Clinical Study Protocol AN4005X0101 An Open-Label, Multicenter, Phase 1 Study of AN4005 in Patients With Advanced Tumors
Adlai Nortye Biopharma Co., Ltd.
Summary
Open-label, multicenter, phase 1 study to investigate the safety, tolerability, and PK of AN4005 in patients with advanced tumors. This study is a first-in-human, dose escalation study with the objective to establish the MTD and/or RP2D of AN4005. Except for Dose Level 0 (50 mg), a traditional "3 + 3 design" will be utilized for dose finding with dose escalation and/or de-escalation as appropriate.
Description
In this study, one sentinel patient will be dosed at 50 mg first, then increasing doses of AN4005 will be administered to cohorts of 3 subjects, at doses ranging from 100 mg twice daily (BID) to 600 mg BID (see the table below). The proposed starting dose, 50 mg BID, has been selected based on integrated data from nonclinical studies. If 50 mg BID for one cycle is deemed to be tolerable upon review of safety data, the dose of AN4005 will be escalated to 100 mg BID in a cohort of 3 patients, and further dose escalations will be performed in separate cohorts based on review of data from all prec…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 1\. Age ≥ 18 years at the time of informed consent and have provided signed informed consent for the trial. 2\. Willing and able to comply with all aspects of the protocol. 3\. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 4\. Life expectancy ≥ 3 months. 5\. Subjects with histologically or cytologically confirmed advanced solid tumors that are metastatic or unresectable, or relapsed or refractory (r/r) lymphoma, and for whom standard life-prolonging measures are not available. Types of lymphoma may include, but are not limited to, na…
Interventions
- DrugAN4005-dose level 0
50mg BID
- DrugAN4005-dose level 1
100mg BID
- DrugAN4005-dose level 2
200mg BID
- DrugAN4005-dose level 3
400mg BID
- DrugAN4005-dose level 4
600mg BID
- DrugAN4005-food effect
Dose to be determined upon the MTD determination
Locations (7)
- Hackensack University Medical CenterHackensack, New Jersey
- Montefiore Einstein Cancer CenterThe Bronx, New York
- Prisma Health Institute for Translational Oncology ResearchGreenville, South Carolina
- Next VirginiaFairfax, Virginia
- Beijing Cancer HospitalBeijing, Beijing Municipality
- Harbin Medical University Cancer HospitalHarbin, Heilongjiang