TerminatedPhase 1

Study of LM-102 in Subjects in Advanced Tumors

Stopped: Business strategy changed

United States9 participantsStarted 2021-05-27

Plain-language summary

This is a phase Ⅰ, first-in-human, open-label, dose escalation study to evaluate the safety and tolerability, PK, immunogenicity and preliminary anti-tumor activity of LM-102 injection in subjects with CLDN18.2-positive advanced solid tumors.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. PLT ≥ 90 × 109/L; ANC ≥ 1.5 × 109/L; Hemoglobin ≥ 9 g/dL, without receiving EPO, G-CSF, or GM-CSF within 14 days and blood transfusion in at least 7 days;
. Coagulation function: INR ≤ 1.5; APTT ≤ 1.5 × ULN;
. Liver function: Bilirubin ≤ 1.5 × ULN (Subjects with Gilbert's Syndrome are allowed if direct bilirubin is within normal limits); AST and ALT≤ 2.5 × ULN without liver metastases (≤ 5 × ULN if liver metastases are present); Albumin ≥ 2.5 g/dL;
. Kidney function: Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min (using Cockcroft-Gault formula, see Appendix 2); Qualitative urine protein ≤ 1+ or qualitative urine protein ≥ 2+, but 24-hour urine protein \< 1g;
. Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%, QT interval (QTcF) ≤ 470 ms.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with adverse events and serious adverse events

Timeframe: From screening up to 1 year

Maximum tolerated dose (MTD)

Timeframe: Cycle 1 of each cohort. Duration of one cycle is 3 weeks

Dose-limiting toxicities (DLT)

Timeframe: Cycle 1 of each cohort. Duration of one cycle is 3 weeks

Change in Vital Signs-ear temperature

Timeframe: Baseline (Week 0) through approximately 1 year after first administration of LM102

Change in Vital Signs-pluse rate

Timeframe: Baseline (Week 0) through approximately 1 year after first administration of LM102

Change in Vital Signs-blood pressure

Timeframe: Baseline (Week 0) through approximately 1 year after first administration of LM102

Change in Electrocardiogram (ECG)-RR interval

Timeframe: Baseline (Week 0) through approximately 1 year after first administration of LM102

Trial details

NCT IDNCT04735796

SponsorLaNova Medicines Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-05-19

View on ClinicalTrials.gov More Advanced Solid Tumors trials

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. PLT ≥ 90 × 109/L; ANC ≥ 1.5 × 109/L; Hemoglobin ≥ 9 g/dL, without receiving EPO, G-CSF, or GM-CSF within 14 days and blood transfusion in at least 7 days;
. Coagulation function: INR ≤ 1.5; APTT ≤ 1.5 × ULN;
. Liver function: Bilirubin ≤ 1.5 × ULN (Subjects with Gilbert's Syndrome are allowed if direct bilirubin is within normal limits); AST and ALT≤ 2.5 × ULN without liver metastases (≤ 5 × ULN if liver metastases are present); Albumin ≥ 2.5 g/dL;
. Kidney function: Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min (using Cockcroft-Gault formula, see Appendix 2); Qualitative urine protein ≤ 1+ or qualitative urine protein ≥ 2+, but 24-hour urine protein \< 1g;
. Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%, QT interval (QTcF) ≤ 470 ms.

Exclusion criteria

What they're measuring

Number of participants with adverse events and serious adverse events

Timeframe: From screening up to 1 year

Maximum tolerated dose (MTD)

Timeframe: Cycle 1 of each cohort. Duration of one cycle is 3 weeks

Dose-limiting toxicities (DLT)

Timeframe: Cycle 1 of each cohort. Duration of one cycle is 3 weeks

Change in Vital Signs-ear temperature

Timeframe: Baseline (Week 0) through approximately 1 year after first administration of LM102

Change in Vital Signs-pluse rate

Timeframe: Baseline (Week 0) through approximately 1 year after first administration of LM102

Change in Vital Signs-blood pressure

Timeframe: Baseline (Week 0) through approximately 1 year after first administration of LM102

Change in Electrocardiogram (ECG)-RR interval

Timeframe: Baseline (Week 0) through approximately 1 year after first administration of LM102