CancerPhase 1NCT07317505
A Phase 1 Study of JMT108 in Participants With Advanced Solid Tumors
A Phase 1 study testing JMT108 in people with Cancer and Cancer (Solid Tumors), run by Conjupro Biotherapeutics, Inc. at 3 sites in United States.
Trial summary
The goal of this clinical trial is to test JMT108, a type of drug called a bispecific antibody in adult patients with locally advanced or metastatic solid tumors. The main questions it aims to answer are: To assess the safety and tolerability of JMT108 at increasing doses and determine the dose and schedule to be used… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Cancer (Solid Tumors)
- What is being tested?
- JMT108
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 Dec 2025to Sep 2029
- 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
Major Inclusion Criteria:
- Age ≥18 years
- Participants with histologically or cytologically confirmed locally advanced or metastatic solid tumors who are unresponsive or intolerant to all standard of care or have no standard of care available
- At least one evaluable tumor lesion according to RECIST v1.1.
- ECOG performance status score ≤2.
- Expected survival ≥ 3 months
Major Exclusion Criteria:
- Active central nervous system metastases and/or leptomeningeal metastases
- AEs from prior therapy which have not recovered to Grade ≤1 or baseline as per NCI CTCAE v5.0
Prior therapy
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
NEXT Dallas
Dallas, Texas, 75039
Shiraj Sen, MD
- Recruiting
NEXT Virginia
Fairfax, Virginia, 22031
Alex Spira, MD, PhD
- Recruiting
Carolina BioOncology Institute
Huntersville, North Carolina, 28078
Neel Gandhi, MD
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
The goal of this clinical trial is to test JMT108, a type of drug called a bispecific antibody in adult patients with locally advanced or metastatic solid tumors.
The main questions it aims to answer are:
Read more
- To assess the safety and tolerability of JMT108 at increasing doses and determine the dose and schedule to be used in the second part of the study (Phase 1a)
- To assess effectiveness of JMT108 in participants with locally advanced or metastatic tumors (Phase 1b)
- To evaluate how quickly JMT108 is metabolized by the body (pharmacokinetics or PK)
- To evaluate if antibodies to the study drug develop (immunogenicity)
- To evaluate preliminary efficacy to the drug
- To explore the pharmacodynamic (PD) characteristics of JMT108
- To explore the correlation between biomarker levels and preliminary efficacy
Participants will:
- Provide written informed consent
- Undergo screening tests to ensure they are eligible for study treatment
- Attend all required study visits and receive JMT108 by intravenous injection every 2 weeks until the study doctor determines study treatment should be stopped, based on how well a participant is doing on treatment
- Be followed for progression every 3 months for up to 2 years
Read the detailed description
This Phase 1 study is a single agent, 2-part (including dose escalating and expansion) study conducted in patients with locally advanced or metastatic solid tumors who are unresponsive or intolerant to all standard of care or have no standard of care available.
Dose escalation (Phase 1a) - Dose escalation will be conducted using a BOIN design.
In the dose-escalation phase, a total of 4 dose levels-0.1 mg/kg, 0.3 mg/kg, 1 mg/kg, and 2 mg/kg-will be sequentially escalated. The BOIN design is adopted for the dose-escalation part of this study to determine the MTD. The target toxicity rate for the MTD is 0.3, and the maximum sample size for the dose-escalation BOIN design is 30 participants. Participants are enrolled to receive treatment in cohorts of size 3. Dose escalation and de-escalation decisions are made based on the occurrence of DLTs within the DLT observation window.
After thorough evaluation by the SMC, one or more dose levels may be added between the highest escalated dose level and the next lower dose level for better DLT assessment.
The dose escalation phase includes a screening period (D-28 to D-1), a treatment period, an end of treatment (EOT) visit, and a follow-up period.
Cohort expansion (Phase 1b) - Based on the results of Phase 1a, the administration dose and frequency for the cohort expansion phase of study will be determined. If necessary, several different doses/frequencies may be selected for cohort expansion. Participants may be enrolled in the cohort expansion study with tumor types including but not limited to Cohort 1: lung cancer, Cohort 2: colorectal cancer, Cohort 3: liver cancer, Cohort 4: gastric cancer, Cohort 5: melanoma and Cohort 6: other advanced solid tumors (including cervical cancer, renal cancer, bile duct cancer, head and neck squamous cell head and neck cancer, etc.).
