Actively Recruiting
An Exploratory Study of Individualized Neo-antigen mRNA Cancer Vaccine InnoPCV in Advanced Solid Tumor Treatment
Led by The Affiliated Hospital Of Guizhou Medical University · Updated on 2025-05-01
40
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
Sponsors
T
The Affiliated Hospital Of Guizhou Medical University
Lead Sponsor
I
Innovac Therapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
An Exploratory Study of Individualized Neo-antigen mRNA Cancer Vaccine InnoPCV in Advanced Solid Tumor Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, male or female
- Confirmed advanced unresectable solid malignancies by histology, cytology, or clinical diagnosis
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 12 weeks
- Availability of formalin-fixed paraffin-embedded (FFPE) tumor sample suitable for next-generation sequencing
- Adequate organ function
- Agreement to use effective contraception from the first dose until 180 days after last study medication dose for participants of childbearing potential
You will not qualify if you...
- Not recovered to CTCAE Grade 1 or better from adverse events caused by prior therapy within 4 weeks before first PD-1 dose, except alopecia, vitiligo, neurotoxicity, hypothyroidism on hormone replacement
- History of non-study tumor malignancy within 3 years before first PD-1 dose, except certain skin and cervical or breast carcinomas
- Participation in investigational agent or device study within 30 days before first PD-1 dose
- Previous adoptive cell therapy or therapeutic tumor vaccine
- Received chemotherapy, radiotherapy (except palliative), immune activators, or other antitumor therapy within 21 days before first PD-1 dose
- Received Chinese herbal medicine within 2 weeks before first PD-1 dose
- Major surgery or significant trauma not fully recovered within 28 days before first PD-1 dose
- Received live attenuated vaccine within 28 days before study treatment or planning to receive it during treatment and within 60 days after
- Active or history of autoimmune disease requiring systemic steroids or immunosuppressive agents, except vitiligo or resolved childhood asthma/atopy
- Positive for HIV, Hepatitis B with HBV-DNA ≥ 500IU/ml, or Hepatitis C virus
- Known hypersensitivity to components of study formulations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Affiliated Hospital of Guizhou Medical University
Guiyang, China/Guizhou, China
Actively Recruiting
Research Team
S
Shengfa Su, MD,PhD
CONTACT
B
Bing Lu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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