LM-302 for Solid Cancer

Recruiting in Palo Alto (17 mi)

+16 other locations

Overseen BySkeel Roland

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: LaNova Medicines Limited

No Placebo Group

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.

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.

Participant Groups

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).

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;