A Phase I/II Study of LM-101 Injection in Patients With Advanced Malignant Tumors

Sponsor
LaNova Medicines Limited
Study ID
NCT05615974
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Malignant Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LM101 — DRUG
    Administered intravenously
  • Toripalimab — DRUG
    Administered intravenously
  • Rituximab — DRUG
    Administered intravenously

Study Details

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

Key Dates

Start date
Jan 11, 2023
Status verified
Dec 2024
Primary completion
Jan 11, 2027
Completion
Jan 11, 2028

Study Design

Enrollment
139 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: LM101 Dose Escalation
  • Experimental: LM101 combination therapy exploratory
  • Experimental: LM101 combination expansion

Primary Outcome Measure

Laboratory tests-Urine Routine test [ Time Frame: 48 weeks ]

Central Contacts