Clinical Trial: NCT03708328
A Dose Escalation and Expansion Study of Lomvastomig, a PD-1/TIM-3 Bispecific Antibody, in Participants With Advanced and/or Metastatic Solid Tumors
Status:
COMPLETEDPhase:
Phase 1| Lead Sponsor: | Hoffmann-La Roche |
| Information Provided By: | Hoffmann-La Roche |
| Last Update Posted: | 2025-08-20 |
Study Overview
Brief 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.
Official Title
Conditions
Intervention / Treatment
- Drug: Lomvastomig
Other Study ID Numbers
- NP40435
- 2018-000982-35
- 2018
Start Date (Actual)
Primary Completion Date (Actual)
Study Completion Date (Actual)
Enrollment (Actual)
Study Type
Phase
| Lead Sponsor: | Hoffmann-La Roche |
| Information Provided By: | Hoffmann-La Roche |
| Last Update Posted: | 2025-08-20 |
Study Overview
Brief 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.
Official Title
Conditions
Intervention / Treatment
- Drug: Lomvastomig
Other Study ID Numbers
- NP40435
- 2018-000982-35
- 2018