Clinical trial NCT06497010: An Exploratory Study of Individualized Neo-antigen mRNA Cancer Vaccine InnoPCV in Advanced Solid Tumor Treatment
Official title: An Open Label, Prospective, Exploratory Study to Assess the Safety and Efficacy of Individualized Neo-antigen mRNA Cancer Vaccine InnoPCV in Combination With PD-1 in Participants With Advanced Solid Tumor
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Advanced Solid Tumor
Lead sponsor: The Affiliated Hospital Of Guizhou Medical University
Sponsor class: OTHER
Collaborators: name: Innovac Therapeutics
First posted: 2024-07-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* 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.
* Participants must have a formalin-fixed paraffin-embedded (FFPE) tumor sample available (for example, from their prior surgery) that is suitable for the next-generation sequencing (NGS) required for this study.
* Adequate organ function.
* Participants must agree to use adequate contraception from the first dose of study medication through 180 days after the last dose of study medication (male and female participants of childbearing potential).

Exclusion Criteria:

* 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.
* Participants received chemotherapy, radiotherapy (palliative radiotherapy is allowed), and immune activator (including but not limited to IL-2) and other antitumor therapy within 21 days before the first dose; Participants received Chinese herbal medicine within 2 weeks before the first dose of PD-1.
* Major surgery (excluding diagnostic biopsy) or significant trauma had not been fully recovered within 28 days before the first dose of PD-1.
* Participants received live attenuated vaccine within 28 days before starting study treatment or planned to receive live attenuated vaccine during the study and within 60 days after ending the study drug treatment.
* Active autoimmune disease or a documented history of autoimmune disease or the syndrome that requires systemic steroids or immunosuppressive agents, except vitiligo or resolved childhood asthma/atopy.
* Positive for Human Immunodeficiency Virus (HIV), Hepatitis B (HBV-DNA≥ 500IU/ml), or Hepatitis C virus (Hepatitis C Virus Ribonucleic Acid \[HCV RNA\] (qualitative) is detected).
* Previously identified hypersensitivity to components of the formulations used in this study.

Primary outcomes:
measure: Recommended Phase 2 Dose (RP2D)
timeFrame: Baseline through 90 days after last InnoPCV dose
Secondary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: Baseline through 90 days after last tislelizumab or sintilimab dose
measure: Neoantigen-specific T cell Response rate
timeFrame: Baseline through 26 weeks after last InnoPCV dose
measure: Objective Response Rate (ORR): Number of Participants with Tumor Response (Partial or Complete)
timeFrame: 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)
measure: Duration of Response (DoR)
timeFrame: 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)
measure: Progression Free Survival (PFS)
timeFrame: 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)
measure: Overall Survival (OS)
timeFrame: From baseline to approximately 2 years
Other outcomes:
Locations:
city: Guiyang
country: China
facility: The Affiliated Hospital of Guizhou Medical University
state: China/Guizhou
Study officials:
affiliation: The Affiliated Hospital Of Guizhou Medical University
name: Shengfa Su, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: