Advanced Malignant TumorsPhase 1/2NCT06877650
First-in-Human Investigation of JMT108 Injection in Participants With Advanced Malignant Tumors
A Phase 1/2 study testing JMT108, Pembrolizumab and Ivonescimab in people with Advanced Malignant Tumors, run by Shanghai JMT-Bio Inc. at 1 site in China.
Trial summary
This study is designed as an open-label, multi-center Phase 1 clinical study in participants with advanced malignant tumors to evaluate the safety, tolerability, PK characteristics, and preliminary anti-tumor activity of JMT108 injection, and to determine the RP2D/schedule for subsequent studies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Tumors
- What is being tested?
- JMT108, Pembrolizumab and Ivonescimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 436 participants
- Where
- 1 siteChina
- Study dates
- 11 Apr 2025to 30 Mar 2029
- Phase
- Phase 1/2
- 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
- Fully informed of the study, with good compliance and willing to provide written informed consent.
- Male or female participants aged ≥18 years (at the time of obtaining informed consent).
- Participants with histologically or cytologically confirmed advanced malignant tumors who are unresponsive or intolerant to all standard of care, or have no standard of care available. For locally advanced (stage IIIB/IIIC) or metastatic (stage IV) NSCLC without sensitive gene mutations, participants who have not received systemic treatment in the advanced stage and are unwilling to accept the current standard treatment can also be enrolled in the cohort expansion phase.
- Participants with at least one evaluable tumor lesion in the Phase 1a dose-escalation phase; and at least one measurable lesion in the Phase 1a dose-expansion phase and Phase 1b (tumor lesions in the past radiation fields or that underwent locoregional therapy are generally not considered measurable lesions unless the lesion shows definite progression or persists three months after radiotherapy) according to RECIST v1.1.
- Stage I: ECOG performance score ≤ 2. Stage II: ECOG performance score 0-1
- Expected survival ≥ 3 months.
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- Adequate organ function status:
- Hematology: PLT ≥ 100×109/L; Hb ≥ 90 g/L; ANC) ≥ 1.5×109/L (No blood transfusion, platelet transfusion, or hematopoietic stimulating factor therapy within 14 days prior to hematology test during the screening period); Liver function: AST and ALT ≤3×ULN (≤5×ULN if there is liver involvement by the tumor); TBIL ≤1.5×ULN; Renal function: Ccr > 50 ml/min (calculated by the Cockcroft-Gault formula); Coagulation function: APTT ≤ 1.5×ULN; INR ≤ 1.5×ULN; For participants on full - dose oral anticoagulant therapy, maintain a stable dosage for at least 14 days. If on warfarin, INR ≤ 3.0 with no active hemorrhage (e.g., no bleeding 14 days before the first dose of the investigational drug). Low molecular weight heparin use is permitted.
- Albumin: ≥30 g/L (≥3.0 g/dL).
Who cannot join
- Any other unapproved investigational drugs or treatments within 4 weeks prior to the first dose of the investigational drug (C1D1).
- Chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy, or other anti-tumor therapies within 4 weeks prior to the first dose of the investigational drug, except in the following situations:
- Nitrosoureas or mitomycin C within 6 weeks prior to the first dose of the investigational drug; Use of oral fluoropyrimidines and small-molecule targeted drugs within 2 weeks or 5 half-lives of the drug (whichever is longer) prior to the first dose of the investigational drug; Use of herbal medicine/products with anti-tumor indications within 2 weeks prior to the first dose of the investigational drug.
- Major surgery (excluding biopsy) or experienced severe trauma within 4 weeks prior to the first dose of the investigational drug, or plan to do major surgery during the study period.
- Systemic corticosteroids or other immunosuppression therapy within 14 days prior to the first dose of the investigational drug. Except for the following situations: use of physiological replacement doses of hydrocortisone or other equivalent doses of hormones (i.e., prednisone ≤10 mg/day or other equivalent doses of hormones); use of topical, ocular, intra-articular, intranasal, and inhaled corticosteroid therapy; use of short-course glucocorticoids for prophylaxis (e.g., prevention of contrast allergy).
