Advanced Solid TumorsPhase 1NCT06719362
A Clinical Trial to Evaluate the Safety, Tolerability and Clinical Efficacy of M3T01 Monotherapy and in Combination With Pembrolizumab and Other Systemic Therapies
A Phase 1 study testing M3T01, Pembrolizumab and Chemoradiation in people with Advanced Solid Tumors, run by Providence Health & Services at 1 site in United States.
Trial summary
Phase 1 first-in-human, open-label, dose-escalation (3 + 3), dose-expansion clinical trial to evaluate the safety, tolerability and preliminary clinical efficacy of M3T01 (fully human IgG4/kappa monoclonal antibody targeting FasL) in subjects with metastatic or unresectable solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- M3T01, Pembrolizumab and Chemoradiation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2025to Feb 2030
- Phase
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Life expectancy ≥ 12 weeks.
- Provision of written informed consent (see Section 16.1 and Appendix 18.5.5) for participation in the clinical trial.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-1 for subjects with solid tumors other than glioblastoma.
- Karnofsky Performance Status of ≥ 70% for subjects with glioblastoma.
- Tumor tissue from a surgical or core needle biopsy must be provided to the sponsor (fine needle aspirate or cytology specimens are not acceptable). Archival formalin fixed paraffin embedded (FFPE) tissue is acceptable. If archival tumor tissue is not available, a fresh tumor biopsy must be performed.
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- Subjects must have a tumor accessible for biopsy while on treatment. If the subject does not have a tumor that is safely accessible for biopsy, the subject may still participate in the clinical trial following authorization from the sponsor. NOTE: Subjects with glioblastoma are not required to have tumor accessible for biopsy and will not undergo a protocol specified biopsy on study.
- Eligible tumor types in Part 1 Dose Escalation will include subjects with histologically or cytologically confirmed metastatic or unresectable solid tumors who have developed disease progression following standard systemic therapy in the unresectable or metastatic setting. Subjects with cancers that harbor a molecularly defined oncogenic target for which an FDA approved therapy is available (including but not limited to EGFR, ROS1, ALK, BRAF, RET, NTRK, KRAS G12C, etc.) should have received this therapy.
- Measurable disease
- Subjects with solid tumors other than glioblastoma must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Subjects with glioblastoma: Part 1: must have measurable disease per Response Assessment in Neuro-Oncology (RANO 2.0); Part 2: measurable disease at baseline is not required as these subjects will have undergone maximal safe resection prior to enrollment.
- Adequate organ function as defined by the following:
- Absolute neutrophil count (ANC) ≥ 1.2 x 109/L.
- Hemoglobin ≥ 9.0 g/dL (without a blood transfusion 2 weeks prior to the hemoglobin measurement).
- Platelet count ≥ 100 x 109/L (without a platelet transfusion 2 weeks prior to the platelet measurement).
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN.
- Total bilirubin ≤ 1.5 x ULN (or ≤ 3 x ULN for subjects with Gilbert's syndrome).
- International normalized ratio (INR) ≤ 1.5 x ULN and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN (unless the subject is being treated with anticoagulant medication).
- Serum albumin ≥ 2.8 g/dL.
- Creatinine clearance (measured or calculated) ≥ 30 mL/min.
- Female subjects of reproductive potential who are sexually active with a male partner must:
- Have a negative serum beta-human chorionic gonadotropin (β-HCG) test within 3 days of cycle 1 day 1.
- Agree to use highly effective contraceptive measures (as defined in protocol) from the time of enrollment through 3 months after the last dose of study drug in the clinical trial.
- Female subjects are considered to be of non-reproductive potential if they: have been amenorrheic for greater than 1 year or have undergone surgical sterilization through tubal ligation, oophorectomy or hysterectomy.
- Male subjects with a female partner of reproductive potential must agree to use highly effective contraception (as defined in protocol) from the time of enrollment through 3 months after the last dose of study drug administration.
- Subjects must agree to not donate sperm or eggs (ova, oocytes) for the purpose of reproduction from the time of enrollment through 3 months after the last dose of study drug administration.
- Toxicities from prior anti-cancer therapy must have resolved to grade ≤ 1.
- Exceptions include vitiligo, endocrinopathies managed with hormone replacement therapy, alopecia, and grade 2 neuropathy or hearing loss.
Who cannot join
- Treatment with anticancer therapy within 14 days or 5 half-lives (whichever is shorter) of cycle 1 day 1. Palliative radiation therapy to a non-CNS metastasis is permitted if completed at least 14 days prior to cycle 1 day 1.
- History of other active malignancy that required treatment within 2 years of enrollment. Exceptions include the following:
- Early-stage/localized tumors that have received definitive/curative treatment and have low risk of recurrence (including but not limited to cutaneous squamous cell or basal cell carcinoma, in situ cervical or bladder cancer, and early-stage prostate cancer).
- Early-stage prostate cancer in which observation without treatment is recommended.
- Clinically significant cardiovascular conditions as defined by the following:
- New York Heart Association (NYHA) congestive heart failure class ≥ II.
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- Left ventricular ejection fraction ≤ 50%.
- Clinically significant cardiac arrhythmia requiring treatment within 3 months of enrollment. Subjects with cardiac arrhythmias on stable management for over 3 months prior to enrollment are permitted.
- Prolonged QTcF interval > 480 ms.
- Myocardial infarction, stroke, or pulmonary embolism within 3 months of enrollment.
- CNS metastases or leptomeningeal carcinomatosis (applicable to subjects with solid tumors other than glioblastoma). Subjects with brain metastases are eligible for participation if one of the following criteria are met:
- CNS metastases have been treated with surgical resection or radiation therapy and have remained stable for at least 4 weeks (repeat imaging required at least 4 weeks following resection or last radiation therapy) prior to cycle 1 day 1.
- The subject is neurologically asymptomatic and there are ≤ 4 CNS metastases no larger than 1 cm.
- Treatment with immunosuppressive medications.
- Treatment with corticosteroids greater than the equivalent of prednisone 10 mg/day within 2 weeks of cycle 1 day 1 is exclusionary. Exceptions include: Premedication with corticosteroids for iodine contrasted CT scans; Chronic use of ≤ 10 mg/day of prednisone (or equivalent). Topical, inhaled, and intra-articular corticosteroid use is allowed; Subjects with glioblastoma are permitted to be on ≤ 3 mg/day dexamethasone (or equivalent).
- History of severe pulmonary disease defined as either of the following:
- History of interstitial lung disease, non-infectious pneumonitis (including immune checkpoint inhibitor induced pneumonitis), or pulmonary fibrosis.
- Currently dependent on supplemental oxygen.
- History of allogeneic stem cell or solid organ transplantation.
- History of autoimmune disease that required systemic immunosuppressive therapy within 2 years of enrollment. Subjects with autoimmune diseases managed with hormone replacement or topical therapies are eligible.
- History of an immune-mediated adverse event from treatment with an immune checkpoint inhibitor that resulted in treatment discontinuation.
- Subjects who discontinued treatment with ipilimumab due to toxicity and subsequently tolerated treatment with an anti-PD-(L)1 inhibitor without treatment-limiting toxicity are eligible.
- History of severe hypersensitivity reaction (≥ grade 3) to infusion of a therapeutic monoclonal antibody.
- Any major surgery within 4 weeks of receiving the first dose of the investigational treatment.
- Women who are pregnant or breast feeding.
- Subjects with active (acute or chronic) bacterial, viral, or fungal infection at the time of enrollment are ineligible with the following exceptions:
- Subjects with human immunodeficiency virus (HIV) are eligible for participation if the following criteria are met: CD4+ T cell count ≥350 cells/µL, No history of AIDS-defining opportunistic infections within 12 months of enrollment, Subjects must be on antiretroviral therapy for at least 4 weeks and have an HIV viral load less than 400 copies/mL prior to enrollment.
- Subjects with chronic hepatitis B (HBV) who are on suppressive antiviral therapy prior to enrollment are eligible. Subjects with chronic HBV who are not eligible for treatment with suppressive antiviral therapy are ineligible.
- Subjects with a history of hepatitis C (HCV) infection who have completed curative antiviral treatment and have an HCV viral load below the limit of quantification are eligible.
- Ongoing drug or alcohol abuse at the time of enrollment.
- Any medical or psychiatric illness or social circumstance that could jeopardize compliance with the protocol directed treatment and safety assessments.
- Additional Exclusion Criteria Specific for the Part 2A - Newly Diagnosed MGMT Unmethylated Glioblastoma Cohort:
- Subjects with recurrent or secondary GBM.
- Subjects who underwent biopsy only without maximal safe resection.
- Subjects with a contraindication to MRI scans.
- Subjects with IDH-1 or IDH-2 mutations or H3 K27M diffuse midline glioma.
- Subjects with unresolved CNS hemorrhage, leptomeningeal or spinal metastases or ventricular invasion.
