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| Name | Class |
|---|---|
| Innovac Therapeutics | INDUSTRY |
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This is an open-label, prospective, exploratory clinical study, which is divided into two phases: dose escalation phase (Phase Ia) and expansion phase (Phase Ib). After completing the dose-escalation phase (Stage Ia) (5-11 patients), the investigator will select the dose group (RP2D) based on safety, tolerability, and preliminary immune-related characteristics and efficacy data, and choose 2-3 advanced solid tumors to enter the expansion phase (Stage Ib).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation | Experimental | Part A (PD-1 Run-in): Participants will receive either tislelizumab (200 mg, IV Q3W) or sintilimab (200 mg, IV Q3W) for a lead-in period of one to three cycles. Part B( InnoPCV in Combination with PD-1): Participants will commence up to nine cycles of combination therapy, consisting of InnoPCV (0.06 - 1 mg, intramuscularly, every three weeks) in conjunction with the anti-PD-1 antibody (200 mg, intravenous infusion, every three weeks). Part C (PD-1 maintenance treatment) Participants will continue with maintenance therapy using either tislelizumab (200 mg, IV Q3W) or sintilimab (200 mg, IV Q3W) until disease progression or unacceptable toxicity observed |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biological: PD-1 | Drug | Intravenous (IV) infusion |
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| Biological: InnoPCV |
| Measure | Description | Time Frame |
|---|---|---|
| Recommended Phase 2 Dose (RP2D) | Baseline through 90 days after last InnoPCV dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events | Baseline through 90 days after last tislelizumab or sintilimab dose | |
| Neoantigen-specific T cell Response rate | Baseline through 26 weeks after last InnoPCV dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shengfa Su, MD,PhD | Contact | +86-13608550432 | sushengfa2005@163.com | |
| Bing Lu, MD | Contact | +86-13809432527 | lbgymaaaa@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Shengfa Su, MD,PhD | The Affiliated Hospital Of Guizhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Guizhou Medical University | Recruiting | Guiyang | China/Guizhou | China |
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| Drug |
Intramuscular (IM) injection |
|
| Objective Response Rate (ORR): Number of Participants with Tumor Response (Partial or Complete) | ORR is defined as the proportion of participants whose best overall response is complete response (CR) or partial response (PR). | Baseline through disease progression by Response Evaluation Criteria of Solid Tumors Version 1.1 (RECIST 1.1), start of new anti-cancer therapy, withdrawal of consent, death and last safety follow-up visit (up to approximately 2 years) |
| Duration of Response (DoR) | DoR is defined as time from first tumor response (partial or complete) until either radiological disease progression, clinical/symptomatic disease progression or death (whichever is sooner). | Baseline through disease progression by Response Evaluation Criteria of Solid Tumors Version 1.1 (RECIST 1.1), start of new anti-cancer therapy, withdrawal of consent, death and last safety follow-up visit (up to approximately 2 years) |
| Progression Free Survival (PFS) | PFS is defined as time between the date of first dose of pembrolizumab and the date of either radiological disease progression, clinical/symptomatic disease progression or death (whichever is sooner). | From baseline to disease progression by Response Evaluation Criteria of Solid Tumors Version 1.1 (RECIST 1.1) or death (up to approximately 2 years) |
| Overall Survival (OS) | OS is defined as time between the date of the first dose of study drug and the date of death due to any cause. | From baseline to approximately 2 years |