Actively Recruiting
Phase1/2a Study for IPG7236 in Patients With Advanced Solid Tumors
Led by Nanjing Immunophage Biotech Co., Ltd · Updated on 2025-09-24
196
Participants Needed
7
Research Sites
213 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Phase1/2a Study for IPG7236 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent before any study procedures
- Male or female aged 18 years or older
- Diagnosed with advanced or recurrent solid malignancy that is metastatic or unresectable
- For dose escalation phase: any solid tumor type
- For dose expansion phase: renal cancer, triple-negative breast cancer, head and neck cancer, or melanoma
- Failed or intolerant to standard anti-cancer treatments, or ineligible for such treatments
- Measurable disease by RECIST v1.1 criteria
- Life expectancy of at least 3 months
- ECOG performance status of 0 to 1
- Adequate blood counts and organ function as specified
- Able to swallow and retain oral medication
- Willing and able to comply with study visits, treatment, and tests
- Female patients of child-bearing potential must have a negative pregnancy test
- Female patients of child-bearing potential must use effective contraception during the study
- Male patients with female partners of child-bearing potential must use effective contraception or be sterile
You will not qualify if you...
- Primary central nervous system malignancy or HIV-related malignancies or solid organ transplant
- Not recovered from prior antitumor therapy toxicities above Grade 1 (except alopecia)
- Recent prior therapy: investigational or FDA-approved anticancer drugs within 14 days or 5 half-lives; radiotherapy, chemotherapy, targeted therapy, immunotherapy within 14 days; major surgery within 28 days; certain antibodies or drugs within 42 days before study drug
- Uncontrolled severe diseases or active infections
- Positive COVID-19 PCR test (except recovered patients with positive test at investigator discretion)
- Received live or attenuated vaccine within 4 weeks before study or plans to during study
- Positive hepatitis B surface antigen or hepatitis C antibody without negative RNA PCR; known HIV infection unless well-controlled as specified
- Previous malignancy within last 3 years except certain treated cancers
- Symptomatic or untreated brain or spinal metastases or compression except stable and asymptomatic cases as defined
- Active upper digestive tract ulcers or disorders affecting drug absorption
- Prolonged QTc interval or using medications that prolong QT/QTc
- Pregnant or breastfeeding females; must use effective contraception as required
- Unable to comply with study and follow-up procedures
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Providence Portland Medical Center
Portland, Oregon, United States, 97222
Actively Recruiting
2
NEXT Oncology
Austin, Texas, United States, 12221
Actively Recruiting
3
The First Affiliated Hospital Nanchang Univeristy
Nanchang, Jiangxi, China
Actively Recruiting
4
Shandong Cancer Hospital
Jinan, Shangdong, China
Actively Recruiting
5
Shanghai East Hospital
Shanghai, China
Actively Recruiting
6
Shanghai General Hospital
Shanghai, China
Active, Not Recruiting
7
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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