Trials / Unknown
UnknownNCT04903873
A Study to Evaluate Safety, Efficacy, and Pharmacokinetics in Participants With Advanced Solid Tumors
An Open-Label, Phase 1/2 Study to Evaluate Safety, Efficacy, and Pharmacokinetics of EU101, an Agonistic Anti-CD137 (4-1BB) Monoclonal Antibody in Patients With Advanced Solid Tumors
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- Sponsor
- Eutilex · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Phase 1 (Dose Escalation) of this study will assess the safety, tolerability, dose-limiting toxicity (DLT), and will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of EU101 in participants with advanced solid tumors. Phase 2 (Dose Expansion) of the study will assess the antitumor effect of EU101 in two indications including colorectal cancer (CRC) and non-small cell lung cancer (NSCLC).
Conditions
- Solid Tumor
- Renal Cell Cancer Metastatic
- Non-Small Cell Lung Cancer
- Renal Cell Carcinoma
- Prostate Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | EU101 | EU101 will be administered via intravenous infusion. |
Timeline
- Start date
- 2021-05-31
- Primary completion
- 2025-09-01
- Completion
- 2025-12-01
- First posted
- 2021-05-27
- Last updated
- 2024-03-15
Locations
6 sites across 2 countries: United States, South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04903873. Inclusion in this directory is not an endorsement.