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

August 24, 2026 updated by: Multitude Therapeutics Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Not yet recruiting
        • Fujian Cancer Hospital
        • Contact:
          • Rongbo Lin
    • Gaungxi
      • Nanning, Gaungxi, China, 530021
        • Recruiting
        • Guangxi Medical University Cancer Hospital
        • Contact:
          • Yongqiang Li
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
          • Ruihua Xu
      • Guangzhou, Guangdong, China, 510280
        • Recruiting
        • ZhuJiang Hospital of Southern Medical University
        • Contact:
          • jian Zhang
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Not yet recruiting
        • Harbin Medical University Cancer Hospital
        • Contact:
          • Yanqiao Zhang
    • Henan
      • Luoyang, Henan, China, 471003
        • Not yet recruiting
        • The First Affiliated Hospital of Henan University of Science and Technology
        • Contact:
          • Jun Yao
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Not yet recruiting
        • Hubei Cancer Hospital
        • Contact:
          • Xinjun Liang
      • Wuhan, Hubei, China, 430022
        • Not yet recruiting
        • Wuhan Union Hospital of China
        • Contact:
          • Tao Zhang
    • Hunan
      • Changsha, Hunan, China, 410011
        • Not yet recruiting
        • The Second Xiangya Hospital of Central South University
        • Contact:
          • Yawen Gao
    • Liaoning
      • Shengyang, Liaoning, China, 110042
        • Not yet recruiting
        • Liaoning Cancer Hospital & Institute
        • Contact:
          • Jingdong Zhang
    • Shandong
      • Jinan, Shandong, China, 250117
        • Recruiting
        • Shandong Cancer Hospital And Institute
        • Contact:
          • Zuoxing Niu
        • Principal Investigator:
          • Qi Dang
      • Qingdao, Shandong, China, 266003
        • Not yet recruiting
        • The Affiliated Hospital of Qingdao University
        • Contact:
          • Wensheng Qiu
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
          • Junjie Peng
      • Shanghai, Shanghai Municipality, China, 200072
        • Recruiting
        • Shanghai Tenth People's Hospital
        • Contact:
          • Junli Xue
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Not yet recruiting
        • West China Hospital of Sichuan University
        • Contact:
          • Ji Ma
      • Chengdu, Sichuan, China, 610072
        • Not yet recruiting
        • Sichuan Provincial People's Hospital
        • Contact:
          • Hao Liu
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Recruiting
        • Tianjin Medical University Cancer Institute and Hospital
        • Contact:
          • Ting Deng
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • The Second Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:
          • Xuefeng Fang
      • Hangzhou, Zhejiang, China, 310020
        • Not yet recruiting
        • Sir Run Run Shaw Hospital
        • Contact:
          • Da Li

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AMT-676(dose level 1)+5-FU+Leucovorin+Bevacizumab or Cetuximab(if applicable)
Drug: 5-FU
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
Drug: Leucovorin
Leucovorin 400 mg/m^2 IV day 1, q2w
Drug: Bevacizumab
Bevacizumab 5 mg/kg IV, day 1
Drug: Cetuximab
Cetuximab 500 mg/m^2 IV over 2 hours, day 1, q2w
Drug: AMT-676
Patients will get different dose levels treatment of AMT-676. AMT-676 will be Administered as an intravenous (IV) infusion every 2 weeks (Q2W) .
Experimental: AMT-676(dose level 2)+5-FU+Leucovorin+Bevacizumab or Cetuximab(if applicable)
Drug: 5-FU
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
Drug: Leucovorin
Leucovorin 400 mg/m^2 IV day 1, q2w
Drug: Bevacizumab
Bevacizumab 5 mg/kg IV, day 1
Drug: Cetuximab
Cetuximab 500 mg/m^2 IV over 2 hours, day 1, q2w
Drug: AMT-676
Patients will get different dose levels treatment of AMT-676. AMT-676 will be Administered as an intravenous (IV) infusion every 2 weeks (Q2W) .
Experimental: oxaliplatin/irinotecan+5-FU+ leucovorin +bevacizumab (or cetuximab)
Drug: 5-FU
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
Drug: Leucovorin
Leucovorin 400 mg/m^2 IV day 1, q2w
Drug: Bevacizumab
Bevacizumab 5 mg/kg IV, day 1
Drug: Cetuximab
Cetuximab 500 mg/m^2 IV over 2 hours, day 1, q2w
Drug: Irinotecan
Irinotecan 180 mg/m^2 IV, day 1
Drug: Oxaliplatin
Oxaliplatin 85 mg/m^2 IV, day 1
Experimental: AMT-676+5-FU+Leucovorin+Bevacizumab or Cetuximab(if applicable)+Oxaliplatin
Drug: 5-FU
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
Drug: Leucovorin
Leucovorin 400 mg/m^2 IV day 1, q2w
Drug: Bevacizumab
Bevacizumab 5 mg/kg IV, day 1
Drug: Cetuximab
Cetuximab 500 mg/m^2 IV over 2 hours, day 1, q2w
Drug: Oxaliplatin
Oxaliplatin 85 mg/m^2 IV, day 1
Drug: AMT-676
Patients will get different dose levels treatment of AMT-676. AMT-676 will be Administered as an intravenous (IV) infusion every 2 weeks (Q2W) .

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
AE & SAE
Time Frame: 30 days after the last treatment
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
30 days after the last treatment
MTD
Time Frame: 28 days after first dose
Maximum Tolerated Dose will be determined by DLTs
28 days after first dose
DLTs
Time Frame: 28 days after first dose
Incidence of dose limiting toxicities
28 days after first dose
ORR
Time Frame: through study completion, an average of 18 months
Overall response rate
through study completion, an average of 18 months
PFS
Time Frame: through study completion, an average of 18 months
Progression-free survival
through study completion, an average of 18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: From first dose to end of treatment, an average of 1 year
maximum concentration of the ADC, total antibody and free payload
From first dose to end of treatment, an average of 1 year
Ctrough
Time Frame: From first dose to end of treatment, an average of 1 year
predose concentration of the ADC, total antibody and free payload
From first dose to end of treatment, an average of 1 year
AUC
Time Frame: From first dose to end of treatment, an average of 1 year
Area Under the Curve of the ADC, total antibody and free payload
From first dose to end of treatment, an average of 1 year
Specification of anti-drug antibodies
Time Frame: From first dose to end of treatment, an average of 1 year
From first dose to end of treatment, an average of 1 year
Quantification of anti-drug antibodies
Time Frame: From first dose to end of treatment, an average of 1 year
From first dose to end of treatment, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Multitude Therapeutics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 29, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AMT-676-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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