- Subjects treated with a carmustine wafer implant.
- Subjects treated with Tumor Treating Fields (TTF).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Providence Portland Cancer Institute - Franz Clinic
Portland, Oregon, 97213
Tara Foote, RN, 503-215-1979, canrsrchstudies@providence.org
Rom Leidner, MD
About this study
Official title: A First-in-human, Open-label, Dose Escalation, Phase I Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Clinical Efficacy of M3T01 Monotherapy and in Combination With Pembrolizumab and Other Systemic Therapies in Patients With Advanced Solid Tumors
Phase 1 first-in-human, open-label, dose-escalation (3 + 3), dose-expansion clinical trial to evaluate the safety, tolerability and preliminary clinical efficacy of M3T01 (fully human IgG4/kappa monoclonal antibody targeting FasL) in subjects with metastatic or unresectable solid tumors.
Read the detailed description
This is a first-in-human, phase I, open-label, dose escalation, dose expansion clinical trial designed to evaluate the safety, tolerability and preliminary clinical efficacy of M3T01 monotherapy and in combination with standard of care systemic therapies (including pembrolizumab, temozolomide, and FOLFOX) in subjects with advanced solid tumors. Within the Part 1 dose escalation stage of the study, the maximum tolerated dose (MTD) or maximum administered dose (MAD) for M3T01 monotherapy and in combination with pembrolizumab will be determined. The recommended phase 2 dose (RP2D) will be determined based upon available pharmacokinetic, pharmacodynamic, and preliminary clinical efficacy data and will be equal to or lower than the MTD. M3T01 will be administered at the RP2D in combination with standard of care systemic therapies (including pembrolizumab, temozolomide, and FOLFOX) in the Part 2 dose expansion stage of the clinical trial.
Up to 48 subjects will be enrolled in the Part 1 dose escalation stage of the study (depending on observed toxicity and when the MTD/MAD is reached). The Part 2 dose expansion portion of the study will enroll up to 62 subjects.
- Conditions
- Advanced Solid Tumors
- Being tested
- M3T01, Pembrolizumab, Chemoradiation, FOLFOX regimen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M3T01Drug
Subjects will be treated with M3T01 through an IV infusion over 1 hour given every 3 weeks.
PembrolizumabDrug
Also called KEYTRUDA
Pembrolizumab will be given as standard of care to Cohort DL 5+ under Part 1 of the study. Subjects will receive 200 mg IV once every 3 weeks.
ChemoradiationRadiation
Subjects will be treated with standard of care chemoradiation therapy consisting of TMZ 75 mg/m2 daily with concurrent radiation therapy (60 Gy administered over 6 weeks). Following chemoradiation therapy, subjects will have a 4-week break from TMZ before starting standard adjuvant TMZ 150-200 mg/m2 days 1-5 of 28-day cycles for 6 cycles. Subjects will be treated with M3T01 at the RP2D through an IV infusion every 3 weeks that will begin concurrently with chemoradiation therapy.
FOLFOX regimenDrug
Also called Oxaliplatin, Leucovorin, Fluorouracil
FOLFOX will be given as standard of care on 14 day cycles. Subjects will receive oxaliplatin 85 mg/m2 IV on Day 1, leucovorin 400 mg/m2 IV on Day 1, fluorouracil 400 mg/m2 IV push on Day 1, and fluorouracil 1,200 mg/m2 IV continuous infusion on Days 1-2 every 14 days for up to 9 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Part 1A: DL 1 | Experimental | M3T01 100 mg as monotherapy. Receives: Drug: M3T01 |
| Part 1A: DL 2 | Experimental | M3T01 200 mg as monotherapy. Receives: Drug: M3T01 |
| Part 1A: DL 3 | Experimental | M3T01 400 mg as monotherapy. Receives: Drug: M3T01 |
| Part 1A: DL 4 | Experimental | M3T01 600 mg as monotherapy. Receives: Drug: M3T01 |
| Part 1A: DL 5 | Experimental | M3T01 800 mg as monotherapy. Receives: Drug: M3T01 |
| Part 1B: DL 6 | Experimental | M3T01 400 mg in combination with pembrolizumab 200 mg. Receives: Drug: M3T01; Drug: Pembrolizumab |
| Part 1B: DL 7 | Experimental | M3T01 600 mg in combination with pembrolizumab 200 mg. Receives: Drug: M3T01; Drug: Pembrolizumab |
| Part 1B: DL 8 | Experimental | M3T01 800 mg in combination with pembrolizumab 200 mg. Receives: Drug: M3T01; Drug: Pembrolizumab |
| Part 2A: Newly diagnosed glioblastoma with unmethylated MGMT promoter | Experimental | Subjects will be treated with standard of care chemoradiation therapy consisting of TMZ 75 mg/m2 daily with concurrent radiation therapy (60 Gy administered over 6 weeks). Following chemoradiation therapy, subjects will have a 4-week break from TMZ before starting standard adjuvant TMZ 150-200 mg/m2 days 1-5 of 28-day cycles for 6 cycles. Subjects will be treated with M3T01 at the RP2D through an IV infusion every 3 weeks that will begin concurrently with chemoradiation therapy. Receives: Drug: M3T01; Radiation: Chemoradiation |
