AMT-676 in Patients With Advanced Solid Tumors

NCT06400485 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: AMT-676-01
• Study Type: interventional
• Target: 24
• Locations: 3 countries
• Sites: 13

Brief Summary

This is a first-in-human, non-randomized, open-label, multicenter Phase 1 study will evaluate the Maximum tolerated dose (MTD)/the recommended Phase 2 Dose (RP2D), safety, tolerability, anti-drug activity, pharmacokinetics, pharmacodynamics and immunogenicity of AMT-676 in Patients with Advanced Solid Tumors.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (3)

• Recommended Phase 2 Dose (RP2D)

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

  30 days after the last dose of IMP

• Maximum Tolerated Dose (MTD)

  The MTD will be determined using DLTs

  30 days after the last dose of IMP

• Type, incidence and severity of Adverse Events

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

  30 days after the last dose of IMP

Secondary Outcomes (8)

• Maximum observed concentration (C[max])

  30 days after the last dose of IMP

• Time to maximum concentration (Tmax)

  30 days after the last dose of IMP

• Area under the curve (AUC)

  30 days after the last dose of IMP

• Terminal half-life (t[1/2])

  30 days after the last dose of IMP

• Concentration of anti-drug antibodies (ADA)

  30 days after the last dose of IMP

Study Arms (1)

AMT-676 Dose escalation

EXPERIMENTAL

Drug- AMT-676 Dosage level: AMT-676 will be administered as an intravenous (IV) infusion. Dosage form: Vial Route of administration: Intravenous Infusion

Drug: AMT-676

Interventions

AMT-676 DRUG

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

AMT-676 Dose escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Multitude Therapeutics Inc.: lead

Study Sites (13)

Carolina Biooncology Institute

Huntersville, North Carolina, 28078, American Samoa

NOT YET RECRUITING

John Hopkins Sidney Kimmel Comprehensive Cancer Center

Philadelphia, Pennsylvania, 19107, American Samoa

NOT YET RECRUITING

South Texas Accelerated Research Therapeutics (start) San Antonio

San Antonio, Texas, American Samoa

NOT YET RECRUITING

SCIENTIA Clinical Research Ltd

Randwick, New South Wales, Australia

RECRUITING

Macquarie University Hospital

Macquarie, New South wWales, Australia

RECRUITING

Gallipoli Medical Research Foundation

Greenslopes, Queensland, Australia

RECRUITING

Cabrini Hospital

Melbourne, Victoria, Australia

RECRUITING

Linear Research

Nedlands, Western Australia, Australia

RECRUITING

Fujian Provincial Cancer Hospital

Fuzhou, Fujian, 350014, China

NOT YET RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

NOT YET RECRUITING

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200000, China

NOT YET RECRUITING

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610000, China

NOT YET RECRUITING

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310016, China

NOT YET RECRUITING

Central Study Contacts

Jane Zhu

CONTACT

+86 13917933915; juanjuan.zhu@multitudetherapeutics.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 6, 2024
• Study Start: June 18, 2024
• Primary Completion: October 15, 2025
• Study Completion: February 14, 2026
• Last Updated: May 2, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5); AM (3); AU (5)