Study of LM-299 in Subjects Advanced Malignant Tumors

NCT06650566 | Recruiting Phase 1

• 1 other identifier: LM299-01-102
• Study Type: interventional
• Target: 108
• Locations: 2 countries
• Sites: 6

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.

Conditions

Malignant Tumors

Outcome Measures

Primary Outcomes (4)

• Incidence of dose-limitingtoxicity (DLT)

  Phase 1

  53 weeks

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

  Phase 1

  53 weeks

• Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage

  Phase 1

  53 weeks

• Overall Response Rate (ORR)

  Phase 2

  50 weeks

Secondary Outcomes (17)

• 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

Study Arms (2)

LM-299 Dose Escalation at different dose levels

EXPERIMENTAL

Drug: LM-299

LM-299 Dose Escalation Backfill Cohorts

EXPERIMENTAL

Drug: LM-299

Interventions

LM-299 DRUG

Q2W/Q3W,Intravenous Drip

LM-299 Dose Escalation Backfill Cohorts; LM-299 Dose Escalation at different dose levels

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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 v1.1.
• 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.

You may not qualify if:

• 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.
• 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-299.
• Any life-threatening bleeding event that occurred within 3 months prior to 1st dosing of LM-299.
• 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.
• Subjects who have clinically uncontrollable third-space fluid accumulatio.
• Radiographic evidence of tumor invading surrounding vital organs or the risk of esophagotracheal fistula or esophagopleural fistula, tumor surrounding or invading the major blood vessels, or presence of intratumoral cavity formation.
• History of gastrointestinal perforation and/or fistula within 6 months prior to the first dose of the study drug.
• Patients with complete or incomplete intestinal obstruction within 3 months prior to the first dose of the study drug or patientswho are currently at the risk of intestinal perforation.
• Subjects who are known to be allergic to antibody treatment.

Sponsors & Collaborators

• LaNova Medicines Limited: lead

Study Sites (6)

One Clinical Research

Perth, Western Australia, Australia

NOT YET RECRUITING

the first affiliated hospital of Xinxiang medical University

Xinxiang, Henan, China

NOT YET RECRUITING

Liaocheng people's hospital

Liaocheng, Shandong, China

NOT YET RECRUITING

Zibo municipal hospital

Zibo, Shandong, China

NOT YET RECRUITING

Shanghai Dongfang Hospital (Tongji University Affiliated Dongfang Hospital)

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

Shanghai GoBroad Cancer Hospital China Pharmaceutical University

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Alex Yuan

CONTACT

+8615901815211; alexyuan@lanovamed.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 21, 2024
• Study Start: October 9, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 2, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); CN (5)