| Part 2B: First-line tx for unresectable/metastatic HER2- esophageal, GEJ, or gastric adenocarcinoma. | Experimental | Subjects with unresectable or metastatic HER2 negative esophageal, gastroesophageal (GEJ), or gastric adenocarcinoma without prior systemic therapy in the metastatic setting will be treated with M3T01 at the RPD2 in combination with standard of care pembrolizumab plus FOLFOX chemotherapy. Receives: Drug: M3T01; Drug: Pembrolizumab; Drug: FOLFOX regimen |
| Part 2C: Second-line treatment for recurrent/metastatic HNSCC | Experimental | Subjects with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who have developed disease progression after first-line systemic therapy with an anti-PD-1-based regimen in the recurrent or metastatic setting will be treated with M3T01 at the RP2D in combination with pembrolizumab 200 mg IV every 3 weeks for up to 2 years. Receives: Drug: M3T01; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent adverse events
Safety parameters including clinical assessments, vital signs, laboratory testing, and electrocardiograms (ECG) will be used to assess treatment-emergent adverse events (TEAE). Adverse events will be graded using the NCI-CTCAE v5.0. Investigators will determine relatedness of all treatment emergent adverse events (TEAE) to the investigational agent(s).
Measured: 4 years
Dose-limiting toxicities
The DLT evaluation period will be defined as the first 21 days after infusion of M3T01 as monotherapy or in combination with other systemic therapies (including pembrolizumab, temozolomide, and FOLFOX). Site investigators will grade toxicities using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: 21 days after C1D1
Serious adverse events
Clinical assessments, vital signs, laboratory testing, and electrocardiograms (ECG) will be used to assess serious adverse events (SAE) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: 4 years
Immune-related adverse events
Clinical assessments, vital signs, laboratory testing, and electrocardiograms (ECG) will be used to assess immune-related adverse events (irAE) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: 4 years
Secondary outcomes (3)
PK Profile of M3T01
Serum PK parameters including the area under the curve (AUC), maximum concentration (Cmax), minimum concentration (Cmin), time to maximum concentration (Tmax), half-life (t1/2), and other serum concentration vs time parameters.
Measured: 4 years
Immunogenicity of M3T01
- Incidence of anti-drug antibodies (ADA) and neutralizing antibodies (nAbs) against M3T01 and correlation with M3T01 PK parameters, toxicity, and clinical efficacy.
Measured: 4 years
Antitumor Activity of M3T01
Tumor response (for all solid tumors other than glioblastoma) will be evaluated by site investigators per RECIST v1.1 to assess the objective response rate (ORR), best overall response (BOR), disease control rate (DCR), duration of response (DOR), progression free survival (PFS), and overall survival (OS). Tumor assessment CT or MRI scans will be performed every 8 weeks for the first 6 months and then every 12 weeks thereafter. Tumor assessments for subjects with glioblastoma will be performed with contrast-enhanced MRI per the Response Assessment in Neuro-Oncology (RANO 2.0) criteria.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start17 Jun 2025
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Providence Health & Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rom Leidner, MD, Principal investigator, Providence Health & Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06719362
- Sponsor's protocol ID
- 2024000813
- Status last verified
- Jul 2026
- First submitted
- 21 Nov 2024
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-human, Open-label, Dose Escalation, Phase I Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Clinical Efficacy of M3T01 Monotherapy and in Combination With Pembrolizumab and Other Systemic Therapies in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06719362
- Acronym / sponsor ID
- 2024000813
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Providence Health & ServicesUniversity, hospital or other
- Study start
- 17 Jun 2025 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 5 Dec 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.
