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NCT03708328 · ClinicalTrials.gov registry record · Phase 1
A Dose Escalation and Expansion Study of Lomvastomig, a PD-1/TIM-3 Bispecific Antibody, in Participants With Advanced and/or Metastatic Solid Tumors
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 134
- Enrollment target
NCT03708328: Completed Phase 1 study, sponsored by Hoffmann-La Roche.
NCT03708328 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 134 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (123% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03708328, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 134 participants
- Enrollment target
Study 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.
Primary Outcome
A DLT was defined as a clinically significant adverse event (AE) or significant laboratory abnormality: 1) occurring during DLT assessment period of 21 days; 2) considered to be related to study treatment RO7121661 by the Investigator; 3) is not attributed to disease progression or another clearly identifiable cause. Following AEs were considered DLTs: Hematological toxicities (Grade 4 neutropenia lasting \>5 days, Grade ≥3 febrile neutropenia, Grade 4 thrombocytopenia lasting \> 48 hours, Grade
Interventions
- DRUG Lomvastomig
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 134 participants |
| Start Date | 2018-10-15 |
| Est. Completion | 2024-07-09 |
| Phase | Phase 1 |
What the finished NCT03708328 record still lists
NCT03708328 is an interventional study that assigns participants to a tested intervention. The registered 134 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (123% higher).
The record links to 0 conditions, and to 1 intervention - of which Lomvastomig is the first listed.
NCT03708328 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03708328 about?
NCT03708328 is a clinical study titled "A Dose Escalation and Expansion Study of Lomvastomig, a PD-1/TIM-3 Bispecific Antibody, in Participants With Advanced and/or Metastatic Solid Tumors". 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 t...
What is the current status of trial NCT03708328?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 134 participants. The study started on 2018-10-15. Estimated completion is 2024-07-09.
What interventions are being tested in trial NCT03708328?
The interventions under investigation include: Lomvastomig (DRUG).
Who is sponsoring clinical trial NCT03708328?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03708328's enrollment target sits among peer trials
134 427th of 2000 higher than 1,569 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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