AMT-253 in Patients With Advanced Solid Tumours

Phase I/II Study of AMT-253 in Patients With Unresectable or Metastatic Malignant Melanoma and Other Advanced Solid Tumors

This is a non-randomized, open-label, multicenter Phase I/II study of AMT-253 in patients with Unresectable or Metastatic Malignant Melanoma and other Advanced Solid Tumors. This study include phase I dose escalation and phase II dose expansion.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumors; Malignant Melanoma
• Intervention / Treatment: Drug: AMT-253 for injection

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Minqi Guan; Phone Number: 86-15895820062; Email: minqi.guan@multitudetherapeutics.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Recruiting
      • Beijing Cancer Hospital
      • Contact: Jun Guo; Phone Number: 86-010-88121122

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1. Patients must be willing and able to understand and sign the ICF, and to adhere to the study visit schedule and other protocol requirements.
• 2. Patients with histologically confirmed melanoma or other advanced solid tumor.
• 3. Patients who have undergone at least one systemic therapy and have radiologically or clinically determined progressive disease (PD) during or after most recent line of therapy, and for whom no further standard therapy is available, or who are intolerable to standard therapy.
• 4. Patients must have at least one measurable lesion as per RECIST version 1.1.
• 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• 6. Life expectancy ≥ 3 months.
• 7. Patients must have adequate organ function
• 8. Women of child bearing potential (WCBP), defined as a sexually mature woman who has not undergone surgical sterilization or who has not been naturally postmenopausal for at least 12 consecutive months must agree to use two effective contraceptive methods while on study treatment and for at least twelve weeks after the last dose of the IMP.
• 9. WCBP must have a negative serum pregnancy test within 7 days prior to first dose of the IMP.
• 10. Male patients must agree to use a latex condom, even if they had a successful vasectomy, while on study treatment and for at least twelve weeks after the last dose of the IMP.
• 11. 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 12 weeks after the last dose of the IMP.
• 12. Availability of tumor tissue sample at screening.

Exclusion Criteria:

• 1. Prior treatment with any agent that has the same target.
• 2. Central nervous system (CNS) metastasis.
• 3. Active or chronic skin disorder requiring systemic therapy.
• 4. History of Steven's Johnson's syndrome or toxic epidermal necrolysis syndrome.
• 5. Persistent toxicities from previous systemic anti-neoplastic treatments of Grade >1.
• 6. Systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to first dose of the IMP.
• 7. Major surgery within 28 days prior to first dose of the IMP, or no recovery from side effects of such intervention.
• 8. Significant cardiac disease, such as recent myocardial infarction or acute coronary syndromes, congestive heart failure， uncontrolled hypertension, uncontrolled cardiac arrhythmias.
• 9. 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.
• 10. Acute and/or clinically significant bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV).
• 11. Administration of a live vaccine within 28 days prior to the administration of the first dose of the IMP.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; AMT-253 Dose Escalation	Drug: AMT-253 for injection; Administered intravenously
Experimental: Arm 2; AMT-253 Dose Expansion	Drug: AMT-253 for injection; Administered intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DLTs	Incidence of dose limiting toxicities	21 days after first dose
AEs	Type, incidence and severity of Adverse Events	Up to 24 months
SAEs	Type, incidence and severity Serious Adverse Events (SAEs)	Up to 24 months
ORR	Overall response rate assessed by the investigator according to RECIST version 1.1	Up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	aximum concentration (Cmax)	Up to 24 months
Tmax	time to peak drug concentration	Up to 24 months
AUC	Area Under the Curve	Up to 24 months
t1/2	terminal half-life of the ADC, total antibody and free payload	Up to 24 months
ADAs	Specification and quantification of anti-drug antibodies	Up to 24 months

Collaborators and Investigators

• Sponsor: Multitude Therapeutics Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2024
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 8, 2024
• First Submitted That Met QC Criteria: January 8, 2024
• First Posted (Actual): January 17, 2024

Study Record Updates

• Last Update Posted (Estimated): September 5, 2025
• Last Update Submitted That Met QC Criteria: August 28, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Skin and Connective Tissue Diseases; Melanoma; Therapeutics; Drug Administration Routes; Drug Therapy; Injections
• Other Study ID Numbers: AMT-253-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No