Monoclonal Antibodies

LM-302 for Solid Tumors

Local Institution - 0013, Duarte, CA

LM-302Phase 1Waitlist AvailableLed by Skeel RolandResearch 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

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upbaseline c1d1through approximately 1 year after first administration of lm302

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Advanced Solid Tumors

Eligibility Criteria

Inclusion Criteria

You will 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 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

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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;

0 / 1Eligibility criteria met

Find a site

Who is running the clinical trial?

LaNova Medicines LimitedLead Sponsor

7 Previous Clinical Trials

1,035 Total Patients Enrolled

Turning Point Therapeutics, Inc.Lead Sponsor

9 Previous Clinical Trials

884 Total Patients Enrolled

Skeel RolandPrincipal Investigator

St. Joseph Heritage Healthcare

Joseph ChaoPrincipal Investigator

City of Hope National Medical Center

5 Previous Clinical Trials

48 Total Patients Enrolled

Ajita NarayanPrincipal Investigator

Horizon Oncology Research, LLC

Jaffer AjaniPrincipal Investigator

The University of Texas MD Anderson

2 Previous Clinical Trials

81 Total Patients Enrolled

Carla KurkjianPrincipal Investigator

Mercy Clinic Oncology and Hematology

Bristol-Myers SquibbStudy Director

Bristol-Myers Squibb

1,460 Previous Clinical Trials

3,319,141 Total Patients Enrolled

Media Library

LM-302 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05001516 — Phase 1

Solid Tumors Research Study Groups: LM302 Dose Escalation Level 5, 2.4mg/kg, LM302 Dose Escalation Level 3, 0.8 mg/kg, LM302 Dose Escalation Level 2, 0.4 mg/kg, LM302 Dose Escalation Level 4, 1.6mg/kg, LM302 Dose Escalation Level 6, 2.8mg/kg, LM302 Dose Escalation Level 1, 0.2 mg/kilogram(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

Recent research and studies

clinicaltrials.govStudy

Study of Turning Point Therapeutics LM-302 in Patients With Advance Solid Tumors

2022. "Study of Turning Point Therapeutics LM-302 in Patients With Advance Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05001516.