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Advanced Colorectal CancerPhase 1/2NCT07737600

A Study of MRG007 Combination Therapy for Advanced Colorectal Cancer

A Phase 1/2 study testing MRG007, 5-Fluorouracil / Leucovorin Calcium and Bevacizumab in people with Advanced Colorectal Cancer, run by Lepu Biopharma Co., Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a Phase Ib/II clinical study to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of MRG007 combination therapy in patients with advanced colorectal cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Colorectal Cancer
What is being tested?
MRG007, 5-Fluorouracil / Leucovorin Calcium and Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
316 participants
Where
1 siteChina
Study dates
Aug 2026to Dec 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

  • Expected survival of ≥ 3 months.
  • Tumor tissue specimens must be provided for relevant biomarker testing. If archived tissue specimens are unavailable, a new biopsy must be performed.
  • Pathologically confirmed, unresectable locally advanced or metastatic colorectal adenocarcinoma.
  • At least one measurable lesion according to RECIST v1.1 criteria. Measurable lesions should not have received prior radiotherapy; however, measurable lesions located within a prior radiation field or after local therapy may be selected as target lesions if disease progression is confirmed.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Adequate organ function must be demonstrated.
  • Sexually active males and females of childbearing potential must agree to use highly effective contraceptive measures from the time of signing the informed consent form until 6 months after the last dose of the investigational drug. Females of childbearing potential include premenopausal females and postmenopausal females within 1 year after menopause. Females of childbearing potential must have a negative serum pregnancy test result ≤ 7 days prior to the first dose and before randomization.

Who cannot join

  • Trial participants with known deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H).
  • Trial participants with synchronous or multiple primary malignancies.
  • Residual toxicity ≥ Grade 2 resulting from prior anti-tumor therapy.
  • Symptomatic central nervous system (CNS) metastases and/or leptomeningeal metastases.
  • History of severe cardiovascular disease.
  • Cerebrovascular accident, pulmonary embolism, or deep vein thrombosis occurring within 3 months prior to the first dose of the investigational drug; thrombosis associated with implanted venous ports or catheters; or superficial vein thrombosis, except for patients with stable thrombosis after standard anticoagulation therapy. Prophylactic use of low-dose low-molecular-weight heparin is permitted.
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  • Clinically symptomatic moderate or larger volume pleural, ascitic, or pelvic effusions requiring clinical intervention, or clinically symptomatic pericardial effusion.
  • History of gastrointestinal perforation and/or fistula within 6 months prior to the first dose of the investigational drug that has not healed following surgical treatment; risk of bowel obstruction or bowel perforation; extensive bowel resection; poorly controlled Crohn's disease, ulcerative colitis, or other gastrointestinal autoimmune or inflammatory diseases; presence of pyloric obstruction and/or persistent recurrent vomiting.
  • Active chronic hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV) infection.
  • Hypersensitivity to any component or excipient of MRG007, or known ≥ Grade 3 hypersensitivity to other prior anti-CDH17 antibodies or other monoclonal antibodies.
  • Body weight loss ≥ 10% during the screening period. Any severe and/or uncontrolled systemic disease that, in the opinion of the investigator and the sponsor, renders the participant unsuitable for participation in this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Program Director contact

86-21- 67680899

ra_bj@lepubiopharma.com

China1 site

  • Peking University cancer Hospital

    Beijing, Beijing Municipality, 100142

    Lin Shen

Other trials in China

About this study

Official title: Phase Ib/II Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy of MRG007 Combination Therapy in Patients With Advanced Colorectal Cancer

This is a Phase Ib/II clinical study to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of MRG007 combination therapy in patients with advanced colorectal cancer.

Being tested
MRG007, 5-Fluorouracil / Leucovorin Calcium, Bevacizumab, Oxaliplatin, PD-1/VEGF antibody
Keywords
MRG007, Advanced Colorectal Cancer, CDH17, ADC

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRG007Drug

    MRG007 will be administrated as specified in the protocol.

  • 5-Fluorouracil / Leucovorin CalciumDrug

    5-Fluorouracil / Leucovorin Calcium will be administrated as specified in the protocol.

  • BevacizumabDrug

    Bevacizumab will be administrated as specified in the protocol.

  • OxaliplatinDrug

    Oxaliplatin will be administrated as specified in the protocol.

  • PD-1/VEGF antibodyDrug

    PD-1/VEGF antibody will be administrated as specified in the protocol.

  • CapecitabineDrug

    Capecitabine will be administrated as specified in the protocol.

Study groups in NCT07737600
Study groupRoleWhat they receive
MRG007 + 5-Fluorouracil / Leucovorin Calcium + BevacizumabExperimentalNot described
Receives: Drug: MRG007; Drug: 5-Fluorouracil / Leucovorin Calcium; Drug: Bevacizumab
MRG007 + 5-Fluorouracil / Leucovorin Calcium + Oxaliplatin + BevacizumabExperimentalNot described
Receives: Drug: MRG007; Drug: 5-Fluorouracil / Leucovorin Calcium; Drug: Bevacizumab; Drug: Oxaliplatin
MRG007 + 5-Fluorouracil / Leucovorin Calcium + Oxaliplatin + PD-1/VEGF antibodyExperimentalNot described
Receives: Drug: MRG007; Drug: 5-Fluorouracil / Leucovorin Calcium; Drug: Oxaliplatin; Drug: PD-1/VEGF antibody
MRG007 + Capecitabine + Oxaliplatin + BevacizumabExperimentalNot described
Receives: Drug: MRG007; Drug: Bevacizumab; Drug: Oxaliplatin; Drug: Capecitabine

What is being measured

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

  1. Dose Limiting Toxicity (DLT)

    Measured: From the first dose to 30 days after the last dose

  2. Serious Adverse Events (SAEs)

    Measured: From the first dose to 30 days after the last dose

  3. Adverse Event (AE)

    Measured: From the first dose to 30 days after the last dose

  4. Recommended Phase 2 Dose(RP2D) and/or Maximum Tolerated Dose (MTD)

    Measured: From the first dose to 30 days after the last dose

  5. Objective Response Rate (ORR)

    Measured: Assessments will be performed every 6 weeks (± 7 days) following the first dose.

Secondary outcomes (7)

  1. Serum Concentration

    Serum Concentration of ADC, TAb, free payload will be measured.

    Measured: up to 2 years

  2. Anti-Drug Antibody (ADA)

    The proportion of patients with positive ADA results.

    Measured: up to 2 years

  3. Neutralizing antibody (NAb)

    The proportion of patients with positive NAb results.

    Measured: up to 2 years

  4. Duration of Response (DOR)

    Measured: Through study completion, an average 2 years

  5. Disease Control Rate (DCR)

    Measured: Through study completion, an average 2 years

  6. Progression-Free Survival (PFS)

    Measured: Through study completion, an average 2 years

  7. Overall Survival (OS)

    Measured: Through study completion, an average 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 posted30 Jul 2026
  2. Study startAug 2026 (estimated)
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2029 (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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
316 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07737600
Sponsor's protocol ID
MRG007-102
Status last verified
Jul 2026
First submitted
27 Jul 2026
Last updated
4 Aug 2026
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 1/2 study testing MRG007, 5-Fluorouracil / Leucovorin Calcium and Bevacizumab in people with Advanced Colorectal Cancer, run by Lepu Biopharma Co., Ltd. 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 7 inclusion and 11 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 4 Aug 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 Program Director (86-21- 67680899, ra_bj@lepubiopharma.com), 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: From the first dose to 30 days after the last dose). The study lists 5 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 NCT07737600.

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 4 Aug 2026.

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