IPG7236 Combined With Toripalimab in Participants With Advanced Solid Tumors (NCT07508761) | Clinical Trial Compass
RecruitingPhase 1/2
IPG7236 Combined With Toripalimab in Participants With Advanced Solid Tumors
China52 participantsStarted 2026-06-16
Plain-language summary
Phase 1/2 Study for IPG7236 Combined With Toripalimab in Participants With Advanced Solid Tumors
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
. Written informed consent must be obtained before any study procedure is performed.
. Men or women 18 years of age or older.
. Histologically or cytologically confirmed advanced or recurrent malignant solid tumors that are metastatic or unresectable. (Subjects must submit tumor tissue sections from within the past 5 years for CCR8 expression testing. For subjects without paraffin-embedded tissues, a fine-needle aspiration biopsy may be performed. Subjects who cannot provide tumor tissue sections or undergo biopsy are only eligible for inclusion during the dose escalation phase. During the dose expansion phase, CCR8 positivity must be known or tumor tissue sections must be provided with confirmed CCR8 expression.)
. Subjects must have failed or been intolerant to standard antitumor therapy, or lack a standard treatment regimen, or be deemed by the investigator as currently unsuitable for standard therapy.
. According to the RECIST 1.1 criteria, there is at least one measurable lesion.
. Life expectancy ≥ 3 months.
. Subjects must be able to swallow the oral investigational drug.
. The ECOG performance status score is 0 or 1.
Exclusion criteria
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.
What they're measuring
1
Incidence of Dose-Limiting Toxicity (DLT)
Timeframe: Up to 21 days after first dose (Cycle 1): To determine the DLT according to NCI CTCAE v6.0, and define the Maximum Tolerated Dose (MTD) and RP2D of IPG7236 in combination with toripalimab
2
Percentage of patients with adverse events
Timeframe: From first dose to 90 days after last dose or initiation of new anti-cancer therapy, whichever comes first
. Primary malignant tumors of the central nervous system or malignant tumors associated with human immunodeficiency virus (HIV) .
. Previous use of CCR8-targeted therapy.
. Received the following treatment within the specified time frame:
. Planned major surgery within 4 weeks prior to the first dose administration (excluding minor procedures such as vascular access placement, gastrointestinal/biliary stent placement, or biopsy);
. Immunotherapy or biological therapy administered within 28 days prior to the initial administration;
. Chemotherapy \<21 days prior to the first dose, or mitomycin or nitrosoureas \< 42 days prior, or oral fluoropyrimidines \< 14 days prior;
. Targeted small-molecule therapy or traditional Chinese medicine with antitumor indications administered within 14 days prior to the initial dose;
. Hormone therapy or other adjuvant therapies are not permitted if initiated within 14 days prior to the first dose. Exceptions: anti-estrogen therapy, bisphosphonates, RANKL monoclonal antibodies, somatostatin analogs, and leuprorelin are permitted if initiated ≥ 14 days prior to the first dose.