NM32-2668 / Numab - LARVOL DELTA

A phase 1 trial of NM32-2668, a ROR1-CD3-HSA trispecific T-cell engager in patients with ROR1-expressing solid tumors (SITC 2025) - "In line with previous therapies targeting ROR1 in solid tumors, limited efficacy was observed, potentially due to ROR1 expression that was more heterogeneous than for targets where T-cell engagers have had clinical success.Trial Registration Clinicaltrials.gov NCT06299163Ethics Approval This study was approved by Ethics and Institutional Review Boards (IRBs) at all study sites. IRB reference numbers: WCG1340057 (Carolina BioOncology, Gabrail Cancer Center, University of Wisconsin Carbone Cancer Center, Samuel Oschin Cancer Center/Cedars-Sinai Medical Center, Winship Cancer Institute/Emory University, Northwest Medical Specialties/Tacoma Medical Oncology), Advarra MCC# 22112 (Moffitt Cancer Center), BRANY 22-06-326-01 (Albert Einstein Cancer Center), IRB00349569 (Johns Hopkins University School of Medicine), 2022-0761 (The University of Texas MD Anderson Cancer Center), UHIRB STUDY20221273 (UH Cleveland Medical center, Seidman Cancer Center)."

Clinical • P1 data • Trispecific • Esophageal Cancer • Kidney Cancer • Leiomyosarcoma • Mesothelioma • Multiple Myeloma • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Sarcoma • Solid Tumor • CD3E • ROR1

NM32-2668 in Adult Patients With Selected Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=11 | Terminated | Sponsor: Numab Therapeutics AG | N=180 ➔ 11 | Trial completion date: Dec 2027 ➔ Apr 2025 | Active, not recruiting ➔ Terminated | Trial primary completion date: Dec 2027 ➔ Apr 2025; Business decision

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Breast Cancer • Endometrial Cancer • Esophageal Cancer • Fallopian Tube Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Genito-urinary Cancer • Leiomyosarcoma • Liposarcoma • Lung Adenocarcinoma • Lung Cancer • Melanoma • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Renal Cell Carcinoma • Sarcoma • Solid Tumor • Triple Negative Breast Cancer

NM32-2668 in Adult Patients With Selected Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=180 | Active, not recruiting | Sponsor: Numab Therapeutics AG | Recruiting ➔ Active, not recruiting

Enrollment closed • Breast Cancer • Endometrial Cancer • Esophageal Cancer • Fallopian Tube Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Genito-urinary Cancer • Leiomyosarcoma • Liposarcoma • Lung Adenocarcinoma • Lung Cancer • Melanoma • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Renal Cell Carcinoma • Sarcoma • Solid Tumor • Triple Negative Breast Cancer

Numab Therapeutics Announces Initiation of Phase 1 Clinical Study of NM32 Program in Patients with Solid Tumors (GlobeNewswire) - "Numab Therapeutics AG...announced today the start of a Phase 1 clinical trial evaluating NM32....It is planned to enroll up to 60 patients with solid tumors overexpressing ROR1 from major clinical sites across the United States."

Trial status • Oncology • Solid Tumor

NM32-2668 in Adult Patients With Selected Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=180 | Recruiting | Sponsor: Numab Therapeutics AG

Metastases • New P1 trial • Trispecific • Breast Cancer • Endometrial Cancer • Esophageal Cancer • Fallopian Tube Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Leiomyosarcoma • Liposarcoma • Lung Adenocarcinoma • Lung Cancer • Melanoma • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Renal Cell Carcinoma • Sarcoma • Solid Tumor • Triple Negative Breast Cancer

Establishing the preclinical PKPD relationship for NM32-2668 a ROR1 targeting T cell engager (SITC 2022) - "Conclusions A PK-PD-Efficacy model based on the in vitro data was established showing that the cytotoxicity response was strongly correlated to ROR1 expression and CD8 activation. Building on this in vitro model, we developed an in vivo PK-TGI model that can link immune system activation to TGI."

Preclinical • Oncology • CD4 • CD8 • ROR1