imzokitug (BMS-986340) / BMS, Ono Pharmaceutical - LARVOL DELTA

Phase 2, Single-arm Trial of BMS-986340 in Association With Nivolumab, Trifluridine/Tipiracil and Bevacizumab for Patients Refractory to Standard of Care Treatment and With Microsatellite-stable Colorectal Cancer (clinicaltrials.gov) - P2 | N=7 | Suspended | Sponsor: M.D. Anderson Cancer Center | N=40 ➔ 7 | Initiation date: Nov 2025 ➔ Aug 2025 | Recruiting ➔ Suspended

Enrollment change • Trial initiation date • Trial suspension • Colorectal Cancer • Oncology • Solid Tumor

BMS-986340 in Combination With Nivolumab, Gemcitabine and Nab-paclitaxel for the Treatment of Metastatic and Recurrent Pancreatic Adenocarcinoma (clinicaltrials.gov) - P2 | N=43 | Recruiting | Sponsor: Mayo Clinic | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

BMS-986340 in Combination With Nivolumab, Gemcitabine and Nab-paclitaxel for the Treatment of Metastatic and Recurrent Pancreatic Adenocarcinoma (clinicaltrials.gov) - P2 | N=43 | Not yet recruiting | Sponsor: Mayo Clinic

New P2 trial • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

CA052-002: A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=949 | Recruiting | Sponsor: Bristol-Myers Squibb | Trial completion date: Dec 2026 ➔ Jul 2028 | Trial primary completion date: Dec 2025 ➔ Jul 2028

Monotherapy • Trial completion date • Trial primary completion date • Breast Cancer • Cervical Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Head and Neck Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer

Phase 2, Single-arm Trial of BMS-986340 in Association With Nivolumab, Trifluridine/Tipiracil and Bevacizumab for Patients Refractory to Standard of Care Treatment and With Microsatellite-stable Colorectal Cancer (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Not yet recruiting ➔ Recruiting

Enrollment open • Colorectal Cancer • Oncology • Solid Tumor

Phase 2, Single-arm Trial of BMS-986340 in Association With Nivolumab, Trifluridine/Tipiracil and Bevacizumab for Patients Refractory to Standard of Care Treatment and With Microsatellite-stable Colorectal Cancer (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: M.D. Anderson Cancer Center

New P2 trial • Colorectal Cancer • Oncology • Solid Tumor

A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=905 | Recruiting | Sponsor: Bristol-Myers Squibb | N=665 ➔ 905 | Trial completion date: Sep 2026 ➔ Dec 2026 | Trial primary completion date: Apr 2025 ➔ Dec 2025

Combination therapy • Enrollment change • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Breast Cancer • Cervical Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Head and Neck Cancer • Hepatology • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer

Developing personalized immunotherapy strategies using an ex vivo tumor fragment platform (EACR 2024) - "We cultured PDTFs from four cancer types (kidney, lung, skin, ovary) that were either left untreated or exposed to different agents including anti-PD-1 (nivolumab), anti-LAG3 (relatlimab), anti-ILT4 (BMS-986406), anti-CCR8 (BMS-986340) and/or JNK inhibitor (BMS-986360). Whereas in some tumors single or dual checkpoint blockade could enhance immune activity, most tumors required targeting of additional pathways to overcome immune resistance. Notably, individual tumors showed response to distinct treatment combinations, highlighting the need for developing personalized immunotherapy strategies.Conclusion Translational studies using patient-derived tumor models may help to identify rational immunotherapy combinations overcoming anti-PD-1 resistance and their biomarkers, and to prioritize them for clinical development."

IO biomarker • Preclinical • Oncology • CCR8

Developing personalized immunotherapy strategies using an ex vivo tumor fragment platform (EACR 2024) - "We cultured PDTFs from four cancer types (kidney, lung, skin, ovary) that were either left untreated or exposed to different agents including anti-PD-1 (nivolumab), anti-LAG3 (relatlimab), anti-ILT4 (BMS-986406), anti-CCR8 (BMS-986340) and/or JNK inhibitor (BMS-986360). Whereas in some tumors single or dual checkpoint blockade could enhance immune activity, most tumors required targeting of additional pathways to overcome immune resistance. Notably, individual tumors showed response to distinct treatment combinations, highlighting the need for developing personalized immunotherapy strategies.Conclusion Translational studies using patient-derived tumor models may help to identify rational immunotherapy combinations overcoming anti-PD-1 resistance and their biomarkers, and to prioritize them for clinical development."

IO biomarker • Preclinical • Oncology • CCR8

Enhancing the therapeutic responses of anti-human CCR8 mAbs utilizing the fully humanized CCR8 knockin mice (SITC 2023) - "Then, the binding and EC50 of BMS-986340 and anti-hCCR8 (BD, clone 433H) was determined by FACS using the activated splenocytes from hCCR8 (v2) knockin mice by anti-mCD3/anti-mCD28...We observed the tumor-resident CCR8+ Treg populations decreased significantly and CD4+/CD8+ T cells proliferation as well as PD-1 upregulation in CD4+/CD8+ T cells 24h post 6th dose. Conclusions The hCCR8(v2) mouse model is a more suitable preclinical humanized model distinguished with the previous hCCR8(v1) mouse model, enabling the in vivo evaluation of various human-specific CCR8 mAbs alone or in combination with immune checkpoint inhibitors like PD-1 and CTLA-4."

IO biomarker • Preclinical • Oncology • Solid Tumor • CCR8 • CD4 • CD8

A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=665 | Recruiting | Sponsor: Bristol-Myers Squibb | N=185 ➔ 665 | Trial completion date: Aug 2025 ➔ Sep 2026 | Trial primary completion date: Mar 2024 ➔ Apr 2025

Combination therapy • Enrollment change • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Breast Cancer • Cervical Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Head and Neck Cancer • Hepatology • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer

A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2; N=185; Recruiting; Sponsor: Bristol-Myers Squibb; Not yet recruiting ➔ Recruiting

Enrollment open • Cervical Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2; N=185; Not yet recruiting; Sponsor: Bristol-Myers Squibb

Combination therapy • Monotherapy • New P1/2 trial • Cervical Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck