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LM-302 for Solid Cancer
Study Summary
This trial is for a new cancer drug, LM-302, which will be tested on patients with CLDN18.2-positive advanced solid tumors. This is the first time LM-302 will be tested on humans. The trial will start with a small group of patients to see how they respond to different doses of LM-302.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You are 18 years old or older and can legally consent to participate in the study, regardless of your gender.You are expected to live for at least three more months.You understand what the study is about, the way it will be conducted, the potential side effects, and you agree to participate by signing an informed consent form.You have been diagnosed with an advanced solid tumor that has come back or did not respond to standard treatments. You cannot tolerate these treatments or there are no other available options. Examples of these tumors include stomach, esophagus, pancreas, liver, colon cancers, and ovarian cancer.The study team will test your tumor tissue for a specific protein called Claudin18.2. This test is not required for you to be enrolled in the study.You have advanced solid tumors that have come back or are not responding to current treatments.You received anti-cancer treatment within 3 weeks before starting LM-302.You have severe pain related to your tumor that is not being managed well.You have a build-up of fluid around your heart or in your lungs or abdomen that is not under control and requires frequent removal.You have a blockage in your stomach, frequent vomiting, uncontrolled or severe bleeding in your digestive tract, or an ulcer within the last 28 days before starting the LM-302 treatment.You have previously had an immunodeficiency disease, an organ transplant, a bone marrow transplant from another person, or a stem cell transplant using your own cells.You are in good physical condition and able to perform daily activities without assistance.You need to have a certain protein called CLDN18.2 in your tumor and it will be checked before you can participate. The study is only looking at specific types of tumors listed in the phase Ib (Dose expansion).You have a serious heart condition.You are allergic or hypersensitive to LM-302 or similar products.You have another type of cancer that needs treatment.You have a mental health condition that may make it difficult for you to follow the study requirements.You have cancer in your stomach or the area where your esophagus meets your stomach.You have pancreatic cancer.You have cancer in your bile duct.
- Group 1: LM302 Dose Escalation Level 4, 1.6mg/kg
- Group 2: LM302 Dose Escalation Level 5, 2.4mg/kg
- Group 3: LM302 Dose Escalation Level 1, 0.2 mg/kilogram(kg),
- Group 4: LM302 Dose Escalation Level 2, 0.4 mg/kg
- Group 5: LM302 Dose Escalation Level 3, 0.8 mg/kg
- Group 6: LM302 Dose Escalation Level 6, 2.8mg/kg
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
In which geographical areas can patients access this research?
"Presently, four different sites are facilitating this research; two of which can be found in Lafayette and Toledo while another is located in Duarte. Other locations may also exist to help reduce the commute for those who enroll."
Could you please provide an update on the enrollment status of this research project?
"Indeed, clinicaltrials.gov reflects that this research endeavour is currently recruiting participants. This trial was initially advertised on February 3rd 2022 and its information has since been updated as of August 10th 2022."
What is the overarching aim of this clinical experiment?
"This clinical trial will assess its efficacy over a single cycle of 21 days. Primary outcomes include changes in vital signs and body temperature, while secondary objectives involve measurement of Maximum serum concentration (Cmax), Area under the serum concentration versus time curve within one dosing interval (AUCtau) , and Time to reach maximum serum concentration (Tmax). Blood samples for PK analysis will be collected at various points during the study as deemed necessary by clinicians."
How many participants are being administered the treatment in this clinical trial?
"Affirmative. According to information posted on clinicaltrials.gov, this research trial is actively seeking patients since it was first advertised on February 3rd 2022 and last updated August 10th 2022. 42 individuals will be recruited across four medical sites."
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