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NCT05753722 · ClinicalTrials.gov registry record · Phase 1
A First-in-human Study of PRTH-101 Monotherapy +/- Pembrolizumab in Subjects With Advanced Malignancies
A Phase 1 study of Non-Small Cell Lung Cancer and NSCLC, sponsored by Incendia Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 270
- Enrollment target
- 11
- Study locations
NCT05753722: Recruiting Phase 1 study of Non-Small Cell Lung Cancer and NSCLC, sponsored by Incendia Therapeutics.
NCT05753722 is a Phase 1 study of Non-Small Cell Lung Cancer and NSCLC that is actively recruiting participants, run by Incendia Therapeutics. The registered enrollment target is 270 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (59% lower). The trial reports 11 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05753722, a Phase 1 study of Non-Small Cell Lung Cancer and NSCLC, is actively recruiting participants, sponsored by Incendia Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 270 participants
- Enrollment target
- 11
- Study locations
Study 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.
Primary Outcome
To evaluate the safety of PRTH-101 as assessed by Adverse Events (AEs), including Serious Adverse Events (SAEs) and Dose Limiting Toxicities (DLTs)
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- BIOLOGICAL PRTH-101
Study Locations (11)
Texas
- The University of Texas MD Anderson Cancer Center - Houston
- NEXT Houston - Houston
- Next Oncology - Irving
- NEXT Oncology - San Antonio
Arizona
- Honor Health Research Institute - Scottsdale
Connecticut
- Yale Cancer Center - New Haven
Massachusetts
- Mass General Cancer Center - Boston
Oregon
- Providence Cancer Institute Franz Clinic - Portland
Pennsylvania
- University of Pittsburgh Medical Center Hillman Cancer Center - Pittsburgh
Tennessee
- Vanderbilt-Ingram Cancer Center - Nashville
Virginia
- Next Oncology - Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 270 participants |
| Start Date | 2023-03-03 |
| Est. Completion | 2027-09-30 |
| Phase | Phase 1 |
What NCT05753722 shows while recruiting
NCT05753722 is an interventional study that assigns participants to a tested intervention. The registered 270 participants enrollment target is mid-sized for trials with a published cap, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (59% lower).
The record links to 3 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT05753722 lists 11 locations in 8 states (Texas, Arizona, Connecticut).
Frequently Asked Questions
What is clinical trial NCT05753722 about?
NCT05753722 is a clinical study titled "A First-in-human Study of PRTH-101 Monotherapy +/- Pembrolizumab in Subjects With Advanced Malignancies". 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.
What is the current status of trial NCT05753722?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 270 participants. The study started on 2023-03-03. Estimated completion is 2027-09-30.
What conditions does trial NCT05753722 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, NSCLC, Advanced or Metastatic Solid Tumors.
What interventions are being tested in trial NCT05753722?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), PRTH-101 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05753722?
This trial is sponsored by Incendia Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05753722 being conducted?
This trial has 11 study locations across Arizona, Connecticut, Massachusetts, Oregon, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05753722's enrollment target sits among peer trials
270 139th of 454 higher than 315 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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