- Conditions
- Cancer, Cancer (Solid Tumors)
- Being tested
- JMT108
- Keywords
- cancer, solid tumors, advanced malignant, colorectal cancer, hepatocellular cancer, gastric cancer, melanoma
- Medical subject headings
- Neoplasms, Colorectal Neoplasms, Liver Neoplasms, Stomach Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JMT108Drug
Administered by intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a Dose Escalation | Experimental | In the dose escalation phase, dose escalation will be conducted using a BOIN design. A total of 4 dose levels-0.1 mg/kg, 0.3 mg/kg, 1 mg/kg, and 2 mg/kg-will be sequentially escalated. Receives: Drug: JMT108 |
| Phase 1a Dose Expansion | Experimental | During the dose escalation process, dose expansion and/or exploration of different dosing frequencies (e.g., Q3W) will be conducted for the dose level that the SMC evaluates as safe/ tolerable and where anti-tumor activity is also observed. Receives: Drug: JMT108 |
| Phase 1b Cohort Expansion | Experimental | Participants may be enrolled in the cohort expansion study with tumor types including but not limited to Cohort 1: lung cancer, Cohort 2: colorectal cancer, Cohort 3: hepatic cancer, Cohort 4: gastric cancer, Cohort 5: melanoma and Cohort 6: other malignant tumors (including cervical cancer, renal cancer, bile duct cancer, squamous cell head and neck cell cancer, etc.). Based on the results of Phase 1a, the SMC will discuss and determine the administration dose and frequency for the cohort expansion study. If necessary, several different doses/frequencies may be selected for cohort expansion. Receives: Drug: JMT108 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Dose Limiting Toxicities as assessed by NCI CTCAE v5.0 (excluding cytokine release syndrome, CRS).
To evaluate the safety and tolerability of JMT108 to determine the dose and schedule to be used in phase 1b.
Measured: through study completion, an average of 1 year
Number of participants with Tumor Response as assessed by RECIST version 1.1 criteria
To evaluate preliminary efficacy of JMT108 injection as monotherapy in participants with advanced malignant tumors.
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
JMT108 Pharmacokinetics: Area under the concentration time curve over the dosing interval
JMT 108 Pharmacokinetics: Area under the concentration time curve over the dosing interval.
Measured: through study completion, an average of 1 year
JMT108 Pharmacokinetics: Elimination half-life (t1/2)
JMT108 Pharmacokinetics: Elimination half-life (t1/2)
Measured: through study completion, an average of 1 year
JMT 108 Pharmacokinetics: Clearance (CL)
JMT108 Pharmacokinetics: Clearance (CL)
Measured: through study completion, an average of 1 year
JMT108 Objective response rate (ORR)
ORR is defined as the proportion of patients in whom a complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 is observed as best overall response
Measured: through study completion, an average of 1 year
JMT108 Immunogenicity: Number of participants with anti-drug-antibody (ADA)
JMT108 Immunogenicity: Number of participants with anti-drug-antibody (ADA)
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 posted5 Jan 2026
- Study start2 Dec 2025
- Primary completionJul 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Conjupro Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07317505
- Sponsor's protocol ID
- JMT108-002
- Status last verified
- Jan 2026
- First submitted
- 25 Nov 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 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
- NCT07317505
- Acronym / sponsor ID
- JMT108-002
- Conditions
- Cancer, Cancer (Solid Tumors)
- Keywords
- cancer, solid tumors, advanced malignant, colorectal cancer, hepatocellular cancer, gastric cancer, melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Conjupro Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Dec 2025 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 5 Jan 2026 (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.
The goal of this clinical trial is to test JMT108, a type of drug called a bispecific antibody in adult patients with locally advanced or metastatic solid tumors.
The main questions it aims to answer are:
- To assess the safety and tolerability of JMT108 at increasing doses and determine the dose and schedule to be used in the second part of the study (Phase 1a)
- To assess effectiveness of JMT108 in participants with locally advanced or metastatic tumors (Phase 1b)
- To evaluate how quickly JMT108 is metabolized by the body (pharmacokinetics or PK)
- To evaluate if antibodies to the study drug develop (immunogenicity)
- To evaluate preliminary efficacy to the drug
- To explore the pharmacodynamic (PD) characteristics of JMT108
- To explore the correlation between biomarker levels and preliminary efficacy
Participants will:
- Provide written informed consent
- Undergo screening tests to ensure they are eligible for study treatment
- Attend all required study visits and receive JMT108 by intravenous injection every 2 weeks until the study doctor determines study treatment should be stopped, based on how well a participant is doing on treatment
- Be followed for progression every 3 months for up to 2 years
Detailed description
This Phase 1 study is a single agent, 2-part (including dose escalating and expansion) study conducted in patients with locally advanced or metastatic solid tumors who are unresponsive or intolerant to all standard of care or have no standard of care available.
