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Trial Title:
An Exploratory Study of Individualized Neo-antigen mRNA Cancer Vaccine InnoPCV in Advanced Solid Tumor Treatment
NCT ID:
NCT06497010
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Tislelizumab
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Biological: Tislelizumab
Description:
Intravenous (IV) infusion
Arm group label:
Dose Escalation
Intervention type:
Drug
Intervention name:
Biological: InnoPCV
Description:
Intramuscular (IM) injection
Arm group label:
Dose Escalation
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).
Criteria for 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 at least one measurable lesion based on RECIST v1.1.
- 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.
- Participant 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 prior to the first dose of tislelizumab.
- 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 prior to the first dose of tislelizumab.
- Participation in a study of an investigational agent or using an investigational
device within 30 days prior to the first dose of tislelizumab.
- 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 prior to the first dose; Participants have received
Chinese herbal medicine within 2 weeks prior to the first dose of tislelizumab.
- Major surgery (excluding diagnostic biopsy) or significant trauma had not been fully
recovered within 28 days prior to the first dose of tislelizumab.
- 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 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Affiliated Hospital of Guizhou Medical University
Address:
City:
Guiyang
Country:
China
Status:
Recruiting
Contact:
Last name:
Shengfa Su, MD, PhD
Phone:
+86-13608550432
Email:
sushengfa2005@163.com
Contact backup:
Last name:
Bing Lu, MD, PhD
Phone:
+86-13809432527
Email:
lbgymaaaa@163.com
Start date:
August 2024
Completion date:
December 2026
Lead sponsor:
Agency:
The Affiliated Hospital Of Guizhou Medical University
Agency class:
Other
Collaborator:
Agency:
Innovac Therapeutics
Agency class:
Industry
Source:
The Affiliated Hospital Of Guizhou Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06497010
