Health TrialsbyHealthPanel

Study of LM-299 in Subjects Advanced Malignant Tumors

ConditionMalignant Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorLaNova Medicines Limited

About this trial

For Phase I Dose Escalation Stage, to assess the safety and tolerability of LM-299 in patients with advanced solid tumors,determine the maximum tolerated dose (MTD) or optimal biological dose (OBD), and explorethe recommended dose for expansion (RDE) in patients with advanced solid tumours..

For Phase II Dose Expansion Stage, to assess the antitumor activity of LM-299 in patients with various 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- 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-299.

Subjects who have received the anti-tumor treatments within the specified time periods prior to the first dosing of LM-299.

Any adverse event from prior anti-tumour therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.

Subjects with uncontrolled tumour-related pain.

Trial design

Design model

Parallel

Treatments tested in this trial

  • LM-299

    Drug

    Q2W/Q3W,Intravenous Drip

Treatment groups

108 Participants
are divided into 2 treatment groups
Group A: LM-299 Dose Escalation at different dose levelsExperimental treatment 1 intervention
Group B: LM-299 Dose Escalation Backfill CohortsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of dose-limitingtoxicity (DLT)

Phase 1

Time frame
53 weeks
2

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Phase 1

Time frame
53 weeks
3

Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage

Phase 1

Time frame
53 weeks
4

Overall Response Rate (ORR)

Phase 2

Time frame
50 weeks

Secondary outcomes

1

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

Phase 1 and 2

Time frame
103 weeks
2

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

Phase 1 and 2

Time frame
103 weeks
3

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

Phase 1 and 2

Time frame
103 weeks
4

PK Parameter:Time of Maximum Observed Concentration (Tmax)

Phase 1 and 2

Time frame
103 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
Apply now