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Advanced Solid TumorsEarly Phase 1NCT06400485

AMT-676 in Patients With Advanced Solid Tumors

A Early Phase 1 study testing AMT-676 in people with Advanced Solid Tumors, run by Multitude Therapeutics Inc. at 13 sites in 3 countries.

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 is a first-in-human, open-label, multicenter Phase Ia/Ib study of AMT- 676, followed by an open-label, multicenter, dose-escalation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
AMT-676
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
13 sitesin 3 countries
Study dates
18 Jun 2024to 31 Dec 2027
Phase
Early Phase 1
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

  • Patients must be willing and able to sign the ICF, and to adhere to the study visit Schedule and other protocol requirements.
  • Age ≥18 years (at the time consent is obtained).
  • Patients with pathologically confirmed unresectable advanced solid tumor. Preferred tumor types include colorectal cancer, gastric cancer, esophageal adenocarcinoma, cholangiocarcinoma, pancreatic ductal cancers, and neuroendocrine tumors.
  • Patients who have undergone at least one systemic therapy and have radiologically or clinically determined progressive disease during or after most recent line of therapy, and for whom no further standard therapy is available, or who are intolerable to standard therapy.
  • Patients must have at least one measurable lesion as per RECIST version 1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
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  • Life expectancy ≥3 months.
  • Patients must have adequate organ function
  • Women of child-bearing potential (WCBP) must have a negative serum pregnancy test.
  • Male patients must agree to use a latex condom, even if they had a successful vasectomy, while on study treatment and for at least 6months after the last 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.
  • Availability of tumour tissue sample (either an archival specimen or a fresh biopsy material) at screening.

Who cannot join

  • Prior treatment with any agent for the same target or ADC based on topoisomerase I inhibitor.
  • Central nervous system (CNS) metastasis
  • History of Steven's Johnson's syndrome or toxic epidermal necrolysis syndrome.
  • Persistent toxicities from previous systemic anti-neoplastic treatments of Grade >1.
  • Systemic anti-neoplastic therapy within five half-lives or21 days, whichever is shorter, prior to first dose of the IMP.
  • Radiotherapy to lung field at a total radiation dose of ≥20 Gy within 6 months, wide-field radiotherapy (e.g., >30% of marrow-bearing bones) within 28 days.
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  • Major surgery (not including placement of vascular access device or tumor biopsies) within 28 days prior to first dose of the IMP, or no recovery from side effects of such intervention.
  • Significant cardiac disease, such as recent (within months prior to first dose of the IMP) myocardial infarction or acute coronary syndromes (including unstable angina pectoris), congestive heart failure (New York Heart Association class III or IV), uncontrolled hypertension (SBP ≥ 160mmHg or DBP ≥ 100mmHg), uncontrolled cardiac arrhythmias.
  • Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, or current ILD/pneumonitis, or suspected ILD/pneumonitis (e.g., idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, etc.) or other lung disease significantly impacting lung function at baseline.
  • History of thromboembolic or cerebrovascular events, including transient ischemic attacks, cerebrovascular accidents, deep vein thrombosis, or pulmonary emboli within six months prior to first dose of the IMP.
  • 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 inhibitors or 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.
  • Patients with known active alcohol or drug abuse.
  • Pregnant or breast-feeding females
  • Mental or medical conditions that prevent the patient from giving informed consent or complying with the trial or other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with the study participation or the IMP administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for enrolment in this study.
  • Prior history of malignancy other than inclusion diagnosis within five years prior to first dose of the IMP.

