A Study of Modakafusp Alfa (TAK-573) Given by Itself and Together With Pembrolizumab in Adults With Advanced or Metastatic Solid Tumors

Summary

This study has 2 phases. The main aims of Phase 1b are: * to check for side effects from modakafusp alfa in adults with locally advanced or metastatic solid tumors. * to learn how much modakafusp alfa adults can receive without getting any major side effects from it. The main aims of Phase 2 are: * to check for side effects from modakafusp alfa when given together with pembrolizumab in adults with metastatic cutaneous melanoma which cannot be completely removed by surgery. * to learn how these medicines improve their symptoms. Participants will receive modakafusp alfa for up to 1 year (Phase 1b) or modakafusp alfa given together with pembrolizumab for up to 2 years (Phase 2). Those whose symptoms improve might continue treatment for longer. In both phases of the study, participants will revisit the study clinic within 30 days after their last dose or before they start other cancer treatment, whichever happens first.

Timeline

Start

2019-12-12

Primary completion

2023-12-20

Completion

2023-12-20

Publications

• Gill D, Cowey CL, Daniels GA, Sommerhalder D, Abdul-Karim R, Kirkwood JM, Kolodney J, Mehmi I, Roberts-Thomson R, Strauss J, Thomas S, Whitman E, Xing Y, McKean M, Collins S, Li C, Saggu G, Chen T, Wang S, Lewis M, Parot X, Johnson M. A phase Ib/II study of modakafusp alfa alone and in combination with pembrolizumab in patients with advanced or metastatic solid tumors. Front Oncol. 2025 Dec 8;15:1620987. doi: 10.3389/fonc.2025.1620987. eCollection 2025.

Drugs

Indications