Study of LM-302 in Patients With Advance Solid Tumors (NCT05161390) | Clinical Trial Compass
CompletedPhase 1/2
Study of LM-302 in Patients With Advance Solid Tumors
China153 participantsStarted 2021-11-26
Plain-language summary
A Phase I/II Study of LM-302 in Patients with CLDN18.2-Positive Advanced Solid Tumors
Who can participate
Age range
18 Years – 80 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
. Subjects who are fully informed of the purpose, nature, method and possible adverse reactions of the study, and are willing to participate in the study and sign the informed consent document prior to any procedure;
. Aged between 18 to 80 years old, male or female when sign the Informed consent form (ICF);
. ECOG score 0-1;
. Life expectancy ≥ 3 months;
. Subjects have histological or cytological confirmation of advanced solid tumors, and are intolerable for available standard therapy, or there is no available standard therapy;
. Claudin18.2(CLDN18.2) status will be tested by immunohistochemistry (IHC) by central lab, the result must be positive;
. At least one evaluable lesion for phase I and one measurable lesion for phase II according to RECIST v1.1;
. Subjects must have the following organ and marrow function in laboratory tests within 7 days prior to the first dose;
Exclusion criteria
. Participate in any other clinical trial within 28 days prior to 1st dosing of LM-302;
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
Dose limiting toxicity (DLT)
Timeframe: Cycle 1 of each cohort. Duration of one cycle is 21 days
2
Adverse Events and Serious Adverse Events
Timeframe: From signing the ICF until 28 days after EOT or accept other anti-cancer therapy
. Subjects with anti-tumor treatment within 21 days prior to 1st dosing of LM-302, including radiotherapy, chemotherapy, biotherapy, endocrine therapy and immunotherapy, etc.
. Any adverse event from prior anti-tumor therapy has not yet recovered to ≤grade 1 of CTCAE v5.0;
. Peripheral sensory or motor neuropathy ≥ grade 2;
. Subjects with uncontrolled tumor-related pain;
. Subjects with known central meningeal metastasis;
. Subjects with known brain metastasis, stable brain metastasis judged by investigator can be included;
. Subjects with uncontrolled third interstitial effusion judged by the investigator to be unsuitable for inclusion;