Clinical Trials/NCT06650566

NCT06650566

Recruiting

Phase 1

A Phase I/II, Open-label, Dose Escalation and Dose Expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of LM-299 Injection as Monotherapy or in Combination With Other Anti-tumor Therapies in Patients With Advanced Solid Tumors

LaNova Medicines Limited6 sites in 2 countries108 target enrollmentOctober 9, 2024

ConditionsMalignant Tumors

InterventionsLM-299

DrugsLM-299

Overview

Phase: Phase 1
Intervention: LM-299
Conditions: Malignant Tumors
Sponsor: LaNova Medicines Limited
Enrollment: 108
Locations: 6
Primary Endpoint: Incidence of dose-limitingtoxicity (DLT)
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

October 9, 2024

End Date

July 2027

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

LaNova Medicines Limited

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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-
•Life expectancy ≥ 3 months.
•Patients with advanced solid tumors confirmed by histopathological diagnosis who have failed standard treatment, are intolerant to standard treatment, or for whom standard treatment is currently unsuitable.
•Pre-treatment archived tumour tissue (within 5 years) or fresh samples could be provided for biomarker analysis.
•Must have at least one measurable lesion according to RECIST v1.
•Adequate organ and bone marrow function as defined by protocol.
•Female subjects of childbearing potential or male subjects with partners of childbearing potential agree to use highly effective contraception.
•Subjects who are able to communicate well with investigators and understand and adhere to the requirements of this study.

Exclusion Criteria

•Participate in any other clinical trial within 28 days prior to 1st dosing of LM-
•Subjects who have received the anti-tumor treatments within the specified time periods prior to the first dosing of LM-
•Any adverse event from prior anti-tumour therapy has not yet recovered to ≤ grade 1 of CTCAE v5.
•Subjects with uncontrolled tumour-related pain.
•Subjects with known central nervous system (CNS) or meningeal metastasis.
•Qualitative urine protein results ≥ 3+.
•Clinically significant hemoptysis or tumor bleeding within 2 weeks prior to 1st dosing of LM-
•Any life-threatening bleeding event that occurred within 3 months prior to 1st dosing of LM-
•Subjects with esophageal or gastric varices requiring immediate intervention or a history of variceal bleeding .
•Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh class B or more severe liver cirrhosis.

Arms & Interventions

LM-299 Dose Escalation at different dose levels

Intervention: LM-299

LM-299 Dose Escalation Backfill Cohorts

Intervention: LM-299

Outcomes

Primary Outcomes

Incidence of dose-limitingtoxicity (DLT)

Time Frame: 53 weeks

Phase 1

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

Time Frame: 53 weeks

Phase 1

Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage

Time Frame: 53 weeks

Phase 1

Overall Response Rate (ORR)

Time Frame: 50 weeks

Phase 2

Secondary Outcomes

PK Parameter: Area Under the Concentration-time Curve(AUClast)(103 weeks)
PK Parameter: Area Under the Concentration-time Curve(AUCtau)(103 weeks)
Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax)(103 weeks)
PK Parameter:Time of Maximum Observed Concentration (Tmax)(103 weeks)
PK Parameter: Elimination Half-life (t1/2)(103 weeks)
PK Parameter: Steady State Maximum Concentration(Cmax,ss)(103 weeks)
PK Parameter: Steady State Minimum Concentration(Cmin,ss)(103 weeks)
PK Parameter: Systemic Clearance at Steady State (CLss)(103 weeks)
PK Parameter: Volume of Distribution at Steady-State (Vss)(103 weeks)
PK Parameter: Accumulation Ratio (Rac AUC)(103 weeks)
PK Parameter: Degree of Fluctuation (DF)(103 weeks)
Overall Response Rate (ORR)(53 weeks)
Duration of Response (DOR) in Month(103 weeks)
Disease control rate (DCR) in percentage(103 weeks)
progression-free survival (PFS) in Month(103 weeks)
Overall survival (OS) in Month(103 weeks)
PK Parameter: Accumulation Ratio (Rac Cmax)(103 weeks)