LM-302 for Solid Cancer

No longer recruiting at 16 trial locations

Overseen By First line of the email MUST contain the NCT# and Site #.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: LaNova Medicines Limited

Must not be taking: Anticoagulants, CYP3A4 inhibitors

Disqualifiers: CNS metastasis, Severe cardiovascular, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: Up to 1 year

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial studies a new treatment called LM-302, a potential drug for individuals with advanced solid tumors—cancers that have spread and do not respond to standard treatments. Researchers aim to determine the optimal dose of LM-302 and assess its effects on cancer in the body. The trial is open to those with specific cancer types, such as stomach, pancreatic, or ovarian, particularly if these have recurred or resisted other treatments. Ideal participants have cancers that test positive for the protein CLDN18.2, which is associated with these tumor types. As a Phase 1 trial, this research focuses on understanding how LM-302 works in people, offering participants the chance to be among the first to receive this new treatment.

Do I need to stop my current medications to join the trial?

The trial requires that you stop any anti-tumor treatments at least 21 days before starting the study drug, LM-302. This includes chemotherapy, radiotherapy, and certain oral anti-tumor medications. If you're taking specific medications like nitrosourea or Mitomycin C, a longer period of 42 days is required. Please consult with the trial team for guidance on other medications you may be taking.

Is there any evidence suggesting that LM-302 is likely to be safe for humans?

Research shows that LM-302 has generally been well-tolerated by patients with advanced solid tumors. Studies indicate that the side effects of LM-302 are mostly mild and manageable. In some trials, LM-302 combined with another drug still resulted in manageable side effects. This is encouraging for those considering clinical trials, as it suggests LM-302 may be safe. However, since this is an early phase study, not all possible side effects are known yet. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about LM-302 because it represents a new approach to treating solid cancers. Unlike conventional therapies, which often target cancer cells broadly, LM-302 uses a targeted delivery system, potentially reducing damage to healthy cells and improving safety. This treatment is administered intravenously every three weeks, offering a more manageable schedule compared to some current options. Additionally, LM-302's unique mechanism of action aims to enhance effectiveness by blocking specific pathways that cancer cells use to grow, setting it apart from standard chemotherapy and radiation treatments.

What evidence suggests that LM-302 might be an effective treatment for advanced solid tumors?

Research has shown that LM-302, a treatment targeting the protein CLDN18.2, may help treat advanced solid tumors. In one study, patients' cancer did not worsen for an average of about seven months. After six months, 95% of the patients were still alive, indicating positive outcomes for many. In another case, LM-302 slowed cancer spread in a patient with stomach cancer. This trial will explore various dose levels of LM-302 to determine its effectiveness and safety. These results suggest that LM-302 could be effective for some types of cancer, but further studies are needed to confirm this. ^{1 2 3 6 7}

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.

Exclusion Criteria

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment

Participants receive dose escalation of LM-302 every 3 weeks

Up to 1 year

Every 3 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Long-term follow-up

Participants are monitored for long-term safety and effectiveness

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• LM-302

Trial Overview 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).

How Is the Trial Designed?

Group I: LM302 Dose Escalation Level 6, 2.8mg/kg Experimental Treatment 1 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/kg Experimental Treatment 1 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/kg Experimental Treatment 1 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/kg Experimental Treatment 1 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/kg Experimental Treatment 1 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 Treatment 1 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;

Who Is Running the Clinical Trial?

LaNova Medicines Limited

Lead Sponsor

Trials

13

Recruited

1,400+

Founded

2019

Headquarters

Shanghai, China

Known For

Cancer Therapies

Top Products

LM-299, LM-302, LM-108

Turning Point Therapeutics, Inc.

Lead Sponsor

Trials

10

Recruited

790+

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.3028

A phase 1/2 study of LM-302, an anti-claudin 18.2 ... The median PFS was 7.16 months (95% CI 2.72-NA). The median overall survival (OS) was not reached, with an OS rate of 95.0% at the 6-month (as ...

2. asco.org asco.org/abstracts-presentations/ABSTRACT451248

A phase 1/2 study of LM-302, an anti-claudin 18.2 ... The median PFS was 7.16 months (95% CI 2.72-NA). The median overall survival (OS) was not reached, with an OS rate of 95.0% at the 6-month (as of November 15, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05161390

Study of LM-302 in Patients With Advance Solid Tumors LM-302 Injection with dose escalation stage of different dose levels, as well as dose expansion stage with recommended dose level from dose escalation stage.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12400029/

Complete remission of recurrent gastric cancer in a young ... In this case, LM302 significantly reduced lymph node metastases, whereas ovarian metastases remained stable, ultimately necessitating surgical ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0959804925005945

Tecotabart vedotin in Claudin 18.2-positive advanced ... Tecotabart vedotin (TV; LM-302) is a novel CLDN18. · TV showed manageable safety and promising efficacy in advanced solid tumors. · In CLDN18.

6. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.4039

Efficacy and safety of LM-302 (anti-claudin 18.2 ADC) in ... Conclusions: LM-302 combined with toripalimab demonstrated encouraging anti-tumor activity and manageable safety as first-line treatment for ...

7. trial.medpath.com trial.medpath.com/clinical-trial/612a7358f6687cc8/nct05161390-safety-tolerability-lm-302-cldn18-2-tumours

Study of LM-302 in Patients With Advance Solid Tumors Subjects have histological or cytological confirmation of advanced solid tumors, and are intolerable for available standard therapy, or there is no available ...