Health TrialsbyHealthPanel

A Study of LM-350 in Subjects With Advanced Solid Tumours

ConditionMalignant Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLaNova Medicines Limited

About this trial

For Phase I Dose Escalation Stage, to assess the safety and tolerability of LM-350 in patients with advanced solid tumors,determine the maximum tolerated dose (MTD) or optimal biological dose (OBD), and explore the relationship between the biomarkers and the anti-tumor activity of LM-350.

For Phase II Dose Expansion Stage, to assess the preliminary anti-tumor activity of LM-350 in patients with advanced solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.

Participant must be ≥18 years or the legal age of consent at the time of signing the ICF.

Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

Life expectancy ≥ 3 months.

Disqualifiers

Participate in any other clinical trial within 28 days prior to 1st dosing of LM-350.

Subjects who have received treatment with the same targeting.

History of ≥ Grade 3 late diarrhea during or after previous treatment with a topoisomerase inhibitor.

Subjects who have received the following anti-tumor treatments within the specified time periods prior to the first dosing of LM-350.

Trial design

Design model

Sequential

Treatments tested in this trial

  • LM-350 for injection

    Drug

    Q3W,Intravenous Drip

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Phase I Dose Escalation Part and Dose Confirmation PartExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of dose-limitingtoxicity (DLT)

Phase I

Time frame
78 weeks
2

Incidence of Treatment-Emergent Adverse Events (AEs)

Phase I

Time frame
78 weeks
3

Incidence of serious adverse events (SAEs)

Phase I

Time frame
78 weeks
4

Temperature (Celsius)

Phase I

Time frame
78 weeks

Secondary outcomes

1

Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax)

Phase I/II

Time frame
130 weeks
2

PK Parameter:Time of Maximum Observed Concentration (Tmax)

Phase I/II

Time frame
130 weeks
3

PK Parameter: Area Under the Concentration-time Curve(AUC)

Phase I/II

Time frame
130 weeks
4

PK Parameter: Steady State Maximum Concentration(Cmax,ss) PK Parameter: Steady State Maximum Concentration(Cmax,ss)

Phase I/II

Time frame
130 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

LaNova Medicines Limited

Lead sponsor

Source ClinicalTrials.gov
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