What side effects are associated with this type of intervention?

Common treatments for solid tumors, especially those targeting specific proteins like CLDN18.2, often involve targeted therapies and immunotherapies. These treatments can cause gastrointestinal issues such as diarrhea, nausea, and vomiting, as well as fatigue and skin reactions like rash. Hematologic toxicities, including neutropenia and anemia, are also frequent. Additionally, organ-specific toxicities such as liver impairment and cardiovascular effects, including hypertension and thromboembolic events, may occur.

What prior FDA approvals exist?

The FDA has approved several targeted therapies for the treatment of solid tumors. For instance, pembrolizumab and nivolumab are immune checkpoint inhibitors that target PD-1/PD-L1 pathways and have been approved for various solid tumors, including melanoma and non-small cell lung cancer. Additionally, trastuzumab targets the HER2 protein and is approved for HER2-positive breast and gastric cancers. While specific FDA approvals for drugs targeting CLDN18.2 in solid tumors are not mentioned, the development of LM-302 represents a similar approach in targeting specific proteins expressed in cancer cells.

What other types of research exist?

Promising alternatives to LM-302 for solid tumors include: 1) Hu14.18K322A, a humanized anti-GD2 monoclonal antibody, particularly for neuroblastoma and osteosarcoma. 2) MLN2704, a prostate-specific membrane antigen-targeted monoclonal antibody-chemotherapeutic conjugate, showing activity in prostate cancer metastasis. 3) LOP628, an anti-c-KIT antibody-drug conjugate, effective against c-KIT-positive tumors such as GIST and SCLC. 4) Pembrolizumab, an immune checkpoint inhibitor, showing activity in various advanced sarcomas.

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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

No Placebo-Only Group

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

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

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 more

Secondary study objectives

Area under the serum concentration versus time curve within one dosing interval (AUCtau)

Clearance (CL)

Disease control rate of LM-302.

+10 more

Other study objectives

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;

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LM-302

2021

Completed Phase 1

~20

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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.