GEN1047 / Genmab - LARVOL DELTA

GCT1047-01: GEN1047 for Solid Tumors - First in Human (FIH) Trial (clinicaltrials.gov) - P1/2 | N=179 | Terminated | Sponsor: Genmab | Active, not recruiting ➔ Terminated; The Sponsor has made a strategic decision to stop the development of GEN1047.

First-in-human • Trial termination • Breast Cancer • Endometrial Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

GCT1047-01: GEN1047 for Solid Tumors - First in Human (FIH) Trial (clinicaltrials.gov) - P1/2 | N=179 | Active, not recruiting | Sponsor: Genmab | Trial completion date: Mar 2027 ➔ Dec 2025 | Trial primary completion date: Jan 2027 ➔ Dec 2025

Trial completion date • Trial primary completion date • Breast Cancer • Endometrial Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

GCT1047-01: GEN1047 for Solid Tumors - First in Human (FIH) Trial (clinicaltrials.gov) - P1/2 | N=179 | Active, not recruiting | Sponsor: Genmab | Recruiting ➔ Active, not recruiting | N=400 ➔ 179

Enrollment change • Enrollment closed • Breast Cancer • Endometrial Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

GCT1047-01: GEN1047 for Solid Tumors - First in Human (FIH) Trial (clinicaltrials.gov) - P1/2 | N=400 | Recruiting | Sponsor: Genmab | Trial completion date: Jun 2026 ➔ Mar 2027 | Trial primary completion date: Jan 2026 ➔ Jan 2027

Trial completion date • Trial primary completion date • Breast Cancer • Endometrial Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

GCT1047-01: GEN1047 for Solid Tumors - First in Human (FIH) Trial (clinicaltrials.gov) - P1/2 | N=500 | Recruiting | Sponsor: Genmab | Trial completion date: Aug 2025 ➔ Jun 2026 | Trial primary completion date: Jan 2025 ➔ Jan 2026

Trial completion date • Trial primary completion date • Breast Cancer • Endometrial Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

GCT1047-01: GEN1047 for Solid Tumors - First in Human (FIH) Trial (clinicaltrials.gov) - P1/2 | N=500 | Recruiting | Sponsor: Genmab | N=220 ➔ 500 | Trial completion date: Jan 2025 ➔ Aug 2025

Enrollment change • Trial completion date • Breast Cancer • Endometrial Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

Preclinical mechanism of action and pharmacodynamic biomarker studies of DuoBody-CD3xB7H4 in solid cancer models (SITC 2022) - P1/2 | "Currently, DuoBody-CD3xB7H4 is being investigated in a first-in-human clinical trial for the treatment of solid tumors known to express B7H4 ( NCT05180474 ), in which the MoA and PD, including biomarkers of response, will be clinically explored. Ethics Approval Animal experiments were performed according to the guidelines of the Institutional Animal Care and Use Committee (IACUC) and in accordance with the regulations of the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC)."

PK/PD data • Preclinical • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • GZMB • VTCN1

Research Trial to Study Safety of GEN1047 (DuoBody®-CD3xB7H4) in Participants With Malignant Solid Tumors (clinicaltrials.gov) - P1/2; N=220; Recruiting; Sponsor: Genmab

Clinical • New P1/2 trial • Biliary Cancer • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer • Uterine Cancer • MUC16

In vitro and in vivo studies establish DuoBody®-CD3xB7H4 as a novel drug candidate for the treatment of solid cancers (SITC 2021) - "Repeated dosing of DuoBody-CD3xB7H4 in cynomolgus monkeys confirmed an acceptable safety profile up to the maximal dose tested (30 mg/kg). Conclusions These studies describe the preclinical development of DuoBody-CD3xB7H4, a bsAb that induces T-cell mediated cytotoxicity of B7H4-positive tumor cells, which may provide an alternative therapeutic modality in the immune-oncology space for patients with solid cancers."

IO biomarker • Preclinical • Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • IL6 • PD-L1 • VTCN1

Genmab Announces Abstracts Evaluating Investigational Solid Tumor Therapies to be Presented at the Society for Immunotherapy of Cancer’s 36th Annual Meeting (SITC 2021) (Businesswire) - "Genmab A/S...announced today that multiple abstracts evaluating several investigational therapies and technologies in the company’s solid tumor product pipeline will be presented at the Society for Immunotherapy of Cancer’s 36th Annual Meeting (SITC 2021), being held in Washington, DC, and virtually, November 10-14. The presentations will include a mini-oral session featuring the results of the first-in-human (FIH) phase 1/2 trial evaluating the safety and initial clinical activity of the investigational bispecific antibody, DuoBody®-CD40×4-1BB (GEN1042), in patients with advanced solid tumors. Data from another FIH phase 1/2a trial, evaluating the investigational bispecific antibody, DuoBody®-PD-L1×4-1BB (GEN1046) in patients with advanced solid tumors, will be presented as a poster. In addition, four posters will be presented, including one evaluating DuoBody®-CD3xB7H4 (GEN1047)..."

Clinical data • Oncology • Solid Tumor