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

A phase 1/2 study of intravesical MK-3120 in participants with Bacillus Calmette-Guérin (BCG)-Naive or BCG-exposed high-risk non–muscle invasive bladder cancer (AUA 2026) - P1/2 | "Upon completion of the phase 1 portion and establishment of the recommended dose, a phase 2 dose expansion will be initiated. Recruitment is ongoing."

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

A Phase 1/2 Study of the Nectin-4–Directed Antibody-Drug Conjugate (ADC) MK-3120 in Participants (Pts) With Select Advanced Solid Tumors (ESMO 2026) - No abstract available

ADC • Clinical • Metastases • P1/2 data • Oncology • Solid Tumor

SKB410 for Injection in Solid Tumors (clinicaltrials.gov) - P1 | N=38 | Completed | Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Dec 2026 ➔ Mar 2026 | Trial primary completion date: Dec 2026 ➔ Mar 2026

Trial completion • Trial completion date • Trial primary completion date • Oncology • 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 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Jun 2030 ➔ Feb 2029 | Trial primary completion date: Jun 2030 ➔ Feb 2029

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

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

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

Preclinical evaluation of the nectin-4 antibody-drug conjugate MK-3120 (SKB410) in a panel of solid-tumor patient-derived xenograft models (AACR 2026) - "MK-3120 (SKB410) is a nectin-4-directed ADC with a unique, bifunctional linker that maximizes payload delivery to tumor cells both through its irreversible connection with a novel anti-nectin-4 monoclonal antibody and pH-sensitive cleavage from a belotecan-derived topo I inhibitor payload in the lysosome...In order to investigate differences in preclinical response biology, we tested enfortumab vedotin in parallel as a comparator ADC that targets the same antigen but delivers MMAE, a microtubule inhibitor...In the post-treatment analyses, nectin-4 protein expression (IHC H-score) and CNV showed no consistent, widespread changes after treatment with either ADC. Together, these data demonstrate overlapping but nonidentical responder sets indicating that payload and linker differences shape intrinsic ADC sensitivity, and that biomarker strategies should consider both antigen status and payload-relevant features."

ADC • Late-breaking abstract • Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • NECTIN4

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=68 ➔ 270

Enrollment change • Oncology • 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 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Recruiting | Trial completion date: Jun 2028 ➔ Jun 2030 | Trial primary completion date: Jun 2028 ➔ Jun 2030

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

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 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Oct 2030 ➔ Jul 2031 | Trial primary completion date: Oct 2030 ➔ Jul 2031

Trial completion date • Trial initiation date • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

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 | Recruiting | Sponsor: Merck Sharp & Dohme LLC

Trial initiation date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

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

Trial initiation date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

A clinical study of new treatments given with enfortumab vedotin and pembrolizumab in people with urothelial cancer (MK-3475-04D) (clinicaltrialsregister.eu) - P1/2 | N=16 | Recruiting | Sponsor: Merck Sharp & Dohme LLC

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

A clinical study of MK-3120 in people with bladder cancer (MK-3120-003) (clinicaltrialsregister.eu) - P1/2 | N=32 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

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

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 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

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

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