Advanced Solid TumorPhase 1NCT07275073
JMT106 Injection in the Treatment of Advanced Solid Tumors
A Phase 1 study testing JMT106 Injection in people with Advanced Solid Tumor and Lung Squamous Cell Carcinoma, run by Shanghai JMT-Bio Inc. at 1 site in China.
Trial summary
This study is the first-in-human Phase I study of JMT106 injection, comprising two phases: Dose escalation with backfill and cohort expansion. The planned study population consists of subjects with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Lung Squamous Cell Carcinoma, Hepatocellular Carcinoma
- What is being tested?
- JMT106 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 25 Sep 2025to 15 Nov 2028
- 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.
- Histologically or cytologically confirmed advanced solid tumor.
- Failure of at least one line of standard therapy, or no standard treatment available, or intolerant to standard treatment at the current stage.
- At least one measurable lesion according to RECIST 1.1 criteria.
- ECOG performance status of 0-1.
- Expected survival ≥3 months.
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- Sufficient organ function, with laboratory tests meeting the following criteria (no blood transfusion or hematopoietic growth factor treatment within 14 days):
- Absolute neutrophil count (ANC) ≥1.5×10⁹/L;
- Platelets (PLT) ≥90×10⁹/L;
- Hemoglobin (Hb) ≥90 g/L;
- Total bilirubin (TBIL) ≤1.5×ULN (≤3×ULN for liver metastases or hepatocellular carcinoma);
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (≤5×ULN for liver metastases or hepatocellular carcinoma);
- Creatinine clearance (Ccr) >50 mL/min (calculated by Cockcroft-Gault formula);
- Activated partial thromboplastin time (APTT) ≤1.5×ULN; INR ≤1.5×ULN.
- Fertile participants (male and female) must agree to use reliable contraception (hormonal, barrier, or abstinence) with their partners during the trial and for at least 180 days after the last dose. Female participants of childbearing potential must have a negative blood pregnancy test within 7 days before enrollment.
- Understand and voluntarily sign the informed consent form (ICF).
Who cannot join
- Previous treatment with anti-GPC3 therapy.
- Presence of spinal cord compression or clinically active central nervous system metastases (untreated or symptomatic metastases, or those requiring corticosteroids/anticonvulsants for symptom control), or carcinomatous meningitis. Patients with previously treated brain metastases (e.g., whole-brain radiotherapy or stereotactic brain radiotherapy) may be enrolled if clinically stable for ≥4 weeks with no imaging evidence of progressive brain metastases.
- Long-term immunosuppressive therapy (e.g., cyclosporine) or daily systemic steroid therapy (e.g., >20 mg prednisone or equivalent), excluding those using nasal spray, inhaled, or other topical glucocorticoid therapies.
- Adverse reactions from prior antitumor therapy not recovered to CTCAE 5.0 Grade ≤1 (excluding toxicities deemed non-risky by the investigator, e.g., alopecia).
- Any antitumor therapy (chemotherapy, targeted therapy, immunotherapy, etc.) or investigational intervention within 4 weeks or 5 half-lives (whichever is shorter) before the first dose, or traditional Chinese medicine with antitumor indications within 14 days prior.
- Grade ≥3 immune-related adverse events (irAEs, per CTCAE 5.0) from prior immunotherapy.
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- Concurrent participation in another interventional clinical trial (observational trials or follow-up phases allowed).
- Major surgery within 28 days before the first dose or planned tumor resection during the study.
- Significant bleeding tendency within 4 weeks before the first dose, or high-risk conditions (e.g., gastrointestinal hemorrhage, severe hemoptysis) per investigator judgment; hereditary bleeding disorders.
- Known severe allergy to the study drug or its excipients.
- Active bacterial, fungal, or viral infection requiring IV treatment within 14 days before randomization (prophylactic therapy allowed if no active infection symptoms); patients with viral hepatitis are allowed to receive antiviral treatment.
- Uncontrolled effusions (pleural, peritoneal, pericardial) requiring frequent drainage or intervention within 14 days before the first dose (excluding cytologic evaluation of effusions).
- History of allogeneic organ or hematopoietic stem cell transplantation.
- Immunodeficiency, including HIV-positive status.
