LM-302 for Solid Cancer

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

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

17 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

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 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.

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

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

Treatment Details

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).

Participant Groups

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+