Actively Recruiting
Phase I/II Study of IPG1094 in Advanced Solid Tumors Patients
Led by Nanjing Immunophage Biotech Co., Ltd · Updated on 2025-09-24
60
Participants Needed
2
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase 1, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) characteristics and initial anti-tumor activity of IPG1094 in patients with advanced solid tumors. The study will be conducted in two parts: dose escalation phase (Part A) and expansion phase (Part B).
CONDITIONS
Official Title
Phase I/II Study of IPG1094 in Advanced Solid Tumors Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Histological diagnosis of locally advanced or metastatic malignant solid tumors not suitable for curative surgical or locoregional therapies
- Failed or intolerant to standard therapies, or standard therapies not effective or unsuitable
- At least one measurable lesion according to RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
- Life expectancy of at least 12 weeks
- Adequate organ and bone marrow function with specific lab values within defined limits
- Women of childbearing potential and fertile males with such partners must use effective contraception during the study and for 28 days after
- Signed informed consent approved by Institutional Review Board or Ethics Committee
You will not qualify if you...
- Received anti-tumor therapy (except certain drugs) within 4 weeks before first dose
- Previous anti-tumor therapy toxicity not recovered to grade 0 or 1 (except specified conditions)
- Use of CYP3A4 strong inhibitors or inducers within 14 days before first dose or required use during study
- Recent biliary obstruction intervention or unresolved symptoms
- Clinically uncontrolled pleural effusion, ascites, or pericardial effusion within 2 weeks before first dose
- Symptomatic brain metastases or spinal cord compression; stable treated brain metastases allowed
- Active bacterial or fungal infections requiring treatment within 14 days before first dose
- Participation in other investigational drug or device studies within 28 days or 5 half-lives
- Systemic steroid therapy over 10 mg/day prednisone or equivalent within 7 days before first dose
- Chronic or active infections requiring systemic therapy
- Gastrointestinal disorders affecting oral drug absorption
- Known or suspected allergy to IPG1094 components
- HIV positive or diagnosed at screening
- Positive Hepatitis B surface antigen test except certain antibody and DNA negative cases
- Co-infection with hepatitis B and C viruses or active hepatitis C infection
- Active other malignancies requiring treatment except specified low-risk or treated cancers
- Significant cardiovascular disease within 6 months prior to enrollment
- Receiving warfarin (except low dose) or specified antiplatelet therapy
- Major surgery or significant trauma within 28 days before first dose without full recovery
- Pregnancy or lactation
- Difficulty in venous blood collection or other conditions affecting consent, adherence, safety, or study outcome
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Shanghai General Hospital
Shanghai, Shanghai Municipality, China, 200080
Actively Recruiting
2
Shanghai GoBroad Cancer Hospital China Pharmaceutical University
Shanghai, China
Actively Recruiting
Research Team
F
Filipe Huang
CONTACT
Y
Yang Hu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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