Advanced Solid TumorEarly Phase 1NCT06497010
An Exploratory Study of Individualized Neo-antigen mRNA Cancer Vaccine InnoPCV in Advanced Solid Tumor Treatment
A Early Phase 1 study testing Biological: PD-1 and Biological: InnoPCV in people with Advanced Solid Tumor, run by The Affiliated Hospital Of Guizhou Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- Biological: PD-1 and Biological: InnoPCV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 29 Aug 2024to Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Guizhou Medical University
Guiyang, China/Guizhou
Shengfa Su, MD, PhD, +86-13608550432, sushengfa2005@163.com
Bing Lu, MD, PhD, +86-13809432527, lbgymaaaa@163.com
About this study
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
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
- Advanced Solid Tumor
- Being tested
- Biological: PD-1, Biological: InnoPCV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological: PD-1Drug
Intravenous (IV) infusion
Biological: InnoPCVDrug
Intramuscular (IM) injection
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | 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 Receives: Drug: Biological: PD-1; Drug: Biological: InnoPCV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended Phase 2 Dose (RP2D)
Measured: Baseline through 90 days after last InnoPCV dose
Secondary outcomes (6)
Number of Participants with Adverse Events
Measured: Baseline through 90 days after last tislelizumab or sintilimab dose
Neoantigen-specific T cell Response rate
Measured: Baseline through 26 weeks after last InnoPCV dose
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).
Measured: 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)
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).
Measured: 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)
Progression Free Survival (PFS)
PFS is defined as time between the date of first dose of pembrolizumab and the date of either radiological disease progression, clinical/symptomatic disease progression or death (whichever is sooner).
Measured: 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)
Overall Survival (OS)
OS is defined as time between the date of the first dose of study drug and the date of death due to any cause.
Measured: From baseline to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start29 Aug 2024
- Primary completionJul 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital Of Guizhou Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Innovac Therapeutics
- Responsible party
- Principal investigator, Shengfa Su, The Affiliated Hospital Of Guizhou Medical University
- Investigators
- Shengfa Su, MD,PhD, Principal investigator, The Affiliated Hospital Of Guizhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497010
- Sponsor's protocol ID
- InnoPCV-001
- Status last verified
- Apr 2025
- First submitted
- 4 Jul 2024
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06497010
- Acronym / sponsor ID
- InnoPCV-001
- Conditions
- Advanced Solid Tumor
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Affiliated Hospital Of Guizhou Medical UniversityUniversity, hospital or other
- Collaborators
- Innovac Therapeutics
- Study start
- 29 Aug 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: Biological: PD-1, Drug: Biological: InnoPCVPart 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological: PD-1Intravenous (IV) infusion | Drug | Dose Escalation |
| Biological: InnoPCVIntramuscular (IM) injection | Drug | Dose Escalation |
Primary outcome
Recommended Phase 2 Dose (RP2D)
Time frame: Baseline through 90 days after last InnoPCV dose
6 secondary outcomes
Number of Participants with Adverse Events
Time frame: Baseline through 90 days after last tislelizumab or sintilimab dose
Neoantigen-specific T cell Response rate
Time frame: Baseline through 26 weeks after last InnoPCV dose
Objective Response Rate (ORR): Number of Participants with Tumor Response (Partial or Complete)
Time frame: 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)
Duration of Response (DoR)
Time frame: 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)
Progression Free Survival (PFS)
Time frame: 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)
Overall Survival (OS)
Time frame: From baseline to approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shengfa Su, MD,PhD principal investigator
The Affiliated Hospital Of Guizhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Biological: PD-1 and Biological: InnoPCV in people with Advanced Solid Tumor, run by The Affiliated Hospital Of Guizhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shengfa Su, MD,PhD (+86-13608550432, sushengfa2005@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommended Phase 2 Dose (RP2D) (time frame: Baseline through 90 days after last InnoPCV dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.