- Live vaccines within 4 weeks prior to the first dose of investigational drug. Note: Seasonal influenza vaccines are inactivated vaccines in a broad sense and are allowed. Intranasal influenza vaccines are live vaccines and are not permitted.
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- History of hematopoietic stem cell transplant or organ transplant.
- AEs from prior therapy which have not recovered to Grade ≤1 or baseline as per NCI CTCAE v5.0 (excluding toxicities evaluated by the investigator to have no safety risk, such as alopecia, Grade 2 peripheral neurotoxicity, hypothyroidism stabilized with hormone replacement therapy, etc.).
- Active central nervous system metastases and/or leptomeningeal metastases. Participants with brain metastases who have confirmed progression-free status by imaging examinations for at least 4 weeks after treatment and who have not required hormonal or antiepileptic therapy for at least 2 weeks may be considered for enrollment.
- History of interstitial lung disease or pneumonitis.
- History of serious cardiovascular and cerebrovascular diseases.
- Active or recurrent autoimmune diseases (such as systemic lupus erythematosus, arthritis, vasculitis, etc.).
- History of Grade ≥3 immune-related AE or Grade ≥2 immune-related myocarditis considered related to prior immune modulatory therapytherapy.
- Hemorrhage of Grade ≥2 as per NCI CTCAE v5.0 within 4 weeks prior to the first dose of the investigational drug.
- -
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
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality
Clinical Trials Information Group officer, 86-0311-69085587, ctr-contact@cspc.cn
About this study
Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of JMT108 Injection in Participants With Advanced Malignant Tumors.
This study is designed as an open-label, multi-center Phase 1 clinical study in participants with advanced malignant tumors to evaluate the safety, tolerability, PK characteristics, and preliminary anti-tumor activity of JMT108 injection, and to determine the RP2D/schedule for subsequent studies.
- Conditions
- Advanced Malignant Tumors
- Being tested
- JMT108, Pembrolizumab, Ivonescimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JMT108Drug
Intravenous (IV) administration every three weeks (D1) in a 3-week cycle.
PembrolizumabDrug
Intravenous (IV) administration every three weeks (D1) in a 3-week cycle.
IvonescimabDrug
Intravenous (IV) administration every three weeks (D1) in a 3-week cycle.
| Study group | Role | What they receive |
|---|---|---|
| JMT108 | Experimental | Not described Receives: Drug: JMT108; Drug: Pembrolizumab; Drug: Ivonescimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicity(DLT)
To evaluate the safery of JMT108 in subjects.
Measured: Approximately 28 days.
Adverse Events (AEs)
To evaluate the safery of JMT108 in subjects
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Maximum plasma concentration (Cmax)
To evaluate the systemic pharmacokinetics of JMT108 in subjects.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start11 Apr 2025
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant TumorsStudies of the same condition, open and under way.
- More trials run by Shanghai JMT-Bio Inc.The sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is designed as an open-label, multi-center Phase 1 clinical study in participants with advanced malignant tumors to evaluate the safety, tolerability, PK characteristics, and preliminary anti-tumor activity of JMT108 injection, and to determine the RP2D/schedule for subsequent studies.
- Masking
- None (open label)
- Enrolment
- 436 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai JMT-Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06877650
- Sponsor's protocol ID
- JMT108-001
- Status last verified
- Apr 2025
- First submitted
- 6 Mar 2025
- Last updated
- 29 Jan 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 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of JMT108 Injection in Participants With Advanced Malignant Tumors.
