AMT-562 in Patients With Selected Advanced Solid Tumors

NCT06199908 | Unknown Phase 1

• 1 other identifier: AMT-562-01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief Summary

This is a first-in-human, non-randomized, open-label, multicenter Phase 1 study of AMT-562 in patients with advanced solid tumors.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (3)

• DLTs

  Incidence of dose limiting toxicities

  up to 24 month

• AEs

  Type, incidence and severity of Adverse Events

  up to 24 month

• SAEs

  Type, incidence and severity Serious Adverse Events (SAEs)

  up to 24 month

Secondary Outcomes (10)

• Cmax

  up to 24 month

• Tmax

  up to 24 month

• AUC

  up to 24 month

• t1/2

  up to 24 month

• ADAs

  up to 24 month

Study Arms (1)

Arm 1

EXPERIMENTAL

AMT-562 Dose Escalation

Drug: AMT-562

Interventions

AMT-562 DRUG

Administered AMT-562 for injection intravenously

Arm 1

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 understand and 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 histologically confirmed unresectable advanced solid tumor.
• \. 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.
• \. 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), 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 (i.e., who has had menses any time in the preceding 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.
• \. WCBP must have a negative serum pregnancy test within 7 days prior to first dose of the IMP.
• \. 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.
• \. 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.
• \. Availability of tumor tissue sample (either an archival specimen or a fresh biopsy material) at screening.

You may not qualify if:

• \. Central nervous system (CNS) metastasis.
• \. Active or chronic skin disorder requiring systemic therapy.
• \. 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 or 21 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 within 28 days.
• \. Major surgery within 28 days prior to first dose of the IMP, or no recovery from side effects of such intervention.
• \. Significant cardiac disease.
• \. Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis t.
• \. 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 3A 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 (Australia) Pty Ltd: lead

Study Sites (2)

Macquarie University Hospital

North Ryde, New South Wales, Australia

RECRUITING

Cabrini Malvern Hospital

Malvern, Victoria, Australia

RECRUITING

Central Study Contacts

Minqi Guan

CONTACT

86-15895820062; minqi.guan@multitudetherapeutics.com

Study Design

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

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 10, 2024
• Study Start: May 20, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 26, 2024

Record last verified: 2023-12

Locations

AU (2)