AMT-253 ADC / Multitude Therap - LARVOL DELTA

Multitude Therapeutics Announces Encouraging Interim Phase I/II Results from Ongoing First-in-Human Study Evaluating its MUC18-directed Antibody-Drug-Conjugate, AMT-253, in Melanoma and Other Advanced Solid Tumors at the 2025 ESMO Annual Meeting (PRNewswire) - "In heavily pretreated melanoma patients, with prior lines of therapy ranging from 1-7, promising efficacy was observed without MUC18 preselection. The overall response rate (ORR) was 28.6% in all melanomas (16/56, 15 confirmed, 1 unconfirmed still on-treatment) across all dose levels. In melanoma patients without prior chemotherapy, ORR was 35% (7/20, all confirmed), 50% (5/10; 4 confirmed, 1 unconfirmed still on-treatment), and 33.3% (1/3, confirmed) for the cutaneous, acral, and mucosal subtypes, respectively; preliminary mPFS was 8.6, 8.3, and 11.0 months...Preliminary antitumor activity was also observed in endometrial cancer, cervical squamous carcinoma and uterine leiomyosarcoma patients."

P1 data • Cervical Squamous Cell Carcinoma • Endometrial Cancer • Melanoma • Uterine Leiomyosarcoma

Ongoing phase I trial results of AMT-253, a first-in-class MUC18-targeting antibody-drug conjugate in patients with melanoma and other advanced solid tumors (ESMO 2025) - P1, P1/2 | "Conclusions AMT-253 demonstrated a manageable safety profile and promising activity in melanoma and gynecological cancers. Expansion cohorts are actively enrolling to further investigate efficacy in selected solid tumors."

Clinical • IO biomarker • Metastases • P1 data • Endometrial Cancer • Gynecologic Cancers • Leiomyosarcoma • Melanoma • Oncology • Sarcoma • Solid Tumor • Uterine Leiomyosarcoma • MCAM

AMT-253 in Patients With Advanced Solid Tumours (clinicaltrials.gov) - P1/2 | N=96 | Recruiting | Sponsor: Multitude Therapeutics Inc. | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Apr 2025 ➔ Apr 2026

Trial completion date • Trial primary completion date • Melanoma • Oncology • Solid Tumor

AMT-253 in Patients With Selected Advanced Solid Tumours (clinicaltrials.gov) - P1 | N=54 | Recruiting | Sponsor: Multitude Therapeutics (Australia) Pty Ltd | Trial completion date: Feb 2026 ➔ Dec 2026 | Trial primary completion date: Oct 2025 ➔ Sep 2026

Trial completion date • Trial primary completion date • Solid Tumor

A cell surface-binding antibody atlas nominates a MUC18-directed antibody-drug conjugate for targeting melanoma (Clin Cancer Res) - "AMT-253 exhibited MUC18-specific cytotoxicity through DNA damage and apoptosis and a strong bystander killing effect, leading to potent antitumor activities against melanoma cell line and patient-derived xenograft models. Tumor vasculature-targeting by a mouse MUC18-specific antibody-T1000-exatecan conjugate inhibited tumor growth in human melanoma xenografts."

Preclinical • Melanoma