CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 139 target
Drug / intervention
LM101 +2 moredrug
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Histological or cytological confirmation of recurrent or refractory advanced solid tumors progressed on standard therapy
  • ✓At least one evaluable lesion
  • ✓Archived samples or fresh tumor tissue specimens required for combination therapy group
  • ✓Appropriate organ and marrow function in laboratory examinations within 7 days prior to first dose
Key exclusion· 11
  • ✕Symptomatic/active CNS metastases
  • ✕Prior investigational therapy directed at same target
  • ✕Known hypersensitivity to antibody therapy
  • ✕History of autoimmune disease except autoimmune-related hypothyroidism on stable thyroid replacement

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05615974
NCT05615974Phase 2RecruitingOn TrackUpdated 18mo ago
Long Recruiting
CompareCT.gov

A Phase I/II, Open-label, Dose Escalation, and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of LM-101 Injection as a Single Agent or Combination Therapy in Patients With Advanced Malignant Tumors

LaNova Medicines Limited·interventional·Posted Nov 14, 2022·Updated Dec 19, 2024

In Brief

A Phase 2 clinical trial evaluating LM101, Toripalimab, and 1 other intervention for Malignant Tumors. Currently recruiting, targeting 139 participants across 5 sites.

Detailed Summary

This study is to assess the safety and tolerability, obtain Maximum Tolerated Dose (MTD) and/or the recommended phase 2 dose (RP2D) of LM-101 as a single agent or in combination in patients with advanced malignant tumors

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalignant Tumors
CountriesChina
Collaborators--

Timeline

Phase 2Recruiting
202320242025202620272028
First PostedNov 14, 2022
Enrollment StartJan 11, 2023
Primary CompletionJan 11, 2027
Study CompletionJan 11, 2028
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 3.6 years agoPrimary completion in 6 months

Interventions

LM101drug

Administered intravenously

Toripalimabdrug

Administered intravenously

Rituximabdrug

Administered intravenously