Trials / Completed
CompletedNCT03708328
A Dose Escalation and Expansion Study of Lomvastomig, a PD-1/TIM-3 Bispecific Antibody, in Participants With Advanced and/or Metastatic Solid Tumors
An Open Label, Multicenter, Dose Escalation and Expansion, Phase 1 Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-Tumor Activity of RO7121661, a PD-1/TIM-3 Bispecific Antibody, in Patients With Advanced and/or Metastatic Solid Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 134 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Solid Tumors
- Metastatic Melanoma
- Non-small Cell Lung Cancer (NSCLC)
- Small Cell Lung Cancer (SCLC)
- Esophageal Squamous Cell Carcinoma (ESCC)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lomvastomig | Lomvastomig will be administered intravenously (IV) with a flat dose on the schedule described for each study arm. |
Timeline
- Start date
- 2018-10-15
- Primary completion
- 2024-07-09
- Completion
- 2024-07-09
- First posted
- 2018-10-17
- Last updated
- 2025-08-20
- Results posted
- 2025-08-20
Locations
17 sites across 6 countries: United States, Denmark, France, New Zealand, South Korea, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03708328. Inclusion in this directory is not an endorsement.