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Colorectal CancerPhase 2NCT07474727

A Phase II Study of AMT-676 Combination Therapies in Advanced Colorectal Cancer

A Phase 2 study testing AMT-676, 5-FU and Leucovorin in people with Colorectal Cancer, run by Multitude Therapeutics Inc. at 19 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study is an open, multi-center, phase II study, aiming to evaluate the safety, tolerability and efficacy of AMT-676 combined with 5-fluorouracil, leucovorin, bevacizumab (or cetuximab) in participants with advanced colorectal cancer, and to assess the PK(Pharmacokinetic) characteristics and immunogenicity of… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Colorectal Cancer
What is being tested?
AMT-676, 5-FU and Leucovorin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
19 sitesChina
Study dates
29 Apr 2026to 28 Feb 2028
Phase
Phase 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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must be willing and able to sign the ICF, and to adhere to the study visit schedule and other protocol requirements
  • Patients with pathologically confirmed, unresectable advanced colorectal adenocarcinoma
  • Patients must have at least one measurable lesion as per RECIST version 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Life expectancy ≥6 months
  • Patients must have adequate organ function
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  • Male and female individuals with child bearing potential must agree to take effective contraceptive measures from the moment they sign the informed consent form until 6 months after the last administration of the study drug
  • WCBP(Women of Child-Bearing Potential) must have a negative serum pregnancy test within 7 days prior to first dose of the IMP
  • Male patients must agree not to donate sperm, and female patients must agree not to donate eggs, while on study treatment and for at least 3 months and 6 months, respectively, after the last dose of the IMP(Investigational Medicinal Product)
  • Availability of tumor tissue sample

Who cannot join

  • Prior treatment with any same target
  • Systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to first dose of the IMP
  • Persistent toxicities from previous systemic anti-neoplastic treatments of Grade >1
  • Major surgery within 28 days prior to first dose of the IMP, or no recovery from side effects of such intervention, or a surgery is planned to be conducted within the expected participation period of the trial or within 4 weeks after the last administration of the drug
  • History of thromboembolic or cerebrovascular events during last 6 mouths
  • During the three months prior to the first administration of the drug, there were any life-threatening bleeding events, or grade 3 or higher gastrointestinal/venous variceal bleeding events that required blood transfusion, endoscopy, or surgical treatment. Or there were other diseases that the researchers believed posed a higher risk of bleeding or thrombosis during the study period
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  • Has a history of interstitial lung disease (ILD)/pneumonitis that required steroids, or current ILD/pneumonitis, or suspected ILD/pneumonitis , or other lung disease significantly impacting lung function at baseline.
  • Any other concurrent diseases or conditions that could affect the research judgment or impede the completion of the research procedures and follow-up checks
  • Central nervous system (CNS) metastasis
  • Have a history of active or acute diverticulitis, abdominal abscess, gastrointestinal obstruction, fistula, or peritoneal cancer
  • Any evidence indicates severe or uncontrolled systemic diseases
  • Acute and/or clinically significant bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV).
  • Administration of a live vaccine within 28 days prior to the administration of the first dose of the IMP
  • Patients requiring concurrent treatment of strong/moderate inhibitors or strong inducers of cytochrome P450 3A4 or 1A2 enzyme (CYP3A or CYP1A2) within 2 weeks prior to the first dose and during the study treatment
  • Known or suspected severe allergy/hypersensitivity (resulting in treatment discontinuation) to monoclonal antibodies
  • Known or suspected intolerance to the components of the IMP
  • Concurrent participation in another investigational therapeutic clinical trial
  • Pregnant or breast-feeding females
  • Investigator determined that the trial participants who were not suitable to participate in this study for other reasons

Trial locations and contacts

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

Minqi Guan contact

15895820062

minqi.guan@multitudetherapeutics.com

19 sites in 1 country

China19 sites, 19 recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011

    Yawen Gao

    Not yet recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

    Ji Ma

    Not yet recruiting

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072

    Hao Liu

    Not yet recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

    Rongbo Lin

    Not yet recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Ruihua Xu

    Recruiting

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510280

    Jian Zhang

    Recruiting

  • The Second Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

    Xuefeng Fang

    Recruiting

  • Sir Run Run Shaw Hospital

    Hangzhou, Zhejiang, 310020

    Da Li

    Not yet recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

    Yanqiao Zhang

    Not yet recruiting

  • Shandong Cancer Hospital and Institute

    Jinan, Shandong, 250117

    Zuoxing Niu

    Qi Dang

    Recruiting

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan, 471003

    Jun Yao

    Not yet recruiting

  • Guangxi Medical University Cancer Hospital

    Nanning, Gaungxi, 530021

    Yongqiang Li

    Recruiting

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266003

    Wensheng Qiu

    Not yet recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Junjie Peng

    Recruiting

  • Shanghai Tenth People's Hospital

    Shanghai, Shanghai Municipality, 200072

    Junli Xue

    Recruiting

  • Liaoning Cancer Hospital & Institute

    Shengyang, Liaoning, 110042

    Jingdong Zhang

    Not yet recruiting

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

    Ting Deng

    Recruiting

  • Wuhan Union Hospital of China

    Wuhan, Hubei, 430022

    Tao Zhang

    Not yet recruiting

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

    Xinjun Liang

    Not yet recruiting

Other trials in China

About this study

Official title: An Phase II Study Evaluating the Safety and Efficacy of AMT-676 in Combination With 5-fluorouracil, Leucovorin, Bevacizumab (or Cetuximab) in Participants of Advanced Colorectal Cancer

