AMT-116 in Patients with Solid Tumors

NCT06782334 | Recruiting Phase 1

• 1 other identifier: AMT-116-02
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of AMT-116 monotherapy in subjects with advanced solid tumors. The study is divided into two parts: the part I is dose escalation and the Part Ⅱ for expansion.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (4)

• Phase I: Maximum Tolerated Dose(MTD) and the Recommended Phase 2 Dose(RP2D) of AMT-116

  The MTD（Maximum Tolerated Dose） and RP2D（Recommended Phase 2 Dose） will be determined for expansion using dose limiting toxicities (DLTs) and all other available study data

  approximately 12 months

• Phase I: Type, incidence and severity of Adverse Events,Dose Limiting Toxicities (DLTs)

  Assess safety and tolerability of AMT-116 by the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) version 5.0

  approximately 12 months

• Phase II: Objective Response Rate(ORR)

  To evaluate the objective response rate (ORR) \[Complete Response (CR) + Partial Response (PR)\] according to the RECIST v1.1

  approximately 18 months

• Phase II: Type, incidence and severity of Adverse Events

  Assess safety and tolerability of AMT-116 by the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) version 5.0

  approximately 18 months

Secondary Outcomes (19)

• Phase I: Overall Response Rate (ORR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

  approximately 12 months

• Phase I Disease Control Rate (DCR) according to the RECIST v1.1

  approximately 12 months

• Phase I: Progression-free Survival (PFS)

  approximately 12 months

• Phase I: Levels of target expression or Tumor Infiltrating Lymphocyte in tumor tissue

  approximately 12 months

• Phase I: Concentration of anti-drug antibodies (ADA)

  approximately 12 months

Study Arms (2)

Phase I: Dose escalation

EXPERIMENTAL

Five dose levels in the Phase I part of the study

Drug: AMT-116

Phase II: Dose Expansion

OTHER

Patients in phase II will be enrolled based on the RP2D (Recommended Phase 2 Dose) determined from phase I dose escalation data.

Drug: AMT-116

Interventions

AMT-116 DRUG

AMT-116 is an antibody Drug Conjugate (ADC)

Phase I: Dose escalation; Phase II: Dose Expansion

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 histologically confirmed, unresectable advanced solid tumor. Preferred tumor types include non-small cell lung, head and neck, esophageal, cervical, breast, bladder, gastric, biliary tract, skin squamous cell, liver, and basal cell cancer.
• 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.
• The anticipated survival duration is no less than three months.
• Patients must have adequate organ function
• Women of child-bearing potential (WCBP) must consent to the use of two effective contraceptive methods during the study treatment period and for at least 12 weeks after the final administration of IMP
• Women of child-bearing potential (WCBP) must have a negative serum pregnancy test within seven days preceding the initial administration of the investigational medicinal product (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 12 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 tumour tissue sample (either an archival specimen or a fresh biopsy material) at screening.

You may not qualify if:

• Prior therapy with ADC based on Top1 inhibitor.
• 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.
• Active ocular conditions requiring treatment or close monitoring, including, but not limited to: macular degeneration, papilledema, active diabetic retinopathy with macular oedema, wet age-related macular degeneration requiring intravitreal injections, or uncontrolled glaucoma.
• 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 (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 the first dose of the IMP, or no recovery from side effects of such intervention.
• Significant cardiac disease, such as recent (within six 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, 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.).
• 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 virus (HBV), hepatitis C virus (HCV), and 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 enzyme (CYP3A4) within 2 weeks prior to the first dose and during the study treatment.

Sponsors & Collaborators

• Multitude Therapeutics Inc.: lead

Study Sites (7)

Fujian Cancer Hospital

Fuzhou, Fujian, China

RECRUITING

Dongguan People's Hospital

Dongguan, Guangdong, China

NOT YET RECRUITING

Zhujiang Hospital of Southern Medical University(The Second Clinical Medical College)

Guangzhou, Guangdong, China

RECRUITING

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, China

RECRUITING

Zhejiang cancer hospital

Hangzhou, Zhejiang, China

RECRUITING

The Second Affiliated Hospital and Yuying Childrens Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

RECRUITING

Central Study Contacts

Yixuan Wang

CONTACT

+86-021-33560023; yixuan.wang@multitudetherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: January 17, 2025
• Study Start: May 7, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 17, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)