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IPG7236 for Advanced Cancer
Phase 1
Recruiting
Research Sponsored by Nanjing Immunophage Biotech Co., Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of advanced or recurrent, histologically or cytologically confirmed, a solid malignancy that is either metastatic or unresectable
Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year(anticipated)
Awards & highlights
Study Summary
This trial is testing a new drug, IPG7236, to see if it is safe and effective in treating patients with advanced solid tumors. The trial will have two parts, with the first part testing different doses of the drug to see what is safe and tolerable, and the second part expanding to include more patients to further test the drug's effectiveness.
Who is the study for?
Adults with advanced solid tumors that are metastatic or unresectable, who have not responded to standard treatments or cannot tolerate them. They must be able to take oral medication and commit to the study's schedule. Women of childbearing potential and men with partners of childbearing potential must use effective contraception.Check my eligibility
What is being tested?
The trial is testing IPG7236, an oral drug for advanced solid tumors. It includes two phases: dose escalation to find a safe dosage and dose expansion to further assess safety and effectiveness. Patients will take the drug twice daily on an empty stomach in continuous 28-day cycles.See study design
What are the potential side effects?
While specific side effects for IPG7236 aren't listed, common ones for cancer drugs include nausea, fatigue, diarrhea, risk of infection due to low blood counts, liver issues (elevated enzymes), kidney function changes, and possible allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is advanced or has come back, cannot be surgically removed, and has spread.
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I can carry out all my usual activities without help.
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My blood and organ tests meet the required health standards.
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I can swallow and keep down pills.
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I am a woman who can have children and my pregnancy test is negative.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year(anticipated)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year(anticipated)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease Control Rate(DCR)
Maximum tolerated dose (MTD）
Occurrence of all adverse events
+1 moreSecondary outcome measures
Apparent terminal phase half-life (t1/2)
Area under the serum concentration-infinity curve AUC[0-infinity]
Area under the serum concentration-time curve (AUC[0-t]
+6 moreTrial Design
6Treatment groups
Experimental Treatment
Group I: Cohort 6Experimental Treatment1 Intervention
3~6 subjects in this cohort will receive IPG7236 300 mg bid orally.
Group II: Cohort 5Experimental Treatment1 Intervention
3~6 subjects in this cohort will receive IPG7236 250 mg bid orally.
Group III: Cohort 4Experimental Treatment1 Intervention
3~6 subjects in this cohort will receive IPG7236 200 mg bid orally.
Group IV: Cohort 3Experimental Treatment1 Intervention
3~6 subjects in this cohort will receive IPG7236 150 mg bid orally.
Group V: Cohort 2Experimental Treatment1 Intervention
3~6 subjects in this cohort will receive IPG7236 100 mg bid orally.
Group VI: Cohort 1Experimental Treatment1 Intervention
1~6 subjects in this cohort will receive IPG7236 50 mg bid orally.
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Who is running the clinical trial?
Nanjing Immunophage Biotech Co., LtdLead Sponsor
4 Previous Clinical Trials
258 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had any other cancer in the past 3 years.I am 18 years old or older.I am not pregnant or breastfeeding.I have tried all standard cancer treatments without success, or I cannot tolerate them.I have followed the specified timelines for my recent treatments.I still have side effects from previous cancer treatments or surgeries.I have not received a live vaccine in the last 4 weeks and do not plan to during the study.My cancer is advanced or has come back, cannot be surgically removed, and has spread.I am a man with a partner who can have children and we agree to use birth control.I have brain or spinal cord cancer that is causing symptoms or hasn't been treated.I am a woman who can have children and I use birth control.I can carry out all my usual activities without help.I am willing and able to follow the study's schedule and requirements.My blood and organ tests meet the required health standards.I can swallow and keep down pills.I am a woman who can have children and my pregnancy test is negative.I have been diagnosed with HIV.I do not have active ulcers or disorders affecting drug processing.I do not have a primary brain tumor, HIV-related cancer, or cancer from an organ transplant.I am taking medication that affects my heart's rhythm.I do not have any uncontrolled diseases or active infections.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 6
- Group 2: Cohort 1
- Group 3: Cohort 2
- Group 4: Cohort 3
- Group 5: Cohort 4
- Group 6: Cohort 5
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What goals are the organizers of this trial seeking to accomplish?
"Nanjing Immunophage Biotech Co., Ltd. states that the primary objective of this trial is to measure any adverse events within a 33 day window. Additionally, they will be evaluating progression-free survival (PFS), area under the serum concentration-time curve (AUC[0-t]), and apparent terminal phase half life (T1/2) as secondary outcomes."
Answered by AI
Has the Food and Drug Administration given its stamp of approval to IPG7236?
"Our evaluation at Power assigned IPG7236 a value of 1 on the safety scale due to its current Phase 1 status, which reflects limited data in regards to efficacy and security."
Answered by AI
Are there vacancies for participants in this clinical research?
"Affirmative. According to information found on clinicaltrials.gov, this trial commenced recruitment on November 15th 2021 and is still seeking participants as of December 1st 2021. 196 individuals are required from a single location."
Answered by AI
How many volunteers are taking part in this research experiment?
"Correct. Database hosted on clinicaltrials.gov confirms that the medical trial, which was initially posted on November 15th 2021, is actively seeking participants. A total of 196 patients must be recruited from one site."
Answered by AI
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