Trial locations and contacts

13 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Jane Zhu contact

+86 13917933915

juanjuan.zhu@multitudetherapeutics.com

13 sites in 3 countries

Australia5 sites, 5 recruiting

  • Gallipoli Medical Research Foundation

    Greenslopes, Queensland

    Recruiting

  • Macquarie University Hospital

    Macquarie, New South wWales

    Recruiting

  • Cabrini Hospital

    Melbourne, Victoria

    Recruiting

  • Linear Research

    Nedlands, Western Australia

    Recruiting

  • SCIENTIA Clinical Research Ltd

    Randwick, New South Wales

    Charlotte Lemech, charlotte.lemech@scientiaclinicalresearch.com

    Recruiting

Other trials in Australia

China5 sites, 5 recruiting

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610000

    Hao Liu

    Not yet recruiting

  • Fujian Provincial Cancer Hospital

    Fuzhou, Fujian, 350014

    Robo Lin

    Not yet recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Ruihua Xu

    Not yet recruiting

  • Sir Run Run Shaw Hospital

    Hangzhou, Zhejiang, 310016

    Hongming Pan

    Not yet recruiting

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200000

    Junli Xue

    Not yet recruiting

Other trials in China

American Samoa3 sites, 3 recruiting

  • Carolina Biooncology Institute

    Huntersville, North Carolina, 28078

    Neel Gandhi, 9804411035, ngandhi@carolinabiooncology.org

    Not yet recruiting

  • John Hopkins Sidney Kimmel Comprehensive Cancer Center

    Philadelphia, Pennsylvania, 19107

    Daniel Lin, 2159556923, Daniel.Lin@jefferson.edu

    Not yet recruiting

  • South Texas Accelerated Research Therapeutics (start) San Antonio

    San Antonio, Texas

    Drew Rasco, 2105935232, drew.rasco@startsa.com

    Not yet recruiting

About this study

Official title: First-in-Human, Phase I/II Study of AMT-676, an Anti CDH17 Antibody-Drug Conjugate, in Patients With Advanced Solid Tumors

This is a first-in-human, open-label, multicenter Phase Ia/Ib study of AMT- 676, followed by an open-label, multicenter, dose-escalation.

Being tested
AMT-676

What participants receive

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

  • AMT-676Drug

    Participants will receive AMT-676 administered intravenously. Participants will be observed for first instance of dose limiting toxicities (DLT).

Study groups in NCT06400485
Study groupRoleWhat they receive
AMT-676 Dose escalationExperimentalDrug- AMT-676 Dosage level: AMT-676 will be administered as an intravenous (IV) infusion. Dosage form: Vial Route of administration: Intravenous Infusion
Receives: Drug: AMT-676

What is being measured

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

  1. Recommended Phase 2 Dose (RP2D)

    The RP2D will be determined using dose limiting toxicities (DLTs) and all other available study data

    Measured: 30 days after the last dose of IMP

  2. Maximum Tolerated Dose (MTD)

    The MTD will be determined using DLTs

    Measured: 30 days after the last dose of IMP

  3. Type, incidence and severity of Adverse Events

    Safety and tolerability profile assessed by the Common Terminology Criteria for Adverse Events v5.0

    Measured: 30 days after the last dose of IMP

Secondary outcomes (8)

  1. Maximum observed concentration (C[max])

    Pharmacokinetic profile characterized by the maximum observed concentration (C[max]) of AMT-676

    Measured: 30 days after the last dose of IMP

  2. Time to maximum concentration (Tmax)

    Pharmacokinetic profile characterized by the time to maximum concentration (Tmax) of AMT-676

    Measured: 30 days after the last dose of IMP

  3. Area under the curve (AUC)

    Pharmacokinetic profile characterized by the area under the curve (AUC) of AMT-676

    Measured: 30 days after the last dose of IMP

  4. Terminal half-life (t[1/2])

    Pharmacokinetic profile characterized by the terminal half-life (t[1/2]) of AMT-676

    Measured: 30 days after the last dose of IMP

  5. Concentration of anti-drug antibodies (ADA)

    Immunogenicity profile characterized by concentration of ADAs

    Measured: 30 days after the last dose of IMP

  6. Overall Response Rate (ORR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Proportion of patients achieving Complete Response (CR) or Partial Response (PR)

    Measured: 30 days after the last dose of IMP

  7. Disease Control Rate (DCR) according to the RECIST v1.1

    Proportion of patients achieving CR, PR or Stable Disease (SD)

    Measured: 30 days after the last dose of IMP

  8. Progression-free Survival (PFS)

    Time from date of start of treatment to date of the first progression or death, whichever occurs first

    Measured: 30 days after the last dose of IMP

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2024
  2. Study start18 Jun 2024
  3. Primary completion15 May 2027 (estimated)
  4. Study completion31 Dec 2027 (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
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06400485
Sponsor's protocol ID
AMT-676-01
Status last verified
May 2026
First submitted
1 May 2024
Last updated
18 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wang YN, Ruan DY, Shi J, Huang Y, Sheng H, Huang YL, Ma L, Wang L, Chen C, Wang Y, Zhang Y, Shen Y, Zhang Q, Zhang J, Tang Y, Zhang JL, Hu JJ, Wu CY, Chen JY, Meng X, Liu SH, Wang F. Discovery and Optimization of AMT-676, a CDH17-Targeting ADC for the Treatment of Advanced Gastrointestinal Cancers. Adv Sci (Weinh). 2026 Sep 9:e77521. doi: 10.1002/advs.77521. Online ahead of print.

    PubMed 42713665

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing AMT-676 in people with Advanced Solid Tumors, run by Multitude Therapeutics Inc. at 13 sites in 3 countries.

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 12 inclusion and 20 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 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Australia, China, American Samoa. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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 Jane Zhu (+86 13917933915, juanjuan.zhu@multitudetherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recommended Phase 2 Dose (RP2D) (time frame: 30 days after the last dose of IMP). 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 NCT06400485, which also lists 1 linked publication.

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 May 2026.

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