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NCT05538130 · ClinicalTrials.gov registry record · Phase 1
A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors
A Phase 1 study of Non-Small Cell Lung Cancer and Melanoma, sponsored by Pfizer.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 124
- Enrollment target
- 20
- Study locations
NCT05538130: Recruiting Phase 1 study of Non-Small Cell Lung Cancer and Melanoma, sponsored by Pfizer.
NCT05538130 is a Phase 1 study of Non-Small Cell Lung Cancer and Melanoma that is actively recruiting participants, run by Pfizer. The registered enrollment target is 124 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (81% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05538130, a Phase 1 study of Non-Small Cell Lung Cancer and Melanoma, is actively recruiting participants, sponsored by Pfizer.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 124 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this clinical trial is to learn the safety and effects of the study medicine (PF-07799544) alone or in combination as a potential cancer treatment for adults with advanced solid tumors. The study will be conducted in two parts: PF-07799544 as a single agent (Phase 1a) and PF-07799544 in combination with another study medicine called PF-07799933 (Phase 1b). Phase 1a is no longer open for enrollment. In Phase1b (noted as "this study"), we are seeking participants who have: * a solid tumor which is metastatic or recurrent (excluding colorectal cancer) * tumor with the mutation (abnormal gene) called "BRAF V600" * received required prior treatment for cancer per cohort assigned. All participants in this study will receive both study medicines. Both study medicines are tablets that are taken by mouth at home twice a day. Participants will receive study medicines until their cancer is no longer responding, unacceptable side effects, or 2 years. Participants may continue to receive study therapy beyond 2 years. We will examine the experiences of people receiving the study medicines. This will help us determine if the study medicines are safe and effective.
Primary Outcome
DLTs will be evaluated during the first cycle (21 days) as a single agent (phase 1a monotherapy) or in combination with other agents (phase 1b dose escalation)
Conditions Studied
Interventions
- DRUG PF-07799544
- DRUG PF-07799933
Study Locations (20)
California
- The Angeles Clinic and Research Institute- A Cedars-Sinai Affiliate - Los Angeles
- Keck Hospital of USC - Los Angeles
- Los Angeles General Medical Center - Los Angeles
- USC/Norris Comprehensive Cancer Center - Los Angeles
- Keck Medical Center of USC Pasadena - Pasadena
- UCSF Helen Diller Medical Center at Parnassus Heights - San Francisco
- UCSF Medical Center, Investigational Pharmacy - San Francisco
- The Angeles Clinic and Research Institue, A Cedars-Sinai Affiliate (Emergency Back-up only) - Santa Monica
Alabama
- The Kirklin Clinic of UAB Hospital - Birmingham
- The University of Alabama at Birmingham - Birmingham
- University of Alabama at Birmingham - Phase I Clinical Trials Unit - Birmingham
Arkansas
- Highlands Oncology Group, PA - Fayetteville
- Highlands Oncology Group, PA - Rogers
- Highlands Oncology Group, PA - Springdale
Florida
- Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center - Tampa
- Moffitt Cancer Center - Tampa
- Moffitt McKinley Hospital - Tampa
Massachusetts
- Brigham and Women's Hospital - Boston
- Dana Farber Cancer Institute - Boston
Louisiana
- Ochsner Clinic Foundation - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2022-11-30 |
| Est. Completion | 2028-10-07 |
| Phase | Phase 1 |
What NCT05538130 shows while recruiting
NCT05538130 is an interventional study that assigns participants to a tested intervention. The registered 124 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 (81% lower).
The record links to 10 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which PF-07799544 is the first listed.
NCT05538130 names 20 study sites across 6 states, led by California, Alabama, Arkansas.
Frequently Asked Questions
What is clinical trial NCT05538130 about?
NCT05538130 is a clinical study titled "A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors". The purpose of this clinical trial is to learn the safety and effects of the study medicine (PF-07799544) alone or in combination as a potential cancer treatment for adults with advanced solid tumors. The study will be conducted in two parts: PF-07799544 as a single agent (Phase 1a) and PF-07799544 ...
What is the current status of trial NCT05538130?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 124 participants. The study started on 2022-11-30. Estimated completion is 2028-10-07.
What conditions does trial NCT05538130 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Melanoma, Glioma, Thyroid Cancer, Low Grade Glioma.
What interventions are being tested in trial NCT05538130?
The interventions under investigation include: PF-07799544 (DRUG), PF-07799933 (DRUG).
Who is sponsoring clinical trial NCT05538130?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05538130 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Florida, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05538130's enrollment target sits among peer trials
124 217th of 454 higher than 238 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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