Metastatic Colorectal Cancer (mCRC)Phase 3NCT07134205
The Study of JMT101 Combined With Irinotecan as a ≥3rd-Line Treatment in Metastatic Colorectal Cancer
A Phase 3 study testing JMT101, Irinotecan and Regorafenib in people with Metastatic Colorectal Cancer (mCRC), run by Shanghai JMT-Bio Inc..
Trial summary
This is a randomized, open-label, multicenter, phase III clinical study. The aim is to evaluate the efficacy of JMT101 in combination with irinotecan in the third-line and beyond treatment of Metastatic Colorectal Cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Colorectal Cancer (mCRC)
- What is being tested?
- JMT101, Irinotecan and Regorafenib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Oct 2028
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age ranged from 18 to 75 years old (inclusive), regardless of gender;
- 2. Pathological diagnosis as metastatic colorectal adenocarcinoma, with RAS and BRAF wild-type and non-dMMR/MSI-H;
- 3. Tumor tissue available for central laboratory testing;
- 4. Metastatic colorectal cancer with disease progression after 2nd line treatment; previously received standard chemotherapy based on fluorouracil, oxaliplatin, irinotecan; patients are allowed to previously receive EGFR and/or VEGF inhibitors, but not allowed to previously receive regorafenib, fruquintinib;
- 5. Measurable disease according to RECIST1.1;
- 6. Eastern Cooperative Oncology Group (ECOG) score 0-1 points;
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- 7. Life expectancy ≥3 months
- 8. Adequate main organs and bone marrow function.
- 9. Patients must give informed consent to this study before the experiment and voluntarily sign a written informed consent form.
Who cannot join
- 1. Participants who have been systematically treated with an EGFR inhibitor (such as cetuximab) within 4 months prior to the first dose of study drug.
- 2. Central nervous system metastasis or meningeal metastasis;
- 3. Patients with high risk of bleeding due to tumor invasion of important arteries;
- 4. Uncontrolled or requiring repeated drainage of pleural effusion, pericardial effusion, or abdominal effusion;
- 5. The adverse reactions of previous anti-tumor treatments (including radiotherapy) have not yet recovered to CTCAE 5.0 evaluation ≤ level 1;
- 6. Diagnosed as a second primary malignant tumor within 5 years prior to the first administration of the study drug;
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- 7. Have received anti-tumor treatments such as chemotherapy, biological therapy, targeted therapy, etc. within 21 days before the first dose of the study drug; radiotherapy within 2 weeks before the first dose of the study drug; Chinese medicine or Chinese patent medicine with anti-tumor effect within 1 week before the first dose of the study drug;
- 8. Have received a live viral vaccine or live-attenuated vaccine within 28 days before the first dose of study drug or plan to receive it during the study;
- 9. Use of immunosuppressive medications within 14 days prior to the first dose of study drug;
- 10. Those who use strong CYP3A4 inducers within 14 days before the first administration of the study drug, or those who use strong CYP3A4 inhibitors or strong UGT1A9 inhibitors within 2 week, or those who cannot suspend the use of the above drugs during the study;
- 11. Have received radiation therapy or other localized palliative treatment within 14 days before the first dose of study drug;
- 12. Have undergone major surgery (excluding needle biopsy) or suffered severe traumatic injury within 28 days before the first dose of study drug;
- 13. Have a history of serious cardiovascular disease;
- 14. Previous or current presence of interstitial pneumonia/lung disease;
- 15. History of autoimmune diseases;
- 16. A history of immunodeficiency, including HIV testing positive, or having other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation;
- 17. Have infectious diseases requiring systemic anti-infective treatment;
- 18. Active hepatitis B; hepatitis C infection; syphilis infection, active tuberculosis;
- 19. Known presence of hypersensitivity or intolerance to any component of EGFR monoclonal antibody, irinotecan hydrochloride injection, regorafenib and its excipients;
- 20. Women during lactation or pregnancy; women with fertility tested positive for blood pregnancy within 7 days prior to enrollment in the trial;
- 21. Any male and female patients with fertility who refuse to use effective contraceptive methods throughout the entire trial period and within six months after the last administration;
- 22. Other conditions that, in the opinion of the investigator, may affect the safety or compliance of drug treatment in this study, including but not limited to: psychiatric disorders, any severe or uncontrollable diseases, etc.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Open-label, Multicenter Phase III Clinical Study of JMT101 in Combination With Irinotecan in Third-line and Beyond Treatment of Metastatic Colorectal Cancer
This is a randomized, open-label, multicenter, phase III clinical study. The aim is to evaluate the efficacy of JMT101 in combination with irinotecan in the third-line and beyond treatment of Metastatic Colorectal Cancer.
