Phase1/2a Study for IPG7236 in Patients With Advanced Solid Tumors
NCT05142592 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 196
Last updated 2025-09-24
Summary
This is a Phase 1/2a first-in-human, multi-center, non-randomized, open-label study to assess the safety, tolerability, pharmacokinetics profile, and preliminary anti-tumor activity of IPG7236 administered orally as a single agent to patients with advanced solid tumors.
The study will include a dose escalation phase (Phase 1) and a dose expansion phase (Phase 2a).
Each part will consist of a screening period of up to 28 days, a treatment period, an end of treatment visit and a safety follow-up of approximately 30 days after the last dose. IPG7236 will be given on an empty stomach (either one hour before or two hours after a meal) twice daily (approximately every 12±1 hours) in continuous 28-day cycles.
Conditions
- Safety Issues
- Tolerability
- Pharmacokinetics
Interventions
- DRUG
-
IPG7236
The IPG7236 drug product is supplied as oral tablet dosage form, containing two strengths: 25 mg and 100 mg, respectively, which contain IPG7236.
Sponsors & Collaborators
-
Nanjing Immunophage Biotech Co., Ltd
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-11-15
- Primary Completion
- 2025-09-21
- Completion
- 2025-12-21
- FDA Drug
- Yes
Countries
- United States
- China
Study Locations
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