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This is a phase I/II non-randomized, open-label, single-arm, multicenter study to evaluate the Safety and Efficacy of C019199 Plus Sintilimab in Participants With Advanced Solid Tumors.
Phase I will determine and confirm the maximum tolerated dose(MTD) and recommended phase II dose(RP2D) for C019199 in combination with 200 milligrams (mg) ( intravenous[IV], every 3 weeks [Q3W]) Sintilimab in patients with advanced Solid tumors.
Phase II will evaluate the safety and efficacy of the combination of C019199 and Sintilimab in selected solid tumors at the RP2D from Phase I.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C019199 plus Sintilimab | Experimental | Patients with selected tumors will received oral C019199 at a starting dose of 100mg once daily in combination with intravenous Sintilimab 200mg every 3 weeks ( Q3W ) on a 21-day treatment cycle until disease progression, development of unacceptable toxicity, or withdrawal of consent . |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C019199 | Drug | The C019199 will be taken orally, once a day |
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| Measure | Description | Time Frame |
|---|---|---|
| Dose-Limiting Toxicity (DLT) | Dose-limiting toxicity (DLT) refers to a drug-related toxicity during treatment with the drug, the severity of which is clinically unacceptable, limiting the further escalation of drug dose. | Cycle 1 (Cycle length=21 days) |
| Objective Response Rate (ORR) Based on iRECIST | ORR was defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) for target and non-target lesions. | From date of enrollment until the date of first documented progression or death |
| Progression-free Survival (PFS) after administration | Progression-free Survival (PFS) is defined as the time from the date of first dose of the study drug to the first documented disease progression (according to iRECIST ) or death (due to any cause), whichever occurs first. | From date of enrollment until the date of first documented progression or death |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events( TEAEs )and Serious Adverse Events (SAEs) | A TEAE was defined as an adverse event (AE) that emerged during the time from the first dose of study drug to 28 days following the last dose of study drug,which does not necessarily have a causal relationship with the treatment. A Serious AE is any untoward medical occurrence that at any dose: resulted in death; was life threatening (that is, the participant was at immediate risk of death from the AE as it occurred; this does not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death) required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria |
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Inclusion Criteria:
Participants are eligible to be included in the study only if all of the following criteria apply:
Exclusion Criteria:
Subjects meeting any of the following criteria must be excluded from this study:
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| Name | Affiliation | Role |
|---|---|---|
| FENG YE | The First Affiliated Hospital of Xiamen University | Principal Investigator |
| YONGCHANG ZHANG | Hunan Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Xiamen University | Xiamen | Fujian | China | |||
| Hunan Cancer Hospital |
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| ID | Term |
|---|---|
| C000632826 | sintilimab |
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DRUG: C019199
The C019199 will be taken orally, once a day
DRUG: Sintilimab
Sintilimab will be administrated with intravenous infusion, 200mg, every 3 weeks.
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| Sintilimab | Drug | Sintilimab will be administrated with intravenous infusion, 200mg, every 3 weeks. |
|
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| From the first dose until 28 days after the last dose |
| Cmax | Maximum Plasma Concentration | Cycle 1 Day 1; Cycle 1 Day 21 |
| AUC(0-t): | Area under the concentration-time curve (AUC) | Cycle 1 Day 1; Cycle 1 Day 21 |
| T1/2 | Terminal Half-life | Cycle 1 Day 1; Cycle 1 Day 21 |
| Disease Control Rate (DCR) after administration | Disease Control Rate (DCR) is defined as the proportion of patients with complete response, partial response and stable disease. | From date of enrollment until the date of first documented progression or death |
| Duration of Remission (DoR) after administration | Duration of Remission (DoR) is defined as the time from the first documentation of remission (PR or better) to the first documented disease progression evidence (according to iRECIST ) of the responders (who achieve PR or better response).se). | From date of enrollment until the date of first documented progression or death |
| Overall Survival (OS) after administration | OS is defined as the time from the date of study treatment to the date of death due to any cause . | The time from the date of enrollment until death |
| Changsha |
| Hunan |
| China |