AMT-253 in Patients With Advanced Solid Tumours

Phase 1

Recruiting

• Conditions: Malignant Melanoma; Advanced Solid Tumors
• Interventions: Drug: AMT-253 for injection

• Registration Number: NCT06209580
• Lead Sponsor: Multitude Therapeutics Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2024-01-08
• Study First Submitted QC: 2024-01-08
• Study First Posted: 2024-01-17
• Study Start: 2024-01-31
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-18
• Primary Completion: 2025-04-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 96

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	AMT-253 for injection	AMT-253 Dose Escalation
Arm 2	AMT-253 for injection	AMT-253 Dose Expansion

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China