Phase 1 first-in-human, open-label, dose-escalation (3 + 3), dose-expansion clinical trial to evaluate the safety, tolerability and preliminary clinical efficacy of M3T01 (fully human IgG4/kappa monoclonal antibody targeting FasL) in subjects with metastatic or unresectable solid tumors.
Detailed description
This is a first-in-human, phase I, open-label, dose escalation, dose expansion clinical trial designed to evaluate the safety, tolerability and preliminary clinical efficacy of M3T01 monotherapy and in combination with standard of care systemic therapies (including pembrolizumab, temozolomide, and FOLFOX) in subjects with advanced solid tumors. Within the Part 1 dose escalation stage of the study, the maximum tolerated dose (MTD) or maximum administered dose (MAD) for M3T01 monotherapy and in combination with pembrolizumab will be determined. The recommended phase 2 dose (RP2D) will be determined based upon available pharmacokinetic, pharmacodynamic, and preliminary clinical efficacy data and will be equal to or lower than the MTD. M3T01 will be administered at the RP2D in combination with standard of care systemic therapies (including pembrolizumab, temozolomide, and FOLFOX) in the Part 2 dose expansion stage of the clinical trial.
Up to 48 subjects will be enrolled in the Part 1 dose escalation stage of the study (depending on observed toxicity and when the MTD/MAD is reached). The Part 2 dose expansion portion of the study will enroll up to 62 subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Part 1A: DL 1 | Experimental | Drug: M3T01M3T01 100 mg as monotherapy. |
| Part 1A: DL 2 | Experimental | Drug: M3T01M3T01 200 mg as monotherapy. |
| Part 1A: DL 3 | Experimental | Drug: M3T01M3T01 400 mg as monotherapy. |
| Part 1A: DL 4 | Experimental | Drug: M3T01M3T01 600 mg as monotherapy. |
| Part 1A: DL 5 | Experimental | Drug: M3T01M3T01 800 mg as monotherapy. |
| Part 1B: DL 6 | Experimental | Drug: M3T01, Drug: PembrolizumabM3T01 400 mg in combination with pembrolizumab 200 mg. |
| Part 1B: DL 7 | Experimental | Drug: M3T01, Drug: PembrolizumabM3T01 600 mg in combination with pembrolizumab 200 mg. |
| Part 1B: DL 8 | Experimental | Drug: M3T01, Drug: PembrolizumabM3T01 800 mg in combination with pembrolizumab 200 mg. |
| Part 2A: Newly diagnosed glioblastoma with unmethylated MGMT promoter | Experimental | Drug: M3T01, Radiation: ChemoradiationSubjects will be treated with standard of care chemoradiation therapy consisting of TMZ 75 mg/m2 daily with concurrent radiation therapy (60 Gy administered over 6 weeks). Following chemoradiation therapy, subjects will have a 4-week break from TMZ before starting standard adjuvant TMZ 150-200 mg/m2 days 1-5 of 28-day cycles for 6 cycles. Subjects will be treated with M3T01 at the RP2D through an IV infusion every 3 weeks that will begin concurrently with chemoradiation therapy. |
| Part 2B: First-line tx for unresectable/metastatic HER2- esophageal, GEJ, or gastric adenocarcinoma. | Experimental | Drug: M3T01, Drug: Pembrolizumab, Drug: FOLFOX regimenSubjects with unresectable or metastatic HER2 negative esophageal, gastroesophageal (GEJ), or gastric adenocarcinoma without prior systemic therapy in the metastatic setting will be treated with M3T01 at the RPD2 in combination with standard of care pembrolizumab plus FOLFOX chemotherapy. |
| Part 2C: Second-line treatment for recurrent/metastatic HNSCC | Experimental | Drug: M3T01, Drug: PembrolizumabSubjects with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who have developed disease progression after first-line systemic therapy with an anti-PD-1-based regimen in the recurrent or metastatic setting will be treated with M3T01 at the RP2D in combination with pembrolizumab 200 mg IV every 3 weeks for up to 2 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Age ≥ 18 years.
- Life expectancy ≥ 12 weeks.
- Provision of written informed consent (see Section 16.1 and Appendix 18.5.5) for participation in the clinical trial.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-1 for subjects with solid tumors other than glioblastoma.
- Karnofsky Performance Status of ≥ 70% for subjects with glioblastoma.
Key exclusion criteria (39 listed)
- Treatment with anticancer therapy within 14 days or 5 half-lives (whichever is shorter) of cycle 1 day 1. Palliative radiation therapy to a non-CNS metastasis is permitted if completed at least 14 days prior to cycle 1 day 1.
