A First-in-Human, Phase 1 Study of JAB-3312 in Adult Patients With Advanced Solid Tumors
NCT04045496 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2025-12-29
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
- DRUG
-
JAB-3312
JAB-3312 will be supplied as 0.25 mg and 1.0 mg capsules.
Sponsors & Collaborators
-
Jacobio Pharmaceuticals Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Jacobio Pharmaceuticals · Jacobio Pharmaceuticals
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-09-26
- Primary Completion
- 2022-12-16
- Completion
- 2022-12-16
- FDA Drug
- Yes
Countries
- United States
Study Locations
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