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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
Gastric and gastroesophageal junction adenocarcinoma;
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

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.

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.Check my eligibility
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).See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have cancer in your stomach or the area where your esophagus meets your stomach.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline c1d1through approximately 1 year after first administration of lm302
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline c1d1through approximately 1 year after first administration of lm302 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Electrocardiogram (ECG)-(R wave)RR interval
Change in Electrocardiogram (ECG)-QRS duration
Change in Electrocardiogram (ECG)-QT interval
+11 more
Secondary outcome measures
Area under the serum concentration versus time curve within one dosing interval (AUCtau)
Clearance (CL)
Disease control rate of LM-302.
+10 more
Other outcome measures
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;

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

LM-302 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05001516 — Phase 1
Solid Tumors Research Study Groups: LM302 Dose Escalation Level 4, 1.6mg/kg, LM302 Dose Escalation Level 5, 2.4mg/kg, LM302 Dose Escalation Level 1, 0.2 mg/kilogram(kg),, LM302 Dose Escalation Level 2, 0.4 mg/kg, LM302 Dose Escalation Level 3, 0.8 mg/kg, LM302 Dose Escalation Level 6, 2.8mg/kg
Solid Tumors Clinical Trial 2023: LM-302 Highlights & Side Effects. Trial Name: NCT05001516 — Phase 1
LM-302 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05001516 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~14 spots leftby Mar 2025