A Study of TAK-676 With Pembrolizumab After Radiation Therapy to Treat a Number of Cancers

Summary

In this study, adults with non-small-cell lung cancer (NSCLC), triple-negative breast cancer (TNBC) and squamous-cell carcinoma of the head and neck (SCCHN) will be treated with TAK-676 and pembrolizumab following radiotherapy. The main aims of this study are to check if people are improving after treatment with TAK-676, getting side effects from these combined treatments, and how much TAK-676 people with these cancers can receive without getting unacceptable side effects from it. Participants will receive radiotherapy, then at least 40 hours later will receive pembrolizumab followed by TAK-676 slowly through a vein (infusion). Participants will receive an infusion of pembrolizumab at the same dose every 3 weeks. Different small groups of participants will receive lower to higher doses of TAK-676 on specific days of a 21-day cycle. This study will be happening at sites in North America.

Timeline

Start

2021-09-09

Primary completion

2024-04-30

Completion

2024-04-30

Publications

• Saravanakumar A, Deng R, Dong L, Haridas S, Xia CQ, Appleman VA, Abu-Yousif AO, Piatkov K, Wang H. Population-Based Modeling to Predict Human PK/PD of TAK-500, an Anti-CCR2 Antibody-Drug Conjugate for First-in-Human Study in Cancer Patients. Clin Transl Sci. 2026 Apr;19(4):e70522. doi: 10.1111/cts.70522.
• Cooper BT, Iams WT, Page DB, Yuan Y, Gerber NK, Luke JJ, Gibbs JP, Gregory RC, Wong KK, Deng J, Perera SA, Ding K, Roberts ER, Berger A, Christensen CL, Tong EX, Maldonado Lopez AE, Appleman VA, Leonard EJ, Parent A, Huang YC, Bay C, Li C, Lineberry N, Raizer J, Olson DJ, Chmura SJ. Phase 1b Study of Dazostinag plus Pembrolizumab after Hypofractionated Radiotherapy in Patients with Select Advanced Solid Tumors. Cancer Res Commun. 2025 Dec 1;5(12):2249-2263. doi: 10.1158/2767-9764.CRC-25-0566.
• Carideo Cunniff E, Sato Y, Mai D, Appleman VA, Iwasaki S, Kolev V, Matsuda A, Shi J, Mochizuki M, Yoshikawa M, Huang J, Shen L, Haridas S, Shinde V, Gemski C, Roberts ER, Ghasemi O, Bazzazi H, Menon S, Traore T, Shi P, Thelen TD, Conlon J, Abu-Yousif AO, Arendt C, Shaw MH, Okaniwa M. TAK-676: A Novel Stimulator of Interferon Genes (STING) Agonist Promoting Durable IFN-dependent Antitumor Immunity in Preclinical Studies. Cancer Res Commun. 2022 Jun 23;2(6):489-502. doi: 10.1158/2767-9764.CRC-21-0161. eCollection 2022 Jun.

Drugs

Indications