MedTrace Logo

Study of LM-061 in Subjects in Advanced Tumors

NCT04737122 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-10-10

No results posted yet for this study

Summary

This is a phase I, open-label, dose escalation study to evaluate the safety, tolerability, PK, and preliminary efficacy of LM-061 in subjects with advanced tumors.

Conditions

  • Advanced Tumours

Interventions

DRUG

LM-061

Oral dose with approximately 240 mL water in the fasting condition, and food will be forbidden 1 h prior to administration and 2h after dose. QD for continuous 28 days, and 4 weeks as one treatment cycle.

DRUG

Toripalimab

For subjects in combination escalation levels, toripalimab will be administered 240mg, IV, every 3 weeks

Sponsors & Collaborators

  • LaNova Medicines Limited

    lead INDUSTRY

Principal Investigators

  • Vinod Ganju · Peninsula & South Eastern Hematology and Oncology group

  • Ganessan Kichenadasse · Southern Oncology Clinical Research Unit

  • Paul De Souza · St George Private Hospital

  • Gary Richardson · Cabrini Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-06
Primary Completion
2022-07-19
Completion
2022-12-01

Countries

  • Australia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04737122 on ClinicalTrials.gov