Clinical trial · Interventional
An Exploratory Study of Individualized Neo-antigen mRNA Cancer Vaccine InnoPCV in Advanced Solid Tumor Treatment
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
NCT06497010CI-TRIAL-00089199recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biological: InnoPCV | Drug | — | UNRESOLVED |
| Biological: PD-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose Escalation
- description
- 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
- interventionNames
- Drug: Biological: PD-1
- Drug: Biological: InnoPCV
Primary outcomes (1)
- measure
- Recommended Phase 2 Dose (RP2D)
- timeFrame
- Baseline through 90 days after last InnoPCV dose
Secondary outcomes (6)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.