A Phase 1 interventional study of TMV Vaccine and Toripalimab-tpzi in Squamous Cell Carcinoma of Head and Neck, Squamous Cell Carcinoma of Head and Neck (SCCHN) and HNSCC, sponsored by Metaclipse Therapeutics Corporation. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Metaclipse Therapeutics Corporation · Phase 1, Interventional, and Treatment
The goal of this clinical trial is to learn if an experimental, personalized cancer vaccine called TMV vaccine is safe and to find the best dose to study in future trials. The study includes adults with head and neck squamous cell carcinoma that has come back in or near the same area after earlier treatment, and who are planning to have surgery to remove it. The study will also test the vaccine together with toripalimab-tpzi, an approved immunotherapy drug.
The TMV vaccine is made from each participant's own tumor tissue. Small particles taken from the surface of the tumor cells have 2 immune-boosting proteins added to them, to help the immune system recognize and attack the cancer.
The main questions it aims to answer are:
The study has 2 parts.
In Part 1 (Phase 1a), participants will:
The first participants will receive the lowest dose. Later groups will receive higher doses only if the lower dose is found to be safe.
In Part 2 (Phase 1b), participants whose tumors test positive for a marker called PD-L1 will:
Researchers will also study blood and tumor samples to learn how the immune system responds to the vaccine.
This is a first-in-human, single-center, open-label Phase 1 study of an autologous tumor membrane vesicle (TMV) vaccine, alone and in combination with toripalimab-tpzi, in adults with loco-regionally recurrent head and neck squamous cell carcinoma (HNSCC) who are candidates for salvage surgery.
The TMV vaccine is prepared from each participant's resected or biopsied tumor tissue. Tumor membrane vesicles are modified by protein transfer to display the immunostimulatory molecules IL-12 and B7-1 through glycosylphosphatidylinositol (GPI) anchors, so that tumor antigens and immune-stimulating signals are delivered together at the vaccination site.
Phase 1a is a dose escalation of TMV vaccine monotherapy given as adjuvant therapy after salvage surgery. Three dose levels (0.25 mg, 0.5 mg, and 1.0 mg) are administered intradermally every 2 weeks for 3 doses. Up to 6 participants are enrolled at each dose level, and enrollment of the first 2 participants at each dose level is staggered by at least 28 days. Safety and immune stimulating activity are reviewed together to identify the optimal biological dose (OBD).
Phase 1b evaluates the TMV vaccine at the OBD in combination with toripalimab-tpzi in participants with PD-L1-positive tumors, using a combined neoadjuvant and post-operative adjuvant approach. Participants receive 2 neoadjuvant vaccine doses (every 2 weeks) and up to 2 doses of toripalimab-tpzi (every 3 weeks) before surgery, followed by 1 adjuvant vaccine dose and toripalimab-tpzi every 3 weeks for up to 1 year or until disease progression.
Participants are followed for survival for up to 3 years after treatment initiation.
2,018 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.
This study's planned enrollment of 30 is below the median of 48 across 1,653 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Browse Squamous Cell Carcinoma of Head and Neck studies →This is the only study on the registry with Metaclipse Therapeutics Corporation as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive TMV vaccine 0.25 mg by intradermal injection every 2 weeks for 3 doses (Weeks 0, 2, and 4) as adjuvant therapy after salvage surgery.
Biological: TMV Vaccine
Participants receive TMV vaccine 0.5 mg by intradermal injection every 2 weeks for 3 doses (Weeks 0, 2, and 4) as adjuvant therapy after salvage surgery.
Biological: TMV Vaccine
Participants receive TMV vaccine 1.0 mg by intradermal injection every 2 weeks for 3 doses (Weeks 0, 2, and 4) as adjuvant therapy after salvage surgery.
Biological: TMV Vaccine
Participants with PD-L1-positive tumors (CPS of 1 or higher) receive TMV vaccine at the optimal biological dose identified in Phase 1a, combined with toripalimab-tpzi. Before salvage surgery (neoadjuvant): TMV vaccine by intradermal injection every 2 weeks for 2 doses and toripalimab-tpzi 240 mg IV every 3 weeks for up to 2 doses. After surgery (adjuvant): 1 dose of TMV vaccine 3 weeks after surgery and toripalimab-tpzi 240 mg IV every 3 weeks for up to 1 year or until disease progression.
Biological: TMV Vaccine · Biological: Toripalimab-tpzi
Autologous, personalized tumor membrane vesicle (TMV) vaccine prepared from the participant's own tumor tissue, collected at salvage surgery (Phase 1a) or by biopsy (Phase 1b). Tumor membrane vesicles are modified by protein transfer to display the immunostimulatory molecules IL-12 and B7-1 through glycosylphosphatidylinositol (GPI) anchors. Administered by intradermal injection at dose levels of 0.25 mg, 0.5 mg, or 1.0 mg in Phase 1a, and at the optimal biological dose identified in Phase 1a for Phase 1b.
Also known as: Tumor Membrane Vesicle Vaccine, MTC-Vaccine-P, Membrex
Anti-PD-1 monoclonal antibody administered at 240 mg by intravenous infusion every 3 weeks, for up to 2 doses before salvage surgery and then for up to 1 year after surgery or until disease progression (Phase 1b only).
Also known as: LOQTORZI, JS001
Number of Participants With Dose-Limiting Toxicities (DLTs) in Phase 1a
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.
Time frame: From first dose through 3 weeks after the last vaccine dose (7 weeks)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Phase 1a
TEAEs and SAEs graded by severity per NCI CTCAE v6.0, reported by dose level.
