Phase 1b/2 study of BMS-813160, a CCR2/5 dual antagonist, in combination with chemotherapy or nivolumab in patients with advanced pancreatic or colorectal cancer.

Authors

• Dung T Le
• Gunnar Folprecht
• Anna M Varghese
• Martin Gutierrez
• Marcus Noel
• Nikolaos A Trikalinos
• Eric Chen
• Farshid Dayyani
• S Lindsey Davis
• Wen Wee Ma
• Atrayee BasuMallick
• Ignacio Garrido-Laguna
• Mayu Osawa
• Shaun O'Brien
• Ruslan D Novosiadly
• Ke Xu
• Danielle M Greenawalt
• Santanu Dutta
• Christina Twyman Saint Victor
• Heinz-Josef Lenz

Publication/Presentation Date

1-22-2026

Abstract

BACKGROUND: Cysteine-cysteine chemokine receptors 2 (CCR2) and 5 (CCR5) contribute to immune suppression in tumor microenvironments. CCR2 and CCR5 antagonists have demonstrated antitumor activity in pancreatic ductal adenocarcinoma (PDAC) and colorectal cancer (CRC), respectively. This phase 1b/2, open-label study evaluated BMS-813160, a CCR2/5 dual antagonist, in combination with chemotherapy±nivolumab in advanced PDAC or metastatic CRC.

METHODS: Part 1 included patients with metastatic untreated (first-line (1L)) PDAC, 1L CRC, or previously treated (second or third line (2/3L)) microsatellite stable (MSS) CRC. Patients received 2 weeks of BMS-813160 monotherapy (300 mg two times a day, 600 mg once daily, 300 mg once daily, or 150 mg once daily) and then BMS-813160+chemotherapy (gemcitabine+nab-paclitaxel (gem/nabP; 1L PDAC), 5-fluorouracil+leucovorin+irinotecan (FOLFIRI; 1L CRC)), or nivolumab (2/3L MSS CRC).Part 2 included patients with metastatic 1L PDAC or 2L CRC. Patients received BMS-813160 300 mg two times a day+gem/nabP±nivolumab (1L PDAC), BMS-813160 300 mg two times a day or 150 mg once daily+FOLFIRI (2L CRC), or chemotherapy alone. Primary endpoints were safety and pharmacodynamics (Part 1) and efficacy (Part 2).

RESULTS: In Part 1, 22 of 75 (29%) and 54 of 72 (72%) patients experienced a treatment-related adverse event during monotherapy lead-in and overall, respectively. Two dose-limiting toxicities (rash and pericardial effusion with pericarditis, both grade 3) occurred. In Part 2, patients with 1L PDAC who received BMS-813160 300 mg two times a day+gem/nabP+nivolumab achieved an overall response rate (ORR) of 37% (13/35); the median duration of response (DOR) was 45 weeks (95% CI 26.1 to not evaluable). ORRs with BMS-813160 300 mg two times a day+gem/nabP and gem/nabP alone were 26% (9/35) and 28% (9/32), respectively; median DORs were 121 and 31 weeks, respectively. Progression-free survival rates at 24 weeks were 56% (BMS-813160 300 mg two times a day+gem/nabP+nivolumab), 56% (BMS-813160 300 mg two times a day+gem/nabP), and 50% (gem/nabP). ORRs in 2L CRC were 19% (6/32; BMS-813160 300 mg two times a day+FOLFIRI), 13% (4/32; BMS-813160 150 mg once daily+FOLFIRI), and 27% (7/26; FOLFIRI).

CONCLUSIONS: In 1L PDAC, BMS-813160 300 two times a day+gem/nabP±nivolumab demonstrated durable antitumor response and was well tolerated. BMS-813160 combination regimens were tolerable in other cohorts, but clinical efficacy was not demonstrated.

TRIAL REGISTRATION NUMBER: NCT03184870.

Volume

14

Issue

1

ISSN

2051-1426

Published In/Presented At

Le DT, Folprecht G, Varghese AM, Gutierrez M, Noel M, Trikalinos NA, Chen E, Dayyani F, Davis SL, Ma WW, BasuMallick A, Garrido-Laguna I, Osawa M, O'Brien S, Novosiadly RD, Xu K, Greenawalt DM, Dutta S, Twyman Saint Victor C, Lenz HJ. Phase 1b/2 study of BMS-813160, a CCR2/5 dual antagonist, in combination with chemotherapy or nivolumab in patients with advanced pancreatic or colorectal cancer. J Immunother Cancer. 2026 Jan 22;14(1):e011284. doi: 10.1136/jitc-2024-011284. PMID: 41571299; PMCID: PMC12829384.

Disciplines

Medicine and Health Sciences

PubMedID

41571299

Department(s)

Hematology-Medical Oncology Division

Document Type

Article