Trials / Recruiting
RecruitingNCT06484985
Study of AXT-1003 in Subjects With Advanced Malignant Tumors.
An Open-label, Multicenter, Phase I Safety Study of AXT-1003 in Subjects With Advanced Malignant Tumors
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 78 (estimated)
- Sponsor
- Axter Therapeutics (Beijing) Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase I study of AXT-1003 to assess the safety, tolerability, and pharmacokinetics in patients with advanced malignancies.
Detailed description
AXT1003-1102 is a multicenter, open-label, Phase I safety study of AXT-1003 in patients with advanced malignancies. It is designed to observe the safety of AXT-1003 in patients with advanced malignancies, determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), evaluate the pharmacokinetic profile, and explore the preliminary antitumor activity.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AXT-1003 | AXT-1003 capsule is administered orally daily, until disease progression or intolerable toxicity. |
Timeline
- Start date
- 2024-09-04
- Primary completion
- 2027-03-01
- Completion
- 2027-09-01
- First posted
- 2024-07-03
- Last updated
- 2026-01-28
Locations
5 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06484985. Inclusion in this directory is not an endorsement.