A Dose Escalation and Expansion Study of Lomvastomig, a PD-1/TIM-3 Bispecific Antibody, in Participants With Advanced and/or Metastatic Solid Tumors

Summary

This is a first-in-human, open-label, multicenter, Phase I multiple-ascending dose (MAD) study of single agent lomvastomig (RO7121661), an anti PD-1 (programmed death-1) and TIM-3 (T-cell immunoglobulin and mucin domain 3) bispecific antibody, for participants with advanced and/or metastatic solid tumors. The study consists of 2 parts: Dose Escalation (Part A) and Expansion (Parts B1, B2, B3, B4, and B5). The Dose Escalation part will be conducted first to determine the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) based on safety, tolerability, pharmacokinetic, and/or the pharmacodynamic profile of escalating doses of lomvastomig. The Expansion part will enroll tumor-specific cohorts to evaluate anti-tumor activity of the MTD and/or RDE of lomvastomig from Part A (Q2W) and to confirm safety and tolerability in participants with selected tumor types.

Timeline

Start

2018-10-15

Primary completion

2024-07-09

Completion

2024-07-09

Publications

• Rohrberg KS, Melero I, F Sanmamed M, Munoz-Couselo E, Cervantes A, Gambardella V, Greillier L, Garrido P, Kim HR, Lee DH, Italiano A, Cassier PA, Hiret S, Deva S, Kim TM, Blumenschein GR Jr, Lovendahl Eefsen R, Henick BS, Perro M, Umana P, Peixoto A, Lauener L, Weber P, Seeber S, Klein C, Higgins B, Guidi M, Kraus D, Mucke M, Heichinger C, Tran VL, Schmid D, Michielin F, Liu T, McIntyre C, Kao H, Codarri Deak L, Markert C, Moreno V. First-in-human study of lomvastomig, a PD-1-TIM-3 bispecific antibody, in patients with advanced and/or metastatic solid tumors. J Immunother Cancer. 2026 Jun 19;14(6):e012729. doi: 10.1136/jitc-2025-012729.

Drugs

Indications