Trials / Recruiting
RecruitingNCT06990880
A Study of GSK5458514 Administered Alone or In Combination With Other Anti-Cancer Agents in Participants With Prostate Cancer
A Phase 1/2 First-Time-In-Human, Open-Label, Multicenter, Dose Escalation and Expansion Study of GSK5458514 PSMA Targeting T Cell Engager Alone or in Combination With Other Anti-Cancer Agents in Adult Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 85 (estimated)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The goal of the study is to evaluate how safe and how well the body handles GSK5458514 when administered in participants with prostate cancer. The study will be conducted in two parts - Part 1 (dose escalation phase) and Part 2 (dose expansion phase).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GSK5458514 | GSK5458514 will be administered. |
Timeline
- Start date
- 2025-06-12
- Primary completion
- 2027-10-26
- Completion
- 2028-08-09
- First posted
- 2025-05-25
- Last updated
- 2025-09-08
Locations
5 sites across 3 countries: United States, Canada, Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06990880. Inclusion in this directory is not an endorsement.