Trial · NCT07898124
TMV Vaccine Alone or With Toripalimab-tpzi for Recurrent Head and Neck Squamous Cell Carcinoma
NCT07898124, Phase 1, Recruiting, Metaclipse Therapeutics Corporation
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. TMV Vaccine Alone or With Toripalimab-tpzi for Recurrent Head and Neck Squamous Cell Carcinoma. Trials, record NCT07898124. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07898124
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- TMV Vaccine Alone or With Toripalimab-tpzi for Recurrent Head and Neck Squamous Cell Carcinoma
- NCT number
- NCT07898124
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 30 participants, estimated
- Lead sponsor
- Metaclipse Therapeutics Corporation
- Conditions
- Squamous Cell Carcinoma of Head and Neck, Squamous Cell Carcinoma of Head and Neck (SCCHN), HNSCC, Neoplasm Recurrence, Local, Recurrent Head and Neck Squamous Cell Carcinoma
- Interventions
- TMV Vaccine, Toripalimab-tpzi
- First posted
- 2026-10-27
- Last updated
- 2026-10-27
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Dose-Limiting Toxicities (DLTs) in Phase 1a | From first dose through 3 weeks after the last vaccine dose (7 weeks) | A DLT is a TMV vaccine-related adverse event that is Grade 4 hematologic or Grade 3 or higher non-hematologic per NCI CTCAE v6.0, except Grade 3 injection site reactions adequately controlled with medical treatment. Reported by dose level. |
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Phase 1a | Frame: From first dose through 30 days after the last vaccine dose (approximately 8 weeks) | TEAEs and SAEs graded by severity per NCI CTCAE v6.0, reported by dose level. |
| Primary | Recommended Phase 2 Dose (RP2D) of TMV Vaccine Alone | From first dose through 3 weeks after the last vaccine dose (7 weeks) | RP2D of TMV vaccine monotherapy, selected based on the totality of safety, tolerability, and immunogenicity data across Phase 1a dose levels. |
| Primary | Number of Participants With Dose-Limiting Toxicities (DLTs) in Phase 1b | From first dose through 3 weeks after the last TMV vaccine dose or last toripalimab-tpzi dose, whichever is later (up to approximately 15 months) | A DLT is a TMV vaccine-related adverse event that is Grade 4 hematologic or Grade 3 or higher non-hematologic per NCI CTCAE v6.0, in participants receiving TMV vaccine plus toripalimab-tpzi. |
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Phase 1b | From first dose through 30 days after the last dose of study treatment (up to approximately 15 months) | TEAEs and SAEs graded by severity per NCI CTCAE v5.0. |
| Primary | Number of Participants With Immune-Related Adverse Events (irAEs) Attributable to Toripalimab-tpzi in Phase 1b | From first dose through 30 days after the last dose of study treatment (up to approximately 15 months) | Immune-related adverse events attributed to toripalimab-tpzi, graded by severity per NCI CTCAE v5.0. |
| Primary | Recommended Phase 2 Dose (RP2D) of TMV Vaccine Plus Toripalimab-tpzi | From first dose through 3 weeks after the last TMV vaccine dose or last toripalimab-tpzi dose, whichever is later (up to approximately 15 months) | RP2D of TMV vaccine in combination with toripalimab-tpzi, selected based on the totality of safety, tolerability, and immunogenicity data. |
| Secondary | Change From Baseline in T Cell Activation and Phenotype in Peripheral Blood | Before each TMV vaccine dose, and 24 hours and 7 to 9 days after each dose; also 2 weeks after the final dose in Phase 1a (Week 6) | Activation status and phenotype of T cell subsets in peripheral blood mononuclear cells (PBMCs), measured by flow cytometry, in participants receiving TMV vaccine alone (Phase 1a) or TMV vaccine plus toripalimab-tpzi (Phase 1b). |
| Secondary | Change From Baseline in Plasma Cytokine and Chemokine Levels | Before each TMV vaccine dose, and 24 hours and 7 to 9 days after each dose; also 2 weeks after the final dose in Phase 1a (Week 6) | Plasma cytokine and chemokine biomarkers measured in peripheral blood in participants receiving TMV vaccine alone (Phase 1a) or TMV vaccine plus toripalimab-tpzi (Phase 1b). |
| Secondary | Change in Percentage of Viable Tumor Cells From Baseline Biopsy to Surgical Resection in Phase 1b | From pre-treatment biopsy to surgical resection (approximately 10 weeks) | Pathologic response to neoadjuvant TMV vaccine plus toripalimab-tpzi, measured as the change in viable tumor cell percentage from the pre-treatment biopsy to the resected specimen. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07898124
GET https://conductscience.org/api/trials/v1/NCT07898124/registered?page=2