COMPANION-002 A clinical trial of investigational drug CTX-009 plus paclitaxel vs paclitaxel in second line advanced BTC

Nilofer Azad; Zishuo Hu; Ilyas Sahin; Renuka Iyer; Olivia Aranha; Howard Hochster; Priyadarshini Pathak; Andrew Scott Paulson; Aparna Kalyan; Chih Yi Liao; Nguyen Tran; Robin K. Kelley; Gregory Heestand; David Cosgrove; Anthony El-Khoueiry; Mitesh Borad; Nashat Y. Gabrail; Umair Majeed; Lingling Du; Suneel Kamath; Nathan Shumway; Rachna Shroff; Lipika Goyal; Minori Rosales; Milind Javle

doi:10.1080/14796694.2024.2351351

COMPANION-002 A clinical trial of investigational drug CTX-009 plus paclitaxel vs paclitaxel in second line advanced BTC

Nilofer Azad, Zishuo Hu, Ilyas Sahin, Renuka Iyer, Olivia Aranha, Howard Hochster, Priyadarshini Pathak, Andrew Scott Paulson, Aparna Kalyan, Chih Yi Liao, Nguyen Tran, Robin K. Kelley, Gregory Heestand, David Cosgrove, Anthony El-Khoueiry, Mitesh Borad, Nashat Y. Gabrail, Umair Majeed, Lingling Du, Suneel KamathNathan Shumway, Rachna Shroff, Lipika Goyal, Minori Rosales^*, Milind Javle

^*Corresponding author for this work

Medicine, Hematology Oncology Division

Research output: Contribution to journal › Article › peer-review

Abstract

Treatment options for patients with biliary tract cancer are limited, and the prognosis is poor. CTX-009, a novel bispecific antibody targeting both DLL4 and VEGF-A, has demonstrated antitumor activity in patients with advanced cancers as both a monotherapy and in combination with chemotherapy. In a phase II study of patients with advanced biliary tract cancer who had received one or two prior therapies, CTX-009 with paclitaxel demonstrated a 37.5% overall response rate (ORR). Described here is the design of and rationale for COMPANION-002, a randomized phase II/III study, which will evaluate the safety and efficacy of CTX-009 in combination with paclitaxel versus paclitaxel alone as second-line treatment for patients with advanced biliary tract cancer. The primary end point is ORR, and crossover is allowed. Clinical Trial Registration:NCT05506943 (ClinicalTrials.gov).

Original language	English (US)
Pages (from-to)	2241-2248
Number of pages	8
Journal	Future Oncology
Volume	20
Issue number	30
DOIs	https://doi.org/10.1080/14796694.2024.2351351
State	Published - 2024

Keywords

CTX-009
DLL4
Paclitaxel
VEGF
anti-angiogenesis
biliary tract cancer
cholangiocarcinoma
clinical trial

ASJC Scopus subject areas

Oncology
Cancer Research

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1080/14796694.2024.2351351

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Azad, N., Hu, Z., Sahin, I., Iyer, R., Aranha, O., Hochster, H., Pathak, P., Paulson, A. S., Kalyan, A., Liao, C. Y., Tran, N., Kelley, R. K., Heestand, G., Cosgrove, D., El-Khoueiry, A., Borad, M., Gabrail, N. Y., Majeed, U., Du, L., ... Javle, M. (2024). COMPANION-002 A clinical trial of investigational drug CTX-009 plus paclitaxel vs paclitaxel in second line advanced BTC. Future Oncology, 20(30), 2241-2248. https://doi.org/10.1080/14796694.2024.2351351

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title = "COMPANION-002 A clinical trial of investigational drug CTX-009 plus paclitaxel vs paclitaxel in second line advanced BTC",

abstract = "Treatment options for patients with biliary tract cancer are limited, and the prognosis is poor. CTX-009, a novel bispecific antibody targeting both DLL4 and VEGF-A, has demonstrated antitumor activity in patients with advanced cancers as both a monotherapy and in combination with chemotherapy. In a phase II study of patients with advanced biliary tract cancer who had received one or two prior therapies, CTX-009 with paclitaxel demonstrated a 37.5% overall response rate (ORR). Described here is the design of and rationale for COMPANION-002, a randomized phase II/III study, which will evaluate the safety and efficacy of CTX-009 in combination with paclitaxel versus paclitaxel alone as second-line treatment for patients with advanced biliary tract cancer. The primary end point is ORR, and crossover is allowed. Clinical Trial Registration:NCT05506943 (ClinicalTrials.gov).",

keywords = "CTX-009, DLL4, Paclitaxel, VEGF, anti-angiogenesis, biliary tract cancer, cholangiocarcinoma, clinical trial",

author = "Nilofer Azad and Zishuo Hu and Ilyas Sahin and Renuka Iyer and Olivia Aranha and Howard Hochster and Priyadarshini Pathak and Paulson, {Andrew Scott} and Aparna Kalyan and Liao, {Chih Yi} and Nguyen Tran and Kelley, {Robin K.} and Gregory Heestand and David Cosgrove and Anthony El-Khoueiry and Mitesh Borad and Gabrail, {Nashat Y.} and Umair Majeed and Lingling Du and Suneel Kamath and Nathan Shumway and Rachna Shroff and Lipika Goyal and Minori Rosales and Milind Javle",

