AMT-116 ADC / Multitude Therap - LARVOL DELTA

Updated ongoing phase I/II clinical trial results of AMT-116, a first-in-class anti-CD44v9 antibody-drug conjugate (ADC), in patients with advanced solid tumors (ESMO 2025) - P1, P1/2 | "AMT-116 is a first-in-class antibody-drug conjugate (ADC) comprising a humanized anti-CD44v9 IgG1 antibody conjugated to KL610023, a novel belotecan-derived topoisomerase I inhibitor, via a cleavable hydrolysable linker (average drug-to-antibody ratio: 7–8). Conclusions AMT-116 demonstrated a manageable safety profile and promising antitumor activity across solid tumors especially in EGFR wild-type NSCLC. Enrollments are ongoing to further assess efficacy in NSCLC and other potential cancer types."

Clinical • Metastases • P1/2 data • Anal Carcinoma • Head and Neck Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • EGFR

Preliminary results from a first-in-human trial of AMT-116, a topoisomerase I inhibitor containing antibody-drug conjugate (ADC), in patients with advanced solid tumors. (ASCO 2024) - P1 | "AMT-116 is a first-in-class antibody-drug conjugate (ADC) targeting CD44v9, by conjugating a novel topoisomerase I inhibitor, belotecan derivative named KL610023 (Sichuan Kelun-Biotech) to a humanized anti-CD44v9 immunoglobulin G1 (IgG1) antibody via a hydrolysable linker with an average drug-to-antibody ratio of 7-8. These preliminary data indicate that AMT-116 is well tolerated at the first two dose levels in patients with heavily pretreated advanced solid tumors. Dose escalation is ongoing. Clinical trial information: NCT05725291."

Clinical • Metastases • P1 data • Anal Carcinoma • Cervical Cancer • Fatigue • Gastric Cancer • Gastrointestinal Cancer • Hematological Disorders • Hepatocellular Cancer • Leukopenia • Oncology • Solid Tumor • Squamous Cell Carcinoma

Global, Multicenter Study of AMT-116 Versus Investigator's Choice in Participants With Advanced or Metastatic Non-squamous EGFR-Wildtype Non-Small Cell Lung Cancer (NSCLC) With Progression on or After Platinum-Based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy (clinicaltrials.gov) - P2/3 | N=512 | Not yet recruiting | Sponsor: Multitude Therapeutics Inc.

New P2/3 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

AMT-116 in Combination With Ivosidan in Patients With Lung Cancer (clinicaltrials.gov) - P1/2 | N=118 | Recruiting | Sponsor: Multitude Therapeutics Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR

AMT-116 in Combination With Ivosidan in Patients With Lung Cancer (clinicaltrials.gov) - P1/2 | N=118 | Not yet recruiting | Sponsor: Multitude Therapeutics Inc.

New P1/2 trial • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR

Multitude Therapeutics Announces Promising Interim Phase I/II Results from the Ongoing First-in-Human Study Evaluating its CD44v9-directed Antibody-Drug-Conjugate, AMT-116, in Heavily Pretreated EGFR Wild-type Non-Small Cell Lung Cancer (NSCLC) and Other Advanced Solid Tumors at the 2025 ESMO Annual Meeting (PRNewswire) - "The overall response rate (ORR) was 40% (6/15), and the disease control rate (DCR) was 93% (14/15), in EGFR Wild-type NSCLC at dose levels >3 mg/kg. Among five EGFR Wild-type NSCLC patients at 5.0 mg/kg, ORR was 80% (4/5) and DCR was 100% (5/5). Preliminary antitumor activity was also observed in patients with NPC, anal carcinoma and salivary gland cancer at >3mg/kg, with ORRs of 50% (3/6), 60% (3/5) and 33% (2/6), respectively."

P1/2 data • Anal Carcinoma • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Salivary Gland Cancer

AMT-116 in Patients with Solid Tumors (clinicaltrials.gov) - P1/2 | N=144 | Recruiting | Sponsor: Multitude Therapeutics Inc.

New P1/2 trial • Oncology • Solid Tumor

AMT-116-01: AMT-116 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: Multitude Therapeutics Inc. | N=48 ➔ 80

Enrollment change • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

AMT-116 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Multitude Therapeutics Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

AMT-116 in Patients With Selected Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=48 | Not yet recruiting | Sponsor: Multitude Therapeutics Inc.

New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor