Trials / Completed
CompletedNCT03881488
Study of CTX-471 as a Monotherapy or in Combination With Pembrolizumab in Patients Post PD-1/PD-L1 Inhibitors in Metastatic or Locally Advanced Malignancies
A Phase 1, Open-Label, Multiple-Ascending Dose Study of the Safety and Tolerability of CTX-471 Administered Either as a Monotherapy or in Combination With Pembrolizumab in Patients With Inadequate Responses to PD-1/PD-L1 Checkpoint Inhibitors in Metastatic or Locally Advanced Malignancies
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- Compass Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 1, open-label, first-in-human study of CTX-471 administered as a monotherapy or in combination with pembrolizumab in patients with metastatic or locally advanced malignancies that have progressed while receiving an approved PD-1 or PD-L1 inhibitor. The study will be conducted in 2 treatment arms (Monotherapy Arm 1 and Combination Arm 2). Each arm will have two parts: Part 1 Dose Escalation and Part 2 Dose Expansion.
Conditions
- Locally Advanced Solid Tumor
- Metastatic Cancer
- Non-small Cell Lung Cancer
- Small Cell Lung Cancer
- Mesothelioma
- Melanoma
- Head and Neck Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CTX-471 | IV infusion every 2 weeks |
| DRUG | Pembrolizumab (KEYTRUDA®) | IV infusion every 6 weeks |
Timeline
- Start date
- 2019-05-17
- Primary completion
- 2025-05-21
- Completion
- 2025-05-21
- First posted
- 2019-03-19
- Last updated
- 2026-04-17
Locations
10 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03881488. Inclusion in this directory is not an endorsement.