Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05215574 · ClinicalTrials.gov registry record · Phase 1
Study of NGM831 as Monotherapy and in Combination With Pembrolizumab or Pembrolizumab and NGM438 in Advanced or Metastatic Solid Tumors
A Phase 1 study of Breast Cancer and Non-Small Cell Lung Cancer, sponsored by NGM Biopharmaceuticals.
- Active
- Registry status
- Phase 1
- Development phase
- 130
- Enrollment target
- 9
- Study locations
NCT05215574: Active Phase 1 study of Breast Cancer and Non-Small Cell Lung Cancer, sponsored by NGM Biopharmaceuticals.
NCT05215574 is a Phase 1 study of Breast Cancer and Non-Small Cell Lung Cancer that is active but no longer recruiting, run by NGM Biopharmaceuticals. The registered enrollment target is 130 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (95% lower). The trial reports 9 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05215574, a Phase 1 study of Breast Cancer and Non-Small Cell Lung Cancer, is active but no longer recruiting, sponsored by NGM Biopharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 130 participants
- Enrollment target
- 9
- Study locations
Study Summary
Study of NGM831 as Monotherapy and in Combination with Pembrolizumab or Pembrolizumab and NGM438 in Advanced or Metastatic Solid Tumors
Primary Outcome
A DLT is defined as an AE that meets at least one of the criteria listed in protocol, according to National Cancer Institute (NCI) common terminology criteria for AE (CTCAE) version 5.0 and is considered by the Investigator to be clinically relevant and attributed to the study treatment during the first 21 days after the first dose of study treatment.
Conditions Studied
Interventions
- DRUG NGM831
- DRUG NGM831 plus pembrolizumab (KEYTRUDA®)
- DRUG NGM831 and NGM438 plus pembrolizumab (KEYTRUDA®)
Study Locations (9)
Florida
- NGM Clinical Study Site - Sarasota
- NGM Clinical Study Site - Tampa
Texas
- NGM Clinical Study Site - Austin
- NGM Clinical Study Site - Houston
Arizona
- NGM Clinical Study Site - Gilbert
California
- NGM Clinical Study Site - Los Angeles
Michigan
- NGM Clinical Study Site - Grand Rapids
New York
- NGM Clinical Study Site - New York
Oklahoma
- NGM Clinical Study Site - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2022-03-31 |
| Est. Completion | 2026-03 |
| Phase | Phase 1 |
What the registry record for NCT05215574 still lists
NCT05215574 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (95% lower).
The record links to 10 conditions, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which NGM831 is the first listed.
NCT05215574 lists 9 locations in 7 states (Florida, Texas, Arizona).
Frequently Asked Questions
What is clinical trial NCT05215574 about?
NCT05215574 is a clinical study titled "Study of NGM831 as Monotherapy and in Combination With Pembrolizumab or Pembrolizumab and NGM438 in Advanced or Metastatic Solid Tumors". Study of NGM831 as Monotherapy and in Combination with Pembrolizumab or Pembrolizumab and NGM438 in Advanced or Metastatic Solid Tumors
What is the current status of trial NCT05215574?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 130 participants. The study started on 2022-03-31. Estimated completion is 2026-03.
What conditions does trial NCT05215574 study?
This clinical trial studies the following conditions: Breast Cancer, Non-Small Cell Lung Cancer, Pancreatic Cancer, Gastric Cancer, Cervical Cancer.
What interventions are being tested in trial NCT05215574?
The interventions under investigation include: NGM831 (DRUG), NGM831 plus pembrolizumab (KEYTRUDA®) (DRUG), NGM831 and NGM438 plus pembrolizumab (KEYTRUDA®) (DRUG).
Who is sponsoring clinical trial NCT05215574?
This trial is sponsored by NGM Biopharmaceuticals, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05215574 being conducted?
This trial has 9 study locations across Arizona, California, Florida, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05215574's enrollment target sits among peer trials
130 489th of 1224 higher than 730 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
VS-6766+Abema+Fulv in Met HR+/HER- BC
RECRUITING · Phase 1
-
KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer
RECRUITING · Phase 1
-
Focused Ultrasound and Gemcitabine in Breast Cancer
RECRUITING · Phase 1
-
A Phase I/IIa Study of AZD8205 Given Alone or Combined, in Participants With Advanced/Metastatic Solid Malignancies
RECRUITING · Phase 1
-
Study of Orally Administered MOMA-313 in Participants With Advanced or Metastatic Solid Tumors
RECRUITING · Phase 1
-
A Study of MT-4561 in Patients With Various Advanced Solid Tumors
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01492036 · 130 participants
Long-Term Follow-Up of Recipient of Gene Transfer Research
- NCT01631617 · 130 participants · Phase 2
Effects of Treatments on Atopic Dermatitis
- NCT02368041 · 130 participants
Utility of Thenar Near Infrared Spectroscopy (NIRS) in Pediatric Patients With Heart Failure
- NCT02604277 · 130 participants · NA
Suicidal Behavior in Patients Diagnosed With Bipolar Disorder
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI