drugset / Trial / NCT03449030
A Study of TAK-164 in Participants With Advanced Gastrointestinal (GI) Cancer Expressing Guanylyl Cyclase C (GCC)
Non-randomizedSequentialOpen-labelOther
Summary
The purpose of this study is to evaluate the safety of TAK-164 and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) and schedule.
Timeline
- Start
- 2018-04-23
- Primary completion
- 2020-02-27
- Completion
- 2020-02-27
Outcome
Outcome not reported
Stopped: “Insufficient clinical benefit to participants at the selected recommended phase 2 (RP2D) dose in Part A.”
Publications
- Kim R, Leal AD, Parikh A, Ryan DP, Wang S, Bahamon B, Gupta N, Moss A, Pye J, Miao H, Inguilizian H, Cleary JM. A phase I, first-in-human study of TAK-164, an antibody-drug conjugate, in patients with advanced gastrointestinal cancers expressing guanylyl cyclase C. Cancer Chemother Pharmacol. 2023 Apr;91(4):291-300. doi: 10.1007/s00280-023-04507-w. Epub 2023 Feb 4.
- Abu-Yousif AO, Cvet D, Gallery M, Bannerman BM, Ganno ML, Smith MD, Lai KC, Keating TA, Stringer B, Kamali A, Eng K, Koseoglu S, Zhu A, Xia CQ, Landen MS, Borland M, Robertson R, Bolleddula J, Qian MG, Fretland J, Veiby OP. Preclinical Antitumor Activity and Biodistribution of a Novel Anti-GCC Antibody-Drug Conjugate in Patient-derived Xenografts. Mol Cancer Ther. 2020 Oct;19(10):2079-2088. doi: 10.1158/1535-7163.MCT-19-1102. Epub 2020 Aug 11.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 89Zr-TAK-164 | Diagnostic / imaging agent | — | Intravenous |
| Subject | TAK-164 | Other / unclassified | 0.004 mg/kg | Intravenous |
| Subject | TAK-164 | Other / unclassified | 0.008 mg/kg | Intravenous |
| Subject | TAK-164 | Other / unclassified | 0.032 mg/kg | Intravenous |
| Subject | TAK-164 | Other / unclassified | 0.064 mg/kg | Intravenous |
| Subject | TAK-164 | Other / unclassified | 0.19 mg/kg | Intravenous |
| Subject | TAK-164 | Other / unclassified | 0.25 mg/kg | Intravenous |