Time frame: Frame: From first dose through 30 days after the last vaccine dose (approximately 8 weeks)
Recommended Phase 2 Dose (RP2D) of TMV Vaccine Alone
RP2D of TMV vaccine monotherapy, selected based on the totality of safety, tolerability, and immunogenicity data across Phase 1a dose levels.
Time frame: From first dose through 3 weeks after the last vaccine dose (7 weeks)
Number of Participants With Dose-Limiting Toxicities (DLTs) in Phase 1b
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.
Time frame: 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)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Phase 1b
TEAEs and SAEs graded by severity per NCI CTCAE v5.0.
Time frame: From first dose through 30 days after the last dose of study treatment (up to approximately 15 months)
Number of Participants With Immune-Related Adverse Events (irAEs) Attributable to Toripalimab-tpzi in Phase 1b
Immune-related adverse events attributed to toripalimab-tpzi, graded by severity per NCI CTCAE v5.0.
Time frame: From first dose through 30 days after the last dose of study treatment (up to approximately 15 months)
Recommended Phase 2 Dose (RP2D) of TMV Vaccine Plus Toripalimab-tpzi
RP2D of TMV vaccine in combination with toripalimab-tpzi, selected based on the totality of safety, tolerability, and immunogenicity data.
Time frame: 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)
Change From Baseline in T Cell Activation and Phenotype in Peripheral Blood
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).
Time frame: 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)
Change From Baseline in Plasma Cytokine and Chemokine Levels
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).
Time frame: 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)
Change in Percentage of Viable Tumor Cells From Baseline Biopsy to Surgical Resection in Phase 1b
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.
Time frame: From pre-treatment biopsy to surgical resection (approximately 10 weeks)
Major Pathologic Response (MPR) Rate in Phase 1b
Percentage of participants with 10% or fewer viable tumor cells in the resected specimen after neoadjuvant TMV vaccine plus toripalimab-tpzi.
Time frame: At surgical resection (approximately 10 weeks after biopsy)
Pathologic Complete Response (pCR) Rate in Phase 1b
Percentage of participants with no viable tumor cells (0%) in the resected specimen after neoadjuvant TMV vaccine plus toripalimab-tpzi.
Time frame: At surgical resection (approximately 10 weeks after biopsy)
Objective Response Rate (ORR) per RECIST v1.1 in Phase 1b
Percentage of participants with a complete or partial response per RECIST v1.1 on the restaging scan before surgery.
Time frame: At pre-surgical restaging after neoadjuvant treatment (approximately 6 weeks after first dose)
Disease Control Rate (DCR) per RECIST v1.1 in Phase 1b
Percentage of participants with a complete response, partial response, or stable disease per RECIST v1.1 on the restaging scan before surgery.
Time frame: At pre-surgical restaging after neoadjuvant treatment (approximately 6 weeks after first dose)
Progression-Free Survival (PFS)
Time from treatment initiation to first documented disease recurrence or death from any cause, in participants receiving TMV vaccine alone (Phase 1a) or TMV vaccine plus toripalimab-tpzi (Phase 1b).
Time frame: Up to 3 years
Overall Survival (OS)
Time from treatment initiation to death from any cause, in participants receiving TMV vaccine alone (Phase 1a) or TMV vaccine plus toripalimab-tpzi (Phase 1b).
Time frame: Up to 3 years
Correlation Between Tumor PD-L1 Combined Positive Score (CPS) and Immune Stimulating Activity
Tumor PD-L1 expression measured as combined positive score (CPS) by immunohistochemistry (22C3) on paraffin-embedded tumor sections. Correlation (Spearman coefficient) with each immune stimulating activity measure, reported separately: (1) neoantigen-specific T cell response in PBMCs (spot-forming units per 10\^6 PBMCs by IFN-γ ELISpot) and (2) change in CD8+ tumor-infiltrating lymphocyte density (cells/mm² by IHC), in participants receiving TMV vaccine alone or with toripalimab-tpzi.
Time frame: From baseline through end of treatment (up to approximately 15 months)
Correlation Between Baseline CD8+ Tumor-Infiltrating Lymphocyte (TIL) Density and Immune Stimulating Activity
CD8+ TIL density (cells/mm²) determined by immunohistochemistry on paraffin-embedded tumor sections. Correlation (Spearman coefficient) with neoantigen-specific T cell response, in participants receiving TMV vaccine alone or with toripalimab-tpzi.
Time frame: From baseline through end of treatment (up to approximately 15 months)
Correlation of Tumor Cellularity With TMV Vaccine Yield
Tumor cellularity determined by histological scoring, correlated with the total yield of TMV vaccine produced from the tumor tissue, along with immunogenicity and clinical response.
Time frame: At tumor tissue collection and vaccine production (baseline)
Tumor Mutational Burden (TMB)
TMB (mutations per megabase) by next-generation sequencing (NGS) of DNA from tumor tissue, with matched PBMC samples as germline reference.
Time frame: Baseline (tumor tissue collected at salvage surgery in Phase 1a or at pre-treatment biopsy in Phase 1b, with matched PBMCs)
Number of Predicted Neoantigens per Participant
Number of predicted neoantigens identified by NGS (whole exome and RNA sequencing) of matched tumor tissue and PBMC samples.
Time frame: Baseline (tumor tissue collected at salvage surgery in Phase 1a or at pre-treatment biopsy in Phase 1b, with matched PBMCs)
Plan to share: No — There is no plan to share individual participant data with other researchers. Study results may be published in aggregate in peer-reviewed journals.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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