MK-3120 / Sichuan Kelun Pharma, Merck (MSD) - LARVOL DELTA

KEYMAKER-U04 Substudy 04D: A Clinical Study of New Treatments Given With Enfortumab Vedotin and Pembrolizumab in People With Urothelial Cancer (MK-3475-04D/KEYMAKER-U04) (clinicaltrials.gov) - P1/2 | N=55 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P1/2 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

A Study to Evaluate the Safety and Efficacy of MK-3120 in Participants With Advanced Solid Tumors (MK-3120-002) (clinicaltrials.gov) - P1/2 | N=270 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | N=180 ➔ 270 | Trial completion date: Jan 2028 ➔ Mar 2031 | Trial primary completion date: Jan 2028 ➔ Oct 2028

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

A Clinical Study of MK-3120 in People With Bladder Cancer (MK-3120-003) (clinicaltrials.gov) - P1/2 | N=45 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

A Clinical Study of MK-3120 in People With Bladder Cancer (MK-3120-003) (clinicaltrials.gov) - P1/2 | N=45 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P1/2 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

SKB410/MK-3120 (Nectin-4 ADC): (PRNewswire) - "Has shown promising Phase 1 clinical data. MSD, as the partner, has launched the global Phase 1/2 clinical trial of SKB410."

Trial status • Solid Tumor

SKB410 for Injection in Solid Tumors (clinicaltrials.gov) - P1 | N=54 | Active, not recruiting | Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. | N=276 ➔ 54 | Trial completion date: Jun 2025 ➔ Jun 2026 | Trial primary completion date: Jun 2025 ➔ Dec 2025

Enrollment change • Trial completion date • Trial primary completion date • Solid Tumor

KEYMAKER-U04 substudy 04A: A Substudy of Investigational Agents in Programmed Cell Death-1/Ligand 1 (PD-1/L1) Refractory Locally Advanced or Metastatic Urothelial Carcinoma (mUC) (MK-3475-04A) (clinicaltrials.gov) - P1/2 | N=48 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Oct 2027 ➔ May 2028 | Trial primary completion date: Oct 2027 ➔ May 2028

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

A Study to Evaluate the Safety and Efficacy of MK-3120 in Participants With Advanced Solid Tumors (MK-3120-002) (clinicaltrials.gov) - P1/2 | N=180 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

A Study to Evaluate the Safety and Efficacy of MK-3120 in Participants With Advanced Solid Tumors (MK-3120-002) (clinicaltrials.gov) - P1/2 | N=180 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P1/2 trial • Oncology • Solid Tumor

SKB410 for Injection in Solid Tumors (clinicaltrials.gov) - P1 | N=276 | Active, not recruiting | Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Oncology • Solid Tumor

SKB410 for Injection in Solid Tumors (clinicaltrials.gov) - P1 | N=276 | Recruiting | Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncology • Solid Tumor

Kelun-Biotech Announces Interim Results for 2023 (Yahoo Finance) - "Kelun-Biotech’s core product, SKB264, was granted a Breakthrough Therapy Designation (BTD) in January, 2023 by the National Medical Products Administration (NMPA) for EGFR-TKI failed EGFR-mutant locally advanced or metastatic NSCLC and another BTD in June for locally advanced or metastatic hormone receptor positive (HR)+/human epidermal growth factor receptor 2 negative (HER2-) breast cancer (BC) which has previously received at least 2L systemic chemotherapy...The phase Ia clinical trials of SKB410 for advanced solid tumors, which also received IND approval from the NMPA, successfully enrolled the first patient in July 2023."

Breakthrough therapy designation • Non-US regulatory • Trial status • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2

SKB410 for Injection in Solid Tumors (clinicaltrials.gov) - P1 | N=276 | Not yet recruiting | Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.

Metastases • New P1 trial • Oncology • Solid Tumor