GEN1057 / Genmab - LARVOL DELTA

Trial to Assess the Safety and Antitumor Activity of GEN1057 in Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=45 | Recruiting | Sponsor: Genmab | Trial completion date: Jan 2026 ➔ Feb 2027 | Trial primary completion date: Sep 2025 ➔ Nov 2026

First-in-human • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Trial to Assess the Safety and Antitumor Activity of GEN1057 in Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=45 | Recruiting | Sponsor: Genmab | Trial completion date: Oct 2026 ➔ Jan 2026 | Trial primary completion date: Oct 2026 ➔ Sep 2025

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

Trial to Assess the Safety and Antitumor Activity of GEN1057 in Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=45 | Recruiting | Sponsor: Genmab | Trial completion date: Oct 2027 ➔ Oct 2026 | Trial primary completion date: Oct 2027 ➔ Oct 2026

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

DuoBody®-FAPαxDR4 induces tumor cell death through FAPα-dependent, DR4 transactivation-mediated apoptosis (AACR 2025) - P1 | "Here we present the novel Fc-silenced bispecific antibody DuoBody-FAPαxDR4 (GEN1057) designed to simultaneously bind to DR4 expressed on tumor cells and FAPα expressed on CAFs, to conditionally activate DR4 on the tumor cells...In vivo, DuoBody-FAPαxDR4 showed potent antitumor activity in PDX models and against multiorgan metastases in a CRC PDO cecum transplantation mouse model.In conclusion, DuoBody-FAPαxDR4 is a novel bispecific antibody that activates DR4 on cancer cells exclusively in the presence of FAPα-expressing cells, leading to targeted caspase activation and tumor cell death. DuoBody-FAPαxDR4 represents a promising therapeutic agent for the treatment of cancer and is currently under evaluation in a first-in-human trial in patients with solid tumors (NCT06573294)."

Tumor cell • Colorectal Cancer • Oncology • Solid Tumor • CAFs • CASP8 • FAP

Trial to Assess the Safety and Antitumor Activity of GEN1057 in Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=45 | Recruiting | Sponsor: Genmab | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

Trial to Assess the Safety and Antitumor Activity of GEN1057 in Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=45 | Not yet recruiting | Sponsor: Genmab

New P1 trial • Oncology • Solid Tumor