- HBsAg-positive or HBcAb-positive with HBV-DNA >2000 IU/mL; HCV antibody-positive with HCV-RNA positivity.
- History of tuberculosis treatment within 2 years before the first dose.
- Interstitial lung disease or severe pulmonary dysfunction.
- History of inflammatory bowel disease or chronic diarrhea.
- Severe cardiovascular/cerebrovascular disease, including:
- Severe arrhythmias/conduction abnormalities (e.g., ventricular arrhythmias requiring intervention, AV block grade II-III);
- Acute coronary syndrome, congestive heart failure, stroke, or other Grade ≥3 cardiovascular events within 6 months before the first dose;
- NYHA class ≥II or LVEF <50%;
- Long QTc syndrome or QTc >480 ms (Fridericia formula), or concomitant use of QTc-prolonging drugs;
- Uncontrolled hypertension (systolic BP ≥160 mmHg and/or diastolic BP ≥100 mmHg at screening).
- Other active malignancies within 2 years (except cured localized tumors, e.g., basal cell carcinoma, squamous cell carcinoma, superficial bladder cancer, in situ prostate/cervical/breast cancer).
- Live vaccination within 28 days before the first dose (inactivated vaccines, e.g., seasonal flu vaccine, allowed).
- Pregnancy or lactation.
- Other conditions deemed unsuitable by the investigator (e.g., depression history/current treatment, psychiatric disorders affecting compliance, main portal vein tumor thrombus).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affilicated Hospital,Zhejiang University School of Medicine
Zhejiang
Liang bo, 021-22200000, hanbaohui@csco.org.cn
About this study
Official title: A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, Immunogenicity, and Preliminary Antitumor Activity of JMT106 Injection in Patients With Advanced Solid Tumors
This study is the first-in-human Phase I study of JMT106 injection, comprising two phases: Dose escalation with backfill and cohort expansion. The planned study population consists of subjects with advanced solid tumors. The objective is to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of JMT106 injection as monotherapy in participants with advanced solid tumors
- Being tested
- JMT106 Injection
- Keywords
- solid tumor
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JMT106 InjectionDrug
Use according to the protocol.
| Study group | Role | What they receive |
|---|---|---|
| JMT106 injection as single agent | Experimental | Not described Receives: Drug: JMT106 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event (AE),
Assess the incidence of all AE and serious adverse events (SAE)..
Measured: Up to 2 years
Maximum Tolerated Dose (MTD),
MTD is defined as the dose level at which the estimated value of toxicity probability is closest to the target toxicity rate (i.e., 0.3).
Measured: Up to 1 years
Dose-Limiting Toxicity (DLT)
Evaluate the incidence of DLT in different dose groups.
Measured: Up to 1 years
Dose for Expansion (RDE)
Explore the recommended dose for the cohort expansion phase.
Measured: Up to 1 years
Recommended Phase 2 Dose (RP2D)
Recommended phase II dose
Measured: Up to 1 years
Overall Response Rate (ORR)
Up to 2 years
Measured: ORR as Assessed by Investigator according to RECIST v1.1
Secondary outcomes (7)
Plasma concentrations and pharmacokinetic (PK) parameters
Tests are conducted after administration of JMT106.
Measured: About 6 months after first dosing
2. Title: ORR
ORR as Assessed by Investigator according to RECIST v1.1
Measured: Up to 2 years
Disease Control Rate (DCR)
DCR according to RECIST v1.1
Measured: Up to 2 years
Progression-Free Survival (PFS)
PFS as Determined by Investigator according to RECIST v1.1
Measured: Up to 2 years
Duration of Response (DoR)
DOR as Assessed by Investigator according to RECIST v1.1
Measured: Up to 2 years
Incidence and titers of anti-drug antibodies (ADAs) to JMT106, and incidence of neutralizing antibodies (NAbs, if applicable)
Tests are conducted after administration of JMT106.
Measured: About 6 months after first dosing
Plasma concentrations of JMT106
Tests are conducted after administration of JMT106.
