Trials / Active Not Recruiting
Active Not RecruitingNCT04432857
AN0025 and Pembrolizumab Combination in Advanced Solid Tumors
An Open-Label Multicenter Phase Ib Study of AN0025 in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 63 (actual)
- Sponsor
- Adlai Nortye Biopharma Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
- Triple-negative Breast Cancer
- NSCLC, Squamous or Non-Squamous
- Urothelial Carcinoma of the Bladder
- Microsatellite Stable (MSS) Colorectal Cancer (CRC)
- Cervical Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AN0025 | oral administration |
| DRUG | Pembrolizumab | Infusion |
Timeline
- Start date
- 2020-08-20
- Primary completion
- 2024-05-31
- Completion
- 2025-01-30
- First posted
- 2020-06-16
- Last updated
- 2024-06-27
Locations
6 sites across 2 countries: United States, France
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04432857. Inclusion in this directory is not an endorsement.