A Study to Evaluate Safety, Efficacy, and Pharmacokinetics in Participants With Advanced Solid Tumors
NCT04903873 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 110
Last updated 2024-03-15
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
- DRUG
-
EU101
EU101 will be administered via intravenous infusion.
Sponsors & Collaborators
-
Eutilex
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-05-31
- Primary Completion
- 2025-09-30
- Completion
- 2025-12-31
- FDA Drug
- Yes
Countries
- United States
- South Korea
Study Locations
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