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AN0025 and Pembrolizumab Combination in Advanced Solid Tumors
NCT04432857 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Adlai Nortye Biopharma Co., which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04432857 reports 6 study locations spanning 5 distinct geographic areas — top geographies include Other, Missouri, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04432857?
The interventions under investigation include: Pembrolizumab (DRUG), AN0025 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04432857?
This trial is sponsored by Adlai Nortye Biopharma Co., which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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