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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Intravenous (IV) infusion
Intramuscular (IM) injection
The Affiliated Hospital of Guizhou Medical University
Guiyang, China/Guizhou, China
RECRUITINGRecommended Phase 2 Dose (RP2D)
Time frame: Baseline through 90 days after last InnoPCV dose
Number of Participants with Adverse Events
Time frame: Baseline through 90 days after last tislelizumab or sintilimab dose
Neoantigen-specific T cell Response rate
Time frame: Baseline through 26 weeks after last InnoPCV dose
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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: From baseline to approximately 2 years
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