- History of other active malignancy that required treatment within 2 years of enrollment. Exceptions include the following:
- Clinically significant cardiovascular conditions as defined by the following:
- CNS metastases or leptomeningeal carcinomatosis (applicable to subjects with solid tumors other than glioblastoma). Subjects with brain metastases are eligible for participation if one of the following criteria are met:
- Treatment with immunosuppressive medications.
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 |
|---|---|---|
| M3T01Subjects will be treated with M3T01 through an IV infusion over 1 hour given every 3 weeks. | Drug | Part 1A: DL 1, Part 1A: DL 2, Part 1A: DL 3, Part 1A: DL 4, Part 1A: DL 5, Part 1B: DL 6, Part 1B: DL 7, Part 1B: DL 8, Part 2A: Newly diagnosed glioblastoma with unmethylated MGMT promoter, Part 2B: First-line tx for unresectable/metastatic HER2- esophageal, GEJ, or gastric adenocarcinoma., Part 2C: Second-line treatment for recurrent/metastatic HNSCC |
| PembrolizumabAlso: KEYTRUDAPembrolizumab will be given as standard of care to Cohort DL 5+ under Part 1 of the study. Subjects will receive 200 mg IV once every 3 weeks. | Drug | Part 1B: DL 6, Part 1B: DL 7, Part 1B: DL 8, Part 2B: First-line tx for unresectable/metastatic HER2- esophageal, GEJ, or gastric adenocarcinoma., Part 2C: Second-line treatment for recurrent/metastatic HNSCC |
| ChemoradiationSubjects will be treated with standard of care chemoradiation therapy consisting of TMZ 75 mg/m2 daily with concurrent radiation therapy (60 Gy administered over 6 weeks). Following chemoradiation therapy, subjects will have a 4-week break from TMZ before starting standard adjuvant TMZ 150-200 mg/m2 days 1-5 of 28-day cycles for 6 cycles. Subjects will be treated with M3T01 at the RP2D through an IV infusion every 3 weeks that will begin concurrently with chemoradiation therapy. | Radiation | Part 2A: Newly diagnosed glioblastoma with unmethylated MGMT promoter |
| FOLFOX regimenAlso: Oxaliplatin, Leucovorin, FluorouracilFOLFOX will be given as standard of care on 14 day cycles. Subjects will receive oxaliplatin 85 mg/m2 IV on Day 1, leucovorin 400 mg/m2 IV on Day 1, fluorouracil 400 mg/m2 IV push on Day 1, and fluorouracil 1,200 mg/m2 IV continuous infusion on Days 1-2 every 14 days for up to 9 cycles. | Drug | Part 2B: First-line tx for unresectable/metastatic HER2- esophageal, GEJ, or gastric adenocarcinoma. |
Primary outcome
Treatment-emergent adverse events
Time frame: 4 years
Safety parameters including clinical assessments, vital signs, laboratory testing, and electrocardiograms (ECG) will be used to assess treatment-emergent adverse events (TEAE). Adverse events will be graded using the NCI-CTCAE v5.0. Investigators will determine relatedness of all treatment emergent adverse events (TEAE) to the investigational agent(s).
Dose-limiting toxicities
Time frame: 21 days after C1D1
The DLT evaluation period will be defined as the first 21 days after infusion of M3T01 as monotherapy or in combination with other systemic therapies (including pembrolizumab, temozolomide, and FOLFOX). Site investigators will grade toxicities using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Serious adverse events
Time frame: 4 years
Clinical assessments, vital signs, laboratory testing, and electrocardiograms (ECG) will be used to assess serious adverse events (SAE) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Immune-related adverse events
Time frame: 4 years
Clinical assessments, vital signs, laboratory testing, and electrocardiograms (ECG) will be used to assess immune-related adverse events (irAE) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
3 secondary outcomes
PK Profile of M3T01
Time frame: 4 years
Immunogenicity of M3T01
Time frame: 4 years
Antitumor Activity of M3T01
Time frame: 4 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 23 Jul 2026.
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Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
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.
Rom Leidner, MD principal investigator
Providence Health & Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing M3T01, Pembrolizumab and Chemoradiation in people with Advanced Solid Tumors, run by Providence Health & Services at 1 site in United States.
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 28 inclusion and 39 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 23 Jul 2026. 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 United States. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Tara Foote, RN (503-215-1979, canrsrchstudies@providence.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-emergent adverse events (time frame: 4 years). The study lists 4 primary outcomes in all. 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 23 Jul 2026.