RC148 / Rongchang Pharma - LARVOL DELTA

Efficacy and safety of disitamab vedotin in combination with RC148 versus albumin-bound paclitaxel ± toripalimab for patients with HR-negative HER2-low-expressing unresectable locally advanced or metastatic breast cancer: An open-label, randomized, controlled phase II study. (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT06642545 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Combination therapy • Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

A Phase Ib Study of RC148 as Monotherapy or Combination for Locally Advanced or Metastatic NSCLC (clinicaltrials.gov) - P1 | N=150 | Recruiting | Sponsor: RemeGen Co., Ltd. | Not yet recruiting ➔ Recruiting

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

A Phase Ib Study of RC148 as Monotherapy or Combination for Locally Advanced or Metastatic NSCLC (clinicaltrials.gov) - P1 | N=150 | Not yet recruiting | Sponsor: RemeGen Co., Ltd.

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

A Study of RC148 As a Single Agent and Combination Therapy in Patients with Locally Advanced Unresectable or Metastatic Malignant Solid Tumors (clinicaltrials.gov) - P1/2 | N=221 | Recruiting | Sponsor: RemeGen Co., Ltd. | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial primary completion date • Gastric Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-1

Efficacy and Safety Study of Disitamab Vedotin + RC148 vs. Albumin-Paclitaxone ± Toripalimab in HR-/HER2-low Breast Cancer (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: RemeGen Co., Ltd. | Not yet recruiting ➔ Recruiting | Initiation date: Nov 2024 ➔ Feb 2025

Enrollment open • Trial initiation date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor

A Study of RC148 As a Single Agent and Combination Therapy in Patients with Locally Advanced Unresectable or Metastatic Malignant Solid Tumors (clinicaltrials.gov) - P1/2 | N=221 | Recruiting | Sponsor: RemeGen Co., Ltd. | Phase classification: P1 ➔ P1/2 | N=25 ➔ 221

Enrollment change • Phase classification • Gastric Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-1

Efficacy and Safety Study of Disitamab Vedotin + RC148 vs. Albumin-Paclitaxone ± Toripalimab in HR-/HER2-low Breast Cancer (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: RemeGen Co., Ltd.

Combination therapy • Metastases • New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor

RC148, a novel bispecific antibody targeting PD-1 and VEGF for cancer immunotherapy (AACR 2024) - "RC148 allows dimeric VEGF crosslinking and gradually enhances PD-1 binding activity, potentially reduces systemic toxicity of anti-VEGF therapy and enhances antitumor potency via VEGF trigged enrichment in tumor areas. In preclinical studies, RC148 blocks the binding of VEGF to VEGFR and PD-1 to PD-L1, prevents the growth and migration of human umbilical vein endothelial cells, enables efficient T cell activation, exhibited synergistic antitumor effects in rodent models and showed safety profiles in non-human primate studies."

Oncology

A Study of RC148 in Patients With Locally Advanced Unresectable or Metastatic Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=25 | Recruiting | Sponsor: RemeGen Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncology • Solid Tumor • PD-1