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Metastatic Colorectal Cancer (mCRC)Phase 2NCT06089330

A Study of JMT101 in Patients With Metastatic Colorectal Cancer

A Phase 2 study testing JMT101, SG001 and Irinotecan in people with Metastatic Colorectal Cancer (mCRC), run by Shanghai JMT-Bio Inc..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is a phase Ⅱ, randomized, controlled, open-label, multi-center study with safety run-in to evaluate the efficacy and safety of JMT101 combined with Irinotecan and SG001 in Patients with Metastatic Colorectal Cancer (mCRC). 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, SG001 and Irinotecan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
No sites listed yet
Study dates
Jan 2024to Dec 2024
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Age ranged from 18 to 75 years old (inclusive), regardless of gender;
  • Pathological diagnosis as metastatic colorectal adenocarcinoma, with RAS and BRAF wild-type and non-dMMR/MSI-H;
  • Tumor tissue available for central laboratory testing;
  • 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, or TAS-102;
  • Measurable disease according to RECIST1.1;
  • Eastern Cooperative Oncology Group (ECOG) score 0-1 points;
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  • Life expectancy ≥3 months
  • Adequate main organs and bone marrow function.
  • Patients must give informed consent to this study before the experiment and voluntarily sign a written informed consent form.

Who cannot join

  • Previously used anti PD-1, anti PD-L1, anti CTLA-4, or cellular immunotherapy;
  • Central nervous system metastasis or meningeal metastasis;
  • Patients with high risk of bleeding due to tumor invasion of important arteries;
  • Uncontrolled or requiring repeated drainage of pleural effusion, pericardial effusion, or abdominal effusion;
  • Patients who require continuous use of morphine-based drugs to control pain;
  • The adverse reactions of previous anti-tumor treatments (including radiotherapy) have not yet recovered to CTCAE 5.0 evaluation ≤ level 1;
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  • Diagnosed as a second primary malignant tumor within 5 years prior to the first administration of the study drug;
  • 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;
  • 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;
  • Use of immunosuppressive medications within 14 days prior to the first dose of study drug;
  • 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 UGT1A1 inhibitors within 1 week, or those who cannot suspend the use of the above drugs during the study;
  • Have received radiation therapy or other localized palliative treatment within 14 days before the first dose of study drug;
  • Have undergone major surgery (excluding needle biopsy) or suffered severe traumatic injury within 28 days before the first dose of study drug;
  • Have a history of serious cardiovascular disease;
  • Previous or current presence of interstitial pneumonia/lung disease;
  • History of autoimmune diseases;
  • A history of immunodeficiency, including HIV testing positive, or having other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation;
  • Have infectious diseases requiring systemic anti-infective treatment;
  • Active hepatitis B; hepatitis C infection; syphilis infection, active tuberculosis;
  • Known presence of hypersensitivity or intolerance to any component of EGFR monoclonal antibody, PD-1 monoclonal antibody, irinotecan hydrochloride injection, regorafenib and its excipients;
  • Women during lactation or pregnancy; women with fertility tested positive for blood pregnancy within 7 days prior to enrollment in the trial;
  • 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;
  • 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.

Clinical Trials Information Group officer contact

86-0311-69085587

ctr-contact@cspc.cn

About this study

Official title: A Randomized, Controlled, Open-label Phase Ⅱ Study of The Safety, Tolerability and Efficacy of JMT101 and Irinotecan Combined With SG001 in Patients With Metastatic Colorectal Cancer (mCRC)

This study is a phase Ⅱ, randomized, controlled, open-label, multi-center study with safety run-in to evaluate the efficacy and safety of JMT101 combined with Irinotecan and SG001 in Patients with Metastatic Colorectal Cancer (mCRC).

Being tested
JMT101, SG001, Irinotecan, Regorafenib (Stivarga)
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, IV infusion once every two weeks (one treatment cycle is 4 weeks).

  • SG001Drug

    240 mg, IV infusion once every two weeks (one treatment cycle is 4 weeks).

  • IrinotecanDrug

    180mg/m^2, IV infusion once every two weeks (one treatment cycle is 4 weeks).

  • Regorafenib (Stivarga)Drug

    160 mg, taken orally once daily for the first 21 days of each 28-day cycle.

Study groups in NCT06089330
Study groupRoleWhat they receive
JMT101+SG001+ IrinotecanExperimentalNot described
Receives: Drug: JMT101; Drug: SG001; Drug: Irinotecan
JMT101+IrinotecanExperimentalNot described
Receives: Drug: JMT101; Drug: Irinotecan
Regorafenib (Stivarga)Active comparatorNot described
Receives: Drug: Regorafenib (Stivarga)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-limiting toxicity (DLT)

    Measured: After1 cycle of treatment of the safety run-in phase patients (each cycle is 28 days)

  2. Overall response rate (ORR)

    Measured: Up to approximately 2 years

  3. Incidence and severity of adverse events (AE) and serious adverse events (SAE)

    Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.

    Measured: Up to approximately 2 years

Secondary outcomes (3)

  1. Progression-free Survival (PFS)

    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

  2. Disease Control Rate (DCR)

    Determined using RECIST v1.1 criteria.

    Measured: Up to approximately 2 years

  3. Overall Survival (OS)

    Duration from the date of initial treatment to the date of death due to any cause.

    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.

  1. First posted18 Oct 2023
  2. Study startJan 2024 (estimated)
  3. Primary completionJul 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
102 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06089330
Sponsor's protocol ID
JMT101-011
Status last verified
Oct 2023
First submitted
13 Oct 2023
Last updated
18 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JMT101, SG001 and Irinotecan 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 23 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: status not confirmed, as of the sponsor's last update on 18 Oct 2023. 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 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?

Results are not available in the source record.

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: After1 cycle of treatment of the safety run-in phase patients (each cycle is 28 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06089330.

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 Oct 2023.

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