation:Participants will receive escalating doses of HSK39775 |
|
| Cohort Expansion | Experimental | Cohort Expansion:Participants will receive HSK39775 at the identified RP2D |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSK39775 Monotherapy | Drug | HSK39775 will be administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| AE/SAE | Safety data | From time of informed consent to 28 days post last dose or start of other anti-cancer therapies |
| DLT | Safety data | From the start of first dose to the end of Cycle1(each cycle is 28 days) |
| MTD/MAD | Safety data | From the start of first dose to the end of Cycle1(each cycle is 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration [Cmax] | At predefined intervals throughout the treatment period(approximately 12 weeks) | |
| Area Under Curve[AUC] | At predefined intervals throughout the treatment period(approximately 12 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yong Cao | Contact | 028-67258840 | caoyong@haisco.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| Time to maximum observed concentration [Tmax] | At predefined intervals throughout the treatment period(approximately 12 weeks) |
| 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] |
| Time To Response | From Screening to confirmed progressive disease or date of death from any cause, whichever came first[approximately 1 year] |
| 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] |