note = "Publisher Copyright: {\textcopyright} 2024 Compass Therapeutics LLC. Published by Informa UK Limited, trading as Taylor & Francis Group.",

year = "2024",

doi = "10.1080/14796694.2024.2351351",

language = "English (US)",

volume = "20",

pages = "2241--2248",

journal = "Future Oncology",

issn = "1479-6694",

publisher = "Taylor and Francis Ltd.",

number = "30",

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Azad, N, Hu, Z, Sahin, I, Iyer, R, Aranha, O, Hochster, H, Pathak, P, Paulson, AS, Kalyan, A, Liao, CY, Tran, N, Kelley, RK, Heestand, G, Cosgrove, D, El-Khoueiry, A, Borad, M, Gabrail, NY, Majeed, U, Du, L, Kamath, S, Shumway, N, Shroff, R, Goyal, L, Rosales, M & Javle, M 2024, 'COMPANION-002 A clinical trial of investigational drug CTX-009 plus paclitaxel vs paclitaxel in second line advanced BTC', Future Oncology, vol. 20, no. 30, pp. 2241-2248. https://doi.org/10.1080/14796694.2024.2351351

TY - JOUR

T1 - COMPANION-002 A clinical trial of investigational drug CTX-009 plus paclitaxel vs paclitaxel in second line advanced BTC

AU - Azad, Nilofer

AU - Hu, Zishuo

AU - Sahin, Ilyas

AU - Iyer, Renuka

AU - Aranha, Olivia

AU - Hochster, Howard

AU - Pathak, Priyadarshini

AU - Paulson, Andrew Scott

AU - Kalyan, Aparna

AU - Liao, Chih Yi

AU - Tran, Nguyen

AU - Kelley, Robin K.

AU - Heestand, Gregory

AU - Cosgrove, David

AU - El-Khoueiry, Anthony

AU - Borad, Mitesh

AU - Gabrail, Nashat Y.

AU - Majeed, Umair

AU - Du, Lingling

AU - Kamath, Suneel

AU - Shumway, Nathan

AU - Shroff, Rachna

AU - Goyal, Lipika

AU - Rosales, Minori

AU - Javle, Milind

PY - 2024

Y1 - 2024

N2 - Treatment options for patients with biliary tract cancer are limited, and the prognosis is poor. CTX-009, a novel bispecific antibody targeting both DLL4 and VEGF-A, has demonstrated antitumor activity in patients with advanced cancers as both a monotherapy and in combination with chemotherapy. In a phase II study of patients with advanced biliary tract cancer who had received one or two prior therapies, CTX-009 with paclitaxel demonstrated a 37.5% overall response rate (ORR). Described here is the design of and rationale for COMPANION-002, a randomized phase II/III study, which will evaluate the safety and efficacy of CTX-009 in combination with paclitaxel versus paclitaxel alone as second-line treatment for patients with advanced biliary tract cancer. The primary end point is ORR, and crossover is allowed. Clinical Trial Registration:NCT05506943 (ClinicalTrials.gov).

AB - Treatment options for patients with biliary tract cancer are limited, and the prognosis is poor. CTX-009, a novel bispecific antibody targeting both DLL4 and VEGF-A, has demonstrated antitumor activity in patients with advanced cancers as both a monotherapy and in combination with chemotherapy. In a phase II study of patients with advanced biliary tract cancer who had received one or two prior therapies, CTX-009 with paclitaxel demonstrated a 37.5% overall response rate (ORR). Described here is the design of and rationale for COMPANION-002, a randomized phase II/III study, which will evaluate the safety and efficacy of CTX-009 in combination with paclitaxel versus paclitaxel alone as second-line treatment for patients with advanced biliary tract cancer. The primary end point is ORR, and crossover is allowed. Clinical Trial Registration:NCT05506943 (ClinicalTrials.gov).

KW - CTX-009

KW - DLL4

KW - Paclitaxel

KW - VEGF

KW - anti-angiogenesis

KW - biliary tract cancer

KW - cholangiocarcinoma

KW - clinical trial

UR - http://www.scopus.com/inward/record.url?scp=85195367895&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85195367895&partnerID=8YFLogxK

U2 - 10.1080/14796694.2024.2351351

DO - 10.1080/14796694.2024.2351351

M3 - Article

C2 - 38861293

AN - SCOPUS:85195367895

SN - 1479-6694

VL - 20

SP - 2241

EP - 2248

JO - Future Oncology

JF - Future Oncology

IS - 30

ER -

COMPANION-002 A clinical trial of investigational drug CTX-009 plus paclitaxel vs paclitaxel in second line advanced BTC

Abstract

Keywords

ASJC Scopus subject areas

UN SDGs

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