Measured: About 6 months after first dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start25 Sep 2025
- Primary completion5 Nov 2026 (estimated)
- Study completion15 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 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
- NCT07275073
- Sponsor's protocol ID
- JMT106-001
- Status last verified
- Aug 2025
- First submitted
- 26 Aug 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, Immunogenicity, and Preliminary Antitumor Activity of JMT106 Injection in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07275073
- Acronym / sponsor ID
- JMT106-001
- Keywords
- solid tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai JMT-Bio Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Sep 2025 (actual)
- Primary completion
- 5 Nov 2026 (estimated)
- Study completion
- 15 Nov 2028 (estimated)
- First posted
- 10 Dec 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 the first-in-human Phase I study of JMT106 injection, comprising two phases: Dose escalation with backfill and cohort expansion. The planned study population consists of subjects with advanced solid tumors. The objective is to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of JMT106 injection as monotherapy in participants with advanced solid tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JMT106 injection as single agent | Experimental | Drug: JMT106 Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age ≥18 years.
- Histologically or cytologically confirmed advanced solid tumor.
- Failure of at least one line of standard therapy, or no standard treatment available, or intolerant to standard treatment at the current stage.
- At least one measurable lesion according to RECIST 1.1 criteria.
- ECOG performance status of 0-1.
Key exclusion criteria (28 listed)
- Previous treatment with anti-GPC3 therapy.
- Presence of spinal cord compression or clinically active central nervous system metastases (untreated or symptomatic metastases, or those requiring corticosteroids/anticonvulsants for symptom control), or carcinomatous meningitis. Patients with previously treated brain metastases (e.g., whole-brain radiotherapy or stereotactic brain radiotherapy) may be enrolled if clinically stable for ≥4 weeks with no imaging evidence of progressive brain metastases.
- Long-term immunosuppressive therapy (e.g., cyclosporine) or daily systemic steroid therapy (e.g., >20 mg prednisone or equivalent), excluding those using nasal spray, inhaled, or other topical glucocorticoid therapies.
- Adverse reactions from prior antitumor therapy not recovered to CTCAE 5.0 Grade ≤1 (excluding toxicities deemed non-risky by the investigator, e.g., alopecia).
- Any antitumor therapy (chemotherapy, targeted therapy, immunotherapy, etc.) or investigational intervention within 4 weeks or 5 half-lives (whichever is shorter) before the first dose, or traditional Chinese medicine with antitumor indications within 14 days prior.
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 |
|---|---|---|
| JMT106 InjectionUse according to the protocol. | Drug | JMT106 injection as single agent |
Primary outcome
Adverse Event (AE),
Time frame: Up to 2 years
Assess the incidence of all AE and serious adverse events (SAE)..
Maximum Tolerated Dose (MTD),
Time frame: Up to 1 years
MTD is defined as the dose level at which the estimated value of toxicity probability is closest to the target toxicity rate (i.e., 0.3).
Dose-Limiting Toxicity (DLT)
Time frame: Up to 1 years
Evaluate the incidence of DLT in different dose groups.
Dose for Expansion (RDE)
Time frame: Up to 1 years
Explore the recommended dose for the cohort expansion phase.
Recommended Phase 2 Dose (RP2D)
Time frame: Up to 1 years
Recommended phase II dose
Overall Response Rate (ORR)
Time frame: ORR as Assessed by Investigator according to RECIST v1.1
Up to 2 years
7 secondary outcomes
Plasma concentrations and pharmacokinetic (PK) parameters
Time frame: About 6 months after first dosing
2. Title: ORR
Time frame: Up to 2 years
Disease Control Rate (DCR)
Time frame: Up to 2 years
Progression-Free Survival (PFS)
Time frame: Up to 2 years
Duration of Response (DoR)
Time frame: Up to 2 years
Incidence and titers of anti-drug antibodies (ADAs) to JMT106, and incidence of neutralizing antibodies (NAbs, if applicable)
Time frame: About 6 months after first dosing
Plasma concentrations of JMT106
Time frame: About 6 months after first dosing
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 18 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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 JMT106 Injection in people with Advanced Solid Tumor and Lung Squamous Cell Carcinoma, 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 16 inclusion and 28 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 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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 Liang Ting bo, Ph.D (0571-87236666, liangtingbo@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event (AE), (time frame: Up to 2 years). The study lists 6 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 18 Dec 2025.