Summary:
Why is the IMP4297 study being done?
The purpose of this study is to find out about the safety and tolerability of IMP4297 in combination with temozolomide to determine if it is an effective treatment for solid tumors. IMP4297 is experimental, which means it is not approved by Health Authorities including the U.S. Food and Drug Administration (FDA) for the treatment of solid tumors. Temozolomide is a chemotherapy drug that is approved by the FDA for the treatment of brain cancer.What happens during the study?
There are 5 study periods: screening, treatment, end of treatment, safety follow-up, and survival follow-up. All aspects of your participation will take place at the study location or at your place of residence.
1
Screening:
You will have health checks and tests to confirm that you are eligible for the study.
You will be given an Informed Consent Form that contains all of the information about the study. This is to make sure that you understand the study and ask any questions you may have. If you agree to participate, you will give your permission by signing this form.
The screening period is up to 28-days before the first dose of the study drug.
2
Treatment
During the treatment period, eligible patients will receive the combination of IMP4297 and Temozolomide in 28-day cycles. The treatment period will continue until unacceptable adverse events, documented disease progression, withdrawal of consent, loss to follow-up, death, or termination of the study (whichever occurs first).
The study medication will be taken daily by mouth.
3
End of Treatment:
The end of treatment visit will be 0-7 days after the last dose date. The end of treatment is the date in which the patient has permanently terminated the study treatment.
4
Safety Follow-Up:
30 days after the last dose
5
Survival Follow-Up:
Every 12 weeks
What treatment will I receive?
You will receive both IMP4297 and Temozolomide daily by mouth.
IMP4297 will be administered daily on days 1-28
Temozolomide will be administered daily on days 1-21 (Temozolomide will not be administered on days 22-28)