NCT02000934

A Study of TAK-659 in Adult Participants With Advanced Solid Tumor and Lymphoma Malignancies

Completed Phase 1 Last updated 8 February 2023

What this trial tests

Phase 1 trial testing TAK-659 in Advanced Solid Tumor and Lymphoma Malignancies in 143 participants. Completed in 29 June 2021.

Timeline

31 December 2013

Primary endpoint
29 June 2021

29 June 2021

Quick facts

Lead sponsor	Calithera Biosciences, Inc
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	143
Start date	31 December 2013
Primary completion	29 June 2021
Estimated completion	29 June 2021
Sites	15 locations across Italy, United Kingdom, United States, Spain

Drugs / interventions tested

• TAK-659 — full drug profile →

Conditions studied

• Advanced Solid Tumor and Lymphoma Malignancies — all drugs for Advanced Solid Tumor and Lymphoma Malignancies →

Sponsor

Calithera Biosciences, Inc — full company profile →

Who can join

18 and older, any sex, with Advanced Solid Tumor and Lymphoma Malignancies. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is an open-label, multicenter, phase 1, dose escalation study of TAK-659 in adult participants with advanced solid tumor and lymphoma malignancies. This study will be the first to administer TAK-659 to humans. The participants population during dose escalation (Part A) will consist of adults previously diagnosed with any form of a solid tumor or lymphoma for which standard, curative, or life-prolonging treatment does not exist or is no longer effective. This first-in-human (FIH) study will include 5 dose expansion cohorts in refractory and/or relapsed Chronic Lymphocytic Leukemia (CLL), Diffuse Large B Cell Lymphoma (DLBCL), indolent Non Hodgkin Lymphoma (iNHL), Mantle Cell Lymphoma (MCL), Post Transplant Lymphoproliferative Disorder (PTLD) (Part B) following completion of dose escalation (Part A).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Syk inhibitors in clinical development for hematological malignancies.
   Liu D, Mamorska-Dyga A. · · 2017 · cited 130× · PMID 28754125 · DOI 10.1186/s13045-017-0512-1
2. From Biology to Therapy: The CLL Success Story.
   Yosifov DY, Wolf C, Stilgenbauer S, Mertens D. · · 2019 · cited 48× · PMID 31723816 · DOI 10.1097/hs9.0000000000000175
3. Dysregulation of Cell Survival in Diffuse Large B Cell Lymphoma: Mechanisms and Therapeutic Targets.
   Miao Y, Medeiros LJ, Xu-Monette ZY, Li J, et al · · 2019 · cited 39× · PMID 30881917 · DOI 10.3389/fonc.2019.00107
4. Spleen Tyrosine Kinase Inhibitor TAK-659 Prevents Splenomegaly and Tumor Development in a Murine Model of Epstein-Barr Virus-Associated Lymphoma.
   Cen O, Kannan K, Huck Sappal J, Yu J, et al · · 2018 · cited 14× · PMID 30135222 · DOI 10.1128/mspheredirect.00378-18
5. New insights into SYK targeting in solid tumors.
   Joshi S. · · 2024 · cited 8× · PMID 39322438 · DOI 10.1016/j.tips.2024.08.006
6. Efficacy and safety of FLT3 inhibitors in monotherapy of hematological and solid malignancies: a systemic analysis of clinical trials.
   Zhao Y, Zhang X, Ding X, Wang Y, et al · · 2024 · cited 7× · PMID 38828446 · DOI 10.3389/fphar.2024.1294668
7. Challenges in nodal peripheral T-cell lymphomas: from biological advances to clinical applicability.
   Zain J, Kallam A. · · 2023 · cited 7× · PMID 37188189 · DOI 10.3389/fonc.2023.1150715
8. Spleen tyrosine kinase/FMS-like tyrosine kinase-3 inhibition in relapsed/refractory B-cell lymphoma, including diffuse large B-cell lymphoma: updated data with mivavotinib (TAK-659/CB-659).
   Gordon LI, Karmali R, Kaplan JB, Popat R, et al · · 2023 · cited 5× · PMID 36702329 · DOI 10.18632/oncotarget.28352