Dose escalation (Phase 1a) - Dose escalation will be conducted using a BOIN design.
In the dose-escalation phase, a total of 4 dose levels-0.1 mg/kg, 0.3 mg/kg, 1 mg/kg, and 2 mg/kg-will be sequentially escalated. The BOIN design is adopted for the dose-escalation part of this study to determine the MTD. The target toxicity rate for the MTD is 0.3, and the maximum sample size for the dose-escalation BOIN design is 30 participants. Participants are enrolled to receive treatment in cohorts of size 3. Dose escalation and de-escalation decisions are made based on the occurrence of DLTs within the DLT observation window.
After thorough evaluation by the SMC, one or more dose levels may be added between the highest escalated dose level and the next lower dose level for better DLT assessment.
The dose escalation phase includes a screening period (D-28 to D-1), a treatment period, an end of treatment (EOT) visit, and a follow-up period.
Cohort expansion (Phase 1b) - Based on the results of Phase 1a, the administration dose and frequency for the cohort expansion phase of study will be determined. If necessary, several different doses/frequencies may be selected for cohort expansion. Participants may be enrolled in the cohort expansion study with tumor types including but not limited to Cohort 1: lung cancer, Cohort 2: colorectal cancer, Cohort 3: liver cancer, Cohort 4: gastric cancer, Cohort 5: melanoma and Cohort 6: other advanced solid tumors (including cervical cancer, renal cancer, bile duct cancer, head and neck squamous cell head and neck cancer, etc.).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1a Dose Escalation | Experimental | Drug: JMT108In the dose escalation phase, dose escalation will be conducted using a BOIN design. A total of 4 dose levels-0.1 mg/kg, 0.3 mg/kg, 1 mg/kg, and 2 mg/kg-will be sequentially escalated. |
| Phase 1a Dose Expansion | Experimental | Drug: JMT108During the dose escalation process, dose expansion and/or exploration of different dosing frequencies (e.g., Q3W) will be conducted for the dose level that the SMC evaluates as safe/ tolerable and where anti-tumor activity is also observed. |
| Phase 1b Cohort Expansion | Experimental | Drug: JMT108Participants may be enrolled in the cohort expansion study with tumor types including but not limited to Cohort 1: lung cancer, Cohort 2: colorectal cancer, Cohort 3: hepatic cancer, Cohort 4: gastric cancer, Cohort 5: melanoma and Cohort 6: other malignant tumors (including cervical cancer, renal cancer, bile duct cancer, squamous cell head and neck cell cancer, etc.). Based on the results of Phase 1a, the SMC will discuss and determine the administration dose and frequency for the cohort expansion study. If necessary, several different doses/frequencies may be selected for cohort expansion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| JMT108Administered by intravenous injection | Drug | Phase 1a Dose Escalation, Phase 1a Dose Expansion, Phase 1b Cohort Expansion |
Primary outcome
Number of participants with Dose Limiting Toxicities as assessed by NCI CTCAE v5.0 (excluding cytokine release syndrome, CRS).
Time frame: through study completion, an average of 1 year
To evaluate the safety and tolerability of JMT108 to determine the dose and schedule to be used in phase 1b.
Number of participants with Tumor Response as assessed by RECIST version 1.1 criteria
Time frame: through study completion, an average of 1 year
To evaluate preliminary efficacy of JMT108 injection as monotherapy in participants with advanced malignant tumors.
5 secondary outcomes
JMT108 Pharmacokinetics: Area under the concentration time curve over the dosing interval
Time frame: through study completion, an average of 1 year
JMT108 Pharmacokinetics: Elimination half-life (t1/2)
Time frame: through study completion, an average of 1 year
JMT 108 Pharmacokinetics: Clearance (CL)
Time frame: through study completion, an average of 1 year
JMT108 Objective response rate (ORR)
Time frame: through study completion, an average of 1 year
JMT108 Immunogenicity: Number of participants with anti-drug-antibody (ADA)
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 21 Jan 2026.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JMT108 in people with Cancer and Cancer (Solid Tumors), run by Conjupro Biotherapeutics, Inc. at 3 sites 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?
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 21 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 3 sites 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 Kevin Romanko (609-686-6502, clinicaltrials.gov@cspcus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Dose Limiting Toxicities as assessed by NCI CTCAE v5.0 (excluding cytokine release syndrome, CRS). (time frame: through study completion, an average of 1 year). 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 21 Jan 2026.