This study is an open, multi-center, phase II study, aiming to evaluate the safety, tolerability and efficacy of AMT-676 combined with 5-fluorouracil, leucovorin, bevacizumab (or cetuximab) in participants with advanced colorectal cancer, and to assess the PK(Pharmacokinetic) characteristics and immunogenicity of AMT-676.

Being tested
AMT-676, 5-FU, Leucovorin, Bevacizumab, Cetuximab
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • AMT-676Drug

    Patients will get different dose levels treatment of AMT-676. AMT-676 will be Administered as an intravenous (IV) infusion every 2 weeks (Q2W) .

  • 5-FUDrug

    5-FU 400 mg/m^2 IV bolus on day 1, followed by 1200 mg/m^2/day x 2 days (total 2400 mg/m^2 over 46-48 hours) IV continuous infusion, q2w

  • LeucovorinDrug

    Leucovorin 400 mg/m^2 IV day 1, q2w

  • BevacizumabDrug

    Bevacizumab 5 mg/kg IV, day 1

  • CetuximabDrug

    Cetuximab 500 mg/m^2 IV over 2 hours, day 1, q2w

  • IrinotecanDrug

    Irinotecan 180 mg/m^2 IV, day 1

  • OxaliplatinDrug

    Oxaliplatin 85 mg/m^2 IV, day 1

Study groups in NCT07474727
Study groupRoleWhat they receive
AMT-676(dose level 1)+5-FU+Leucovorin+Bevacizumab or Cetuximab(if applicable)ExperimentalNot described
Receives: Drug: AMT-676; Drug: 5-FU; Drug: Leucovorin; Drug: Bevacizumab; Drug: Cetuximab
AMT-676(dose level 2)+5-FU+Leucovorin+Bevacizumab or Cetuximab(if applicable)ExperimentalNot described
Receives: Drug: AMT-676; Drug: 5-FU; Drug: Leucovorin; Drug: Bevacizumab; Drug: Cetuximab
oxaliplatin/irinotecan+5-FU+ leucovorin +bevacizumab (or cetuximab)ExperimentalNot described
Receives: Drug: 5-FU; Drug: Leucovorin; Drug: Bevacizumab; Drug: Cetuximab; Drug: Irinotecan; Drug: Oxaliplatin
AMT-676+5-FU+Leucovorin+Bevacizumab or Cetuximab(if applicable)+OxaliplatinExperimentalNot described
Receives: Drug: AMT-676; Drug: 5-FU; Drug: Leucovorin; Drug: Bevacizumab; Drug: Cetuximab; Drug: Oxaliplatin

What is being measured

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

  1. AE & SAE

    Type, incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

    Measured: 30 days after the last treatment

  2. MTD

    Maximum Tolerated Dose will be determined by DLTs

    Measured: 28 days after first dose

  3. DLTs

    Incidence of dose limiting toxicities

    Measured: 28 days after first dose

  4. ORR

    Overall response rate

    Measured: through study completion, an average of 18 months

  5. PFS

    Progression-free survival

    Measured: through study completion, an average of 18 months

Secondary outcomes (5)

  1. Cmax

    maximum concentration of the ADC, total antibody and free payload

    Measured: From first dose to end of treatment, an average of 1 year

  2. Ctrough

    predose concentration of the ADC, total antibody and free payload

    Measured: From first dose to end of treatment, an average of 1 year

  3. AUC

    Area Under the Curve of the ADC, total antibody and free payload

    Measured: From first dose to end of treatment, an average of 1 year

  4. Specification of anti-drug antibodies

    Measured: From first dose to end of treatment, an average of 1 year

  5. Quantification of anti-drug antibodies

    Measured: From first dose to end of treatment, 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.

  1. First posted16 Mar 2026
  2. Study start29 Apr 2026
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion28 Feb 2028 (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
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07474727
Sponsor's protocol ID
AMT-676-201
Status last verified
Aug 2026
First submitted
5 Mar 2026
Last updated
27 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AMT-676, 5-FU and Leucovorin in people with Colorectal Cancer, run by Multitude Therapeutics Inc. at 19 sites 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 10 inclusion and 19 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 27 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 19 sites 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 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 Minqi Guan (15895820062, minqi.guan@multitudetherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AE & SAE (time frame: 30 days after the last treatment). 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 NCT07474727.

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 27 Aug 2026.

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