Read the detailed description
This trial is conducted in patients with refractory metastatic colorectal cancer that has progressed after second-line or higher standard therapy. Eligible patients are randomized into two arms in a 1:1 ratio to receive JMT101 in combination with irinotecan or standard of care until disease progression, unacceptable toxicity or withdrawal of consent by the patient.
- Conditions
- Metastatic Colorectal Cancer (mCRC)
- Being tested
- JMT101, Irinotecan, Regorafenib
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JMT101Drug
JMT101, 6 mg/kg, administered by IV infusion once every two weeks (one treatment cycle is 4 weeks).
IrinotecanDrug
Irinotecan, 180mg/m^2, administered by IV infusion once every two weeks (one treatment cycle is 4 weeks).
RegorafenibDrug
Regorafenib, 160 mg, taken orally once daily for the first 21 days of each 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| JMT101 + Irinotecan | Experimental | JMT101, 6 mg/kg, Irinotecan, 180mg/m^2, administered by IV infusion once every two weeks (one treatment cycle is 4 weeks). Receives: Drug: JMT101; Drug: Irinotecan |
| Standard of care | Active comparator | 28 day for one cycle. Receives: Drug: Regorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
defined as the time from randomization to the first occurrence of disease progression as determined by the BIRC with use of RECIST v1.1 or death from any cause, whichever occurs first.
Measured: Up to approximately 3 years
Secondary outcomes (10)
Overall response rate (ORR)
determined by the BIRC and investigator with use of RECIST v1.1
Measured: Up to approximately 2 years
Disease Control Rate (DCR)
determined by the BIRC and investigator with use of RECIST v1.1
Measured: Up to approximately 2 years
Duration of response (DOR)
determined by the BIRC and investigator with use of RECIST v1.1
Measured: Up to approximately 2 years
Progression-free Survival (PFS)
defined as the time from randomization to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first.
Measured: Up to approximately 2 years
Overall Survival (OS)
Duration from the date of initial treatment to the date of death due to any cause.
Measured: Up to approximately 5 years
Incidence and severity of AEs
Incidence and severity of adverse events (AE). Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.
Measured: Up to approximately 2 years
Serum concentration of JMT101
Serum concentration and immunogenicity of JMT101
Measured: Up to approximately 2 years
Serum immunogenicity of JMT101
Immunogenicity of JMT101
Measured: Up to approximately 2 years
To be assessed by European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L).
use EORTC QLQ-C30 questionnaire and the EQ-5D-5L questionnaire
Measured: Up to approximately 2 years
Drug resistance
Gene Variations Detected by ctDNA and Drug Resistance Biomarkers
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal Cancer (mCRC)Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 252 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
- NCT07134205
- Sponsor's protocol ID
- JMT101-017
- Status last verified
- Jul 2025
- First submitted
- 14 Aug 2025
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multicenter Phase III Clinical Study of JMT101 in Combination With Irinotecan in Third-line and Beyond Treatment of Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07134205
- Acronym / sponsor ID
- JMT101-017
- Conditions
- Metastatic Colorectal Cancer (mCRC)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Shanghai JMT-Bio Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 21 Aug 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 is a randomized, open-label, multicenter, phase III clinical study. The aim is to evaluate the efficacy of JMT101 in combination with irinotecan in the third-line and beyond treatment of Metastatic Colorectal Cancer.
