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Monoclonal Antibodies
LM-302 for Solid Cancer
Phase 1
Waitlist Available
Led By Skeel Roland
Research Sponsored by LaNova Medicines Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline c1d1through approximately 1 year after first administration of lm302
Awards & highlights
Summary
This trial is testing a new drug called LM-302 in patients with advanced cancers that have a specific protein called CLDN18.2. The drug aims to attach to this protein on cancer cells to help stop their growth. Another drug targeting the same protein has been developed and tested in previous studies.
Who is the study for?
Adults (18+) with advanced solid tumors that have not responded to standard treatments or for whom no standard treatment exists. Participants must be informed about the trial and willing to sign consent, have a life expectancy of at least 3 months, an ECOG performance status of 0-1, and appropriate organ function. CLDN18.2 positive status may be required for certain phases.
What is being tested?
LM-302 is being tested in this Phase I trial on patients with CLDN18.2-positive advanced solid tumors. The study involves increasing doses to find safe levels (dose escalation) followed by further testing at these levels (dose expansion).
What are the potential side effects?
Potential side effects are not specified but could include typical reactions seen with cancer therapies such as fatigue, nausea, immune-related issues, or infusion reactions due to LM-302's nature as a new investigational medication.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline c1d1through approximately 1 year after first administration of lm302
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline c1d1through approximately 1 year after first administration of lm302
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Electrocardiogram (ECG)-(R wave)RR interval
Change in Electrocardiogram (ECG)-QRS duration
Change in Electrocardiogram (ECG)-QT interval
+11 moreSecondary study objectives
Area under the serum concentration versus time curve within one dosing interval (AUCtau)
Clearance (CL)
Disease control rate of LM-302.
+10 moreOther study objectives
To explore the correlation between CLDN18.2 expression and anti-tumor activity of LM-302
Trial Design
6Treatment groups
Experimental Treatment
Group I: LM302 Dose Escalation Level 6, 2.8mg/kgExperimental Treatment1 Intervention
The dose escalation scheme using the the accelerated titration design for dose 1 and the i3+3 design for the remaining doses.
sixth dose: 1.6mg/kg i.v. every 3 weeks (1 cycle=21 days) , n=12;
Group II: LM302 Dose Escalation Level 5, 2.4mg/kgExperimental Treatment1 Intervention
The dose escalation scheme using the the accelerated titration design for dose 1 and the i3+3 design for the remaining doses.
fifth dose: 1.6mg/kg i.v. every 3 weeks (1 cycle=21 days) , n=9;
Group III: LM302 Dose Escalation Level 4, 1.6mg/kgExperimental Treatment1 Intervention
The dose escalation scheme using the the accelerated titration design for dose 1 and the i3+3 design for the remaining doses.
fourth dose: 1.6mg/kg i.v. every 3 weeks (1 cycle=21 days) , n=6;
Group IV: LM302 Dose Escalation Level 3, 0.8 mg/kgExperimental Treatment1 Intervention
The dose escalation scheme using the the accelerated titration design for dose 1 and the i3+3 design for the remaining doses.
third dose: 0.8mg/kg i.v. every 3 weeks (1 cycle=21 days) , n=6;
Group V: LM302 Dose Escalation Level 2, 0.4 mg/kgExperimental Treatment1 Intervention
The dose escalation scheme using the the accelerated titration design for dose 1 and the i3+3 design for the remaining doses.
second dose: 0.4mg/kg i.v. every 3 weeks (1 cycle=21 days) , n=3;
Group VI: LM302 Dose Escalation Level 1, 0.2 mg/kilogram(kg),Experimental Treatment1 Intervention
The dose escalation scheme using the the accelerated titration design for dose 1 and the i3+3 design for the remaining doses.
first dose: 0.2mg/kg i.v. every 3 weeks (1 cycle=21 days) , n=1;
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LM-302
2021
Completed Phase 1
~20
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Targeted therapies for solid tumors, such as those targeting the CLDN18.2 protein, work by specifically binding to proteins that are overexpressed on the surface of cancer cells. This binding can inhibit tumor growth and survival by blocking essential signaling pathways, inducing apoptosis, or delivering cytotoxic agents directly to the cancer cells.
For patients with solid tumors, these therapies offer a more precise treatment option that can minimize damage to healthy tissues and reduce side effects compared to traditional chemotherapy. This precision is crucial for improving the quality of life and outcomes for patients with solid tumors.
Find a Location
Who is running the clinical trial?
LaNova Medicines LimitedLead Sponsor
8 Previous Clinical Trials
655 Total Patients Enrolled
Turning Point Therapeutics, Inc.Lead Sponsor
9 Previous Clinical Trials
860 Total Patients Enrolled
Skeel RolandPrincipal InvestigatorSt. Joseph Heritage Healthcare
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: LM302 Dose Escalation Level 4, 1.6mg/kg
- Group 2: LM302 Dose Escalation Level 3, 0.8 mg/kg
- Group 3: LM302 Dose Escalation Level 1, 0.2 mg/kilogram(kg),
- Group 4: LM302 Dose Escalation Level 6, 2.8mg/kg
- Group 5: LM302 Dose Escalation Level 2, 0.4 mg/kg
- Group 6: LM302 Dose Escalation Level 5, 2.4mg/kg
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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