Phase1/2a Study for IPG7236 in Patients With Advanced Solid Tumors (NCT05142592) | Clinical Trial Compass
RecruitingPhase 1/2
Phase1/2a Study for IPG7236 in Patients With Advanced Solid Tumors
United States, China196 participantsStarted 2021-11-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. A written informed consent must be signed prior to performing any study procedures.
. Male or females 18 years or older.
. Diagnosis of advanced or recurrent, histologically or cytologically confirmed, a solid malignancy that is either metastatic or unresectable.
. Subjects must have failed established standard medical anti-cancer therapies for a given tumor type or have been intolerant to such therapy, or in the opinion of the Investigator have been considered ineligible for standard therapies on medical grounds.
. Subjects must demonstrate measurable disease, per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
. Subjects must have a life expectancy of ≥ 3 months.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Subjects must have an Eastern Cooperative Oncology Group(ECOG) performance status score of 0 to 1.
. Subjects must have adequate hematologic and organ function as indicated by the following laboratory values
Exclusion criteria
. Subjects with primary malignancy of the central nervous system or malignancies related to human immunodeficiency virus (HIV) or solid organ transplant.
. Subjects who have not recovered from all toxic effects from prior antitumor therapy or surgical procedures, defined as toxicities (other than alopecia) not yet resolved to Grade ≤ 1 according to NCI CTCAE v5.0.
. Subjects with recent prior therapy defined as
. Any investigational or Food and Drug Administration (FDA)-approved anti-cancer drug within 14 days or 5 half-lives, whichever is longer, prior to the first dose of study drug.
. Any radiotherapy, chemotherapy, targeted therapy or immunotherapy within 14 days or major surgery within 28 days or anti-neoplastic antibody or nitrosoureas/mitomycin C within 42 days prior to the first dose of study drug
. Subjects with any uncontrollable diseases (e.g., severe mental, neurological, cardiovascular, respiratory, and other systemic diseases) or obvious active infections that may affect the clinical study.
. Subjects with positive Coronavirus disease（COVID）-19 PCR tests (patients who recovered from COVID-19 but have positive COVID-19 PCR tests may be included at the judgment of the Investigator)
. Subjects who have received the live or attenuated vaccine within 4 weeks prior to study treatment or intend to receive a live or attenuated vaccine during the study