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).
18-75 years, male or female.
Histologically/cytologically or clinically confirmed advanced unresectable protocol-specified solid malignancies.
Participants with Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
Life expectation >= 12weeks.
Not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or better from the adverse events (except for alopecia, vitiligo, neurotoxicity, hypothyroidism hormone replacement therapy) caused by therapy administered within 4 weeks before the first dose of PD-1.
Participants with a history of (non-study tumor) malignancy (except for skin squamous cell carcinoma and basal cell carcinoma, in situ cervical or breast carcinoma) within 3 years before the first dose of PD-1.
Participation in a study of an investigational agent or using an investigational device within 30 days before the first dose of PD-1.
Previously received any adoptive cell therapy (including but not limited to tumor-infiltrating lymphocyte TILs, chimeric antigen receptor T cells (CAR-T) and T cell receptor chimeric T cells (TCR-T)), therapeutic tumor vaccines, etc.
Sequential
Biological: PD-1
DrugIntravenous (IV) infusion
Biological: InnoPCV
DrugIntramuscular (IM) injection
Recommended Phase 2 Dose (RP2D)
Number of Participants with Adverse Events
Neoantigen-specific T cell Response rate
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).
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).
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The Affiliated Hospital Of Guizhou Medical University
Lead sponsor
Innovac Therapeutics
Collaborator
