Clinical Trial: NCT05753722
A First-in-human Study of PRTH-101 Monotherapy +/- Pembrolizumab in Subjects With Advanced Malignancies
Status:
COMPLETEDPhase:
Phase 1| Lead Sponsor: | Incendia Therapeutics |
| Information Provided By: | Incendia Therapeutics |
| Last Update Posted: | 2026-09-28 |
Study Overview
Brief Summary
The goal of this Open-Label Study is to evaluate the safety and tolerability of PRTH-101 alone or in combination with pembrolizumab in adults with advance or metastatic solid tumors.
Official Title
An Open-Label Phase 1 Dose-Escalation and Expansion Study Investigating the Safety, Pharmacokinetics, Pharmacodynamics, and Activity of PRTH-101 Alone or in Combination With Pembrolizumab in Adults With Advanced or Metastatic Solid Tumors
Conditions
Advanced or Metastatic Solid Tumors, Non Small Cell Lung Cancer, NSCLC
Intervention / Treatment
- Biological: PRTH-101
- Biological: Pembrolizumab
Other Study ID Numbers
- PRTH-101-0001
Start Date (Actual)
2023-03-03
Primary Completion Date (Actual)
2026-09-02
Study Completion Date (Actual)
2026-09-02
Enrollment (Actual)
79
Study Type
Interventional
Phase
Phase 1
| Lead Sponsor: | Incendia Therapeutics |
| Information Provided By: | Incendia Therapeutics |
| Last Update Posted: | 2026-09-28 |
Study Overview
Brief Summary
The goal of this Open-Label Study is to evaluate the safety and tolerability of PRTH-101 alone or in combination with pembrolizumab in adults with advance or metastatic solid tumors.
Official Title
An Open-Label Phase 1 Dose-Escalation and Expansion Study Investigating the Safety, Pharmacokinetics, Pharmacodynamics, and Activity of PRTH-101 Alone or in Combination With Pembrolizumab in Adults With Advanced or Metastatic Solid Tumors
Conditions
Advanced or Metastatic Solid Tumors, Non Small Cell Lung Cancer, NSCLC
Intervention / Treatment
- Biological: PRTH-101
- Biological: Pembrolizumab
Other Study ID Numbers
- PRTH-101-0001
Start Date (Actual)
2023-03-03
Primary Completion Date (Actual)
2026-09-02
Study Completion Date (Actual)
2026-09-02
Enrollment (Actual)
79
Study Type
Interventional
Phase
Phase 1