Detailed description
This trial is conducted in patients with refractory metastatic colorectal cancer that has progressed after second-line or higher standard therapy. Eligible patients are randomized into two arms in a 1:1 ratio to receive JMT101 in combination with irinotecan or standard of care until disease progression, unacceptable toxicity or withdrawal of consent by the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| JMT101 + Irinotecan | Experimental | Drug: JMT101, Drug: IrinotecanJMT101, 6 mg/kg, Irinotecan, 180mg/m^2, administered by IV infusion once every two weeks (one treatment cycle is 4 weeks). |
| Standard of care | Active comparator | Drug: Regorafenib28 day for one cycle. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1. Age ranged from 18 to 75 years old (inclusive), regardless of gender;
- 2. Pathological diagnosis as metastatic colorectal adenocarcinoma, with RAS and BRAF wild-type and non-dMMR/MSI-H;
- 3. Tumor tissue available for central laboratory testing;
- 4. Metastatic colorectal cancer with disease progression after 2nd line treatment; previously received standard chemotherapy based on fluorouracil, oxaliplatin, irinotecan; patients are allowed to previously receive EGFR and/or VEGF inhibitors, but not allowed to previously receive regorafenib, fruquintinib;
- 5. Measurable disease according to RECIST1.1;
Key exclusion criteria (22 listed)
- 1. Participants who have been systematically treated with an EGFR inhibitor (such as cetuximab) within 4 months prior to the first dose of study drug.
- 2. Central nervous system metastasis or meningeal metastasis;
- 3. Patients with high risk of bleeding due to tumor invasion of important arteries;
- 4. Uncontrolled or requiring repeated drainage of pleural effusion, pericardial effusion, or abdominal effusion;
- 5. The adverse reactions of previous anti-tumor treatments (including radiotherapy) have not yet recovered to CTCAE 5.0 evaluation ≤ level 1;
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 |
|---|---|---|
| JMT101JMT101, 6 mg/kg, administered by IV infusion once every two weeks (one treatment cycle is 4 weeks). | Drug | JMT101 + Irinotecan |
| IrinotecanIrinotecan, 180mg/m^2, administered by IV infusion once every two weeks (one treatment cycle is 4 weeks). | Drug | JMT101 + Irinotecan |
| RegorafenibRegorafenib, 160 mg, taken orally once daily for the first 21 days of each 28-day cycle. | Drug | Standard of care |
Primary outcome
Progression-free Survival (PFS)
Time frame: Up to approximately 3 years
defined as the time from randomization to the first occurrence of disease progression as determined by the BIRC with use of RECIST v1.1 or death from any cause, whichever occurs first.
10 secondary outcomes
Overall response rate (ORR)
Time frame: Up to approximately 2 years
Disease Control Rate (DCR)
Time frame: Up to approximately 2 years
Duration of response (DOR)
Time frame: Up to approximately 2 years
Progression-free Survival (PFS)
Time frame: Up to approximately 2 years
Overall Survival (OS)
Time frame: Up to approximately 5 years
Incidence and severity of AEs
Time frame: Up to approximately 2 years
Serum concentration of JMT101
Time frame: Up to approximately 2 years
Serum immunogenicity of JMT101
Time frame: Up to approximately 2 years
To be assessed by European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L).
Time frame: Up to approximately 2 years
Drug resistance
Time frame: Up to approximately 2 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 21 Aug 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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing JMT101, Irinotecan and Regorafenib in people with Metastatic Colorectal Cancer (mCRC), run by Shanghai JMT-Bio Inc..
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 22 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: opening soon, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Progression-free Survival (PFS) (time frame: Up to approximately 3 years). 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 Aug 2025; AzTrials last refreshed its copy on 26 Oct 2026.