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NCT04432857 · ClinicalTrials.gov registry record · Phase 1
AN0025 and Pembrolizumab Combination in Advanced Solid Tumors
A Phase 1 study of Cervical Cancer and Triple Negative Breast Cancer, sponsored by Adlai Nortye Biopharma Co..
- Active
- Registry status
- Phase 1
- Development phase
- 63
- Enrollment target
- 6
- Study locations
NCT04432857 is a Phase 1 study of Cervical Cancer and Triple Negative Breast Cancer that is active but no longer recruiting, run by Adlai Nortye Biopharma Co.. The registered enrollment target is 63 participants, below the 570-participant average among 144 other Cervical Cancer trials with a reported enrollment target (89% lower). The trial reports 6 study locations across 5 states.
The verdict
NCT04432857, a Phase 1 study of Cervical Cancer and Triple Negative Breast Cancer, is active but no longer recruiting, sponsored by Adlai Nortye Biopharma Co..
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 63 participants
- Enrollment target
- 6
- Study locations
Study Summary
This is an open-label, multicenter, phase Ib study to evaluate the safety and preliminary efficacy of AN0025 in combination with pembrolizumab in patients with locally advanced/metastatic tumors. It will include a dose-limiting toxicity observation phase followed by an expansion phase. All enrolled patients will be treated with AN0025 and Pembrolizumab until the patient experiences disease progression, unacceptable toxicity or withdraws consent, or for a maximum of 35 cycles (approximately 2 years). The dose of pembrolizumab will remain constant at 200 mg every 3 weeks (Q3W) for each dose level of AN0025 and in each cohort.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG AN0025
Study Locations (6)
Other
- Centre Léon Bérard - Lyon
- Gustave Roussy - Paris
Missouri
- Washington University School of Medicine - Siteman Cancer Center - St Louis
Texas
- MD Anderson Cancer Center - Houston
Utah
- University of Utah School of Medicine Huntsman Cancer Institute - Salt Lake City
Virginia
- University of Virginia - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2020-08-20 |
| Est. Completion | 2025-01-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04432857
The ClinicalTrials.gov registry entry for NCT04432857 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 570-participant average among 144 other Cervical Cancer trials with a reported enrollment target (89% lower). The listed sponsor is Adlai Nortye Biopharma Co., which has 6 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Cervical Cancer appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT04432857 reports 6 study locations spanning 5 distinct geographic areas - top geographies include Other, Missouri, Texas.
Frequently Asked Questions
What is clinical trial NCT04432857 about?
NCT04432857 is a clinical study titled "AN0025 and Pembrolizumab Combination in Advanced Solid Tumors". This is an open-label, multicenter, phase Ib study to evaluate the safety and preliminary efficacy of AN0025 in combination with pembrolizumab in patients with locally advanced/metastatic tumors. It will include a dose-limiting toxicity observation phase followed by an expansion phase. All enrolled ...
What is the current status of trial NCT04432857?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 63 participants. The study started on 2020-08-20. Estimated completion is 2025-01-30.
What conditions does trial NCT04432857 study?
This clinical trial studies the following conditions: Cervical Cancer, Triple Negative Breast Cancer, Urothelial Carcinoma of the Bladder, Microsatellite Stable (MSS) Colorectal Cancer (CRC), NSCLC, Squamous or Non-Squamous.
What interventions are being tested in trial NCT04432857?
The interventions under investigation include: Pembrolizumab (DRUG), AN0025 (DRUG).
Who is sponsoring clinical trial NCT04432857?
This trial is sponsored by Adlai Nortye Biopharma Co., which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04432857 being conducted?
This trial has 6 study locations across Missouri, Texas, Utah, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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