Trials / Terminated
TerminatedNCT05012618
A Dose-escalation Study of LUNA18 in Patients With Locally Advanced or Metastatic Solid Tumors (With Expansion).
A Phase 1 Open-label, Dose-escalation and Cohort Expansion Study of LUNA18 Monotherapy and Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 128 (actual)
- Sponsor
- Chugai Pharmaceutical · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 1 dose-escalation and cohort expansion study that will evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary activity of LUNA18 when administered as a single agent or in combination with other anti-cancer drugs in patients with locally advanced or metastatic solid tumors.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LUNA18 | LUNA18 Capsule |
| DRUG | Cetuximab | Cetuximab as a IV infusion |
Timeline
- Start date
- 2021-10-08
- Primary completion
- 2025-11-13
- Completion
- 2025-11-13
- First posted
- 2021-08-19
- Last updated
- 2025-12-24
Locations
20 sites across 2 countries: United States, Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05012618. Inclusion in this directory is not an endorsement.