Trials / Completed
CompletedNCT04045496
A First-in-Human, Phase 1 Study of JAB-3312 in Adult Patients With Advanced Solid Tumors
A Phase 1, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-3312 in Adult Patients With Advanced Solid Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Jacobio Pharmaceuticals Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 1, first-in-human, open-label dose-escalation study to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) and assess the DLT of JAB-3312. It is anticipated that approximately 24 subjects will be enrolled in the dose-escalation phase of the study. JAB-3312 will be administered orally once daily (QD) in 21-day treatment cycles.
Conditions
- Non-small Cell Lung Cancer
- Colorectal Cancer
- Pancreatic Ductal Carcinoma
- Esophageal Squamous Cell Carcinoma
- Head and Neck Squamous Cell Carcinoma
- Breast Cancer
- Other Solid Tumors
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | JAB-3312 | JAB-3312 will be supplied as 0.25 mg and 1.0 mg capsules. |
Timeline
- Start date
- 2019-09-26
- Primary completion
- 2022-12-16
- Completion
- 2022-12-16
- First posted
- 2019-08-05
- Last updated
- 2025-12-29
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04045496. Inclusion in this directory is not an endorsement.