Trials / Active Not Recruiting
Active Not RecruitingNCT05867303
A RC198 Study in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors
A Phase 1, First-in-Human, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Immunogenetic and Efficacy of RC198 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- Sponsor
- RemeGen Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Safety study of RC198 in Subjects with Solid Tumors.
Detailed description
This is a Phase 1, first-in-human, open-label study to determine the safety, tolerability, maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of RC198 in subjects with locally advanced unresectable or metastatic solid tumors for whom standard therapy does not exist, is no longer effective, or is not acceptable.
Conditions
- Melanoma
- Urothelial Carcinoma
- Renal Cell Carcinoma
- Non-small Cell Lung Cancer
- Head and Neck Squamous Cell Carcinoma
- Colorectal Carcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RC198 Injection | RC198 injection will be administered subcutaneously on Day 1 of Week 1 to Week 4 (inclusive) of each 6-week (42-day) cycle. |
Timeline
- Start date
- 2023-06-05
- Primary completion
- 2024-09-30
- Completion
- 2024-12-31
- First posted
- 2023-05-19
- Last updated
- 2024-08-16
Locations
5 sites across 2 countries: Australia, China
Source: ClinicalTrials.gov record NCT05867303. Inclusion in this directory is not an endorsement.