- ClinicalTrials.gov ID
- NCT06877650
- Acronym / sponsor ID
- JMT108-001
- Conditions
- Advanced Malignant Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 436 participants (estimated)
- Lead sponsor
- Shanghai JMT-Bio Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Apr 2025 (actual)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 14 Mar 2025 (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 study is designed as an open-label, multi-center Phase 1 clinical study in participants with advanced malignant tumors to evaluate the safety, tolerability, PK characteristics, and preliminary anti-tumor activity of JMT108 injection, and to determine the RP2D/schedule for subsequent studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is designed as an open-label, multi-center Phase 1 clinical study in participants with advanced malignant tumors to evaluate the safety, tolerability, PK characteristics, and preliminary anti-tumor activity of JMT108 injection, and to determine the RP2D/schedule for subsequent studies.
| Arm | Type | Receives |
|---|---|---|
| JMT108 | Experimental | Drug: JMT108, Drug: Pembrolizumab, Drug: Ivonescimab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Fully informed of the study, with good compliance and willing to provide written informed consent.
- Male or female participants aged ≥18 years (at the time of obtaining informed consent).
- Participants with histologically or cytologically confirmed advanced malignant tumors who are unresponsive or intolerant to all standard of care, or have no standard of care available. For locally advanced (stage IIIB/IIIC) or metastatic (stage IV) NSCLC without sensitive gene mutations, participants who have not received systemic treatment in the advanced stage and are unwilling to accept the current standard treatment can also be enrolled in the cohort expansion phase.
- Participants with at least one evaluable tumor lesion in the Phase 1a dose-escalation phase; and at least one measurable lesion in the Phase 1a dose-expansion phase and Phase 1b (tumor lesions in the past radiation fields or that underwent locoregional therapy are generally not considered measurable lesions unless the lesion shows definite progression or persists three months after radiotherapy) according to RECIST v1.1.
- Stage I: ECOG performance score ≤ 2. Stage II: ECOG performance score 0-1
Key exclusion criteria (15 listed)
- Any other unapproved investigational drugs or treatments within 4 weeks prior to the first dose of the investigational drug (C1D1).
- Chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy, or other anti-tumor therapies within 4 weeks prior to the first dose of the investigational drug, except in the following situations:
- Nitrosoureas or mitomycin C within 6 weeks prior to the first dose of the investigational drug; Use of oral fluoropyrimidines and small-molecule targeted drugs within 2 weeks or 5 half-lives of the drug (whichever is longer) prior to the first dose of the investigational drug; Use of herbal medicine/products with anti-tumor indications within 2 weeks prior to the first dose of the investigational drug.
- Major surgery (excluding biopsy) or experienced severe trauma within 4 weeks prior to the first dose of the investigational drug, or plan to do major surgery during the study period.
- Systemic corticosteroids or other immunosuppression therapy within 14 days prior to the first dose of the investigational drug. Except for the following situations: use of physiological replacement doses of hydrocortisone or other equivalent doses of hormones (i.e., prednisone ≤10 mg/day or other equivalent doses of hormones); use of topical, ocular, intra-articular, intranasal, and inhaled corticosteroid therapy; use of short-course glucocorticoids for prophylaxis (e.g., prevention of contrast allergy).
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 |
|---|---|---|
| JMT108Intravenous (IV) administration every three weeks (D1) in a 3-week cycle. | Drug | JMT108 |
| PembrolizumabIntravenous (IV) administration every three weeks (D1) in a 3-week cycle. | Drug | JMT108 |
| IvonescimabIntravenous (IV) administration every three weeks (D1) in a 3-week cycle. | Drug | JMT108 |
Primary outcome
Dose-Limiting Toxicity(DLT)
Time frame: Approximately 28 days.
To evaluate the safery of JMT108 in subjects.
Adverse Events (AEs)
Time frame: through study completion, an average of 1 year
To evaluate the safery of JMT108 in subjects
1 secondary outcome
Maximum plasma concentration (Cmax)
Time frame: through study completion, an average of 1 year
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 29 Jan 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing JMT108, Pembrolizumab and Ivonescimab in people with Advanced Malignant Tumors, run by Shanghai JMT-Bio Inc. 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 9 inclusion and 15 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 29 Jan 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 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-Limiting Toxicity(DLT) (time frame: Approximately 28 days.). The study lists 2 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 29 Jan 2026.