A Study of LM-364 as a Single Agent or in Combination With Anti-tumor Therapy in Patients With Advanced Solid Tumors

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLaNova Medicines Limited

About this trial

For Phase I, to assess the safety and tolerability, obtain the recommended phase 2 dose (RP2D)/optimal biologic dose (OBD) and/or Maximum Tolerated Dose (MTD) for LM-364 as a single agent or in combination with tislelizumab in participants with advanced solid tumors.

For Phase II, to assess the preliminary anti-tumor activity of IMP in participants with advanced solid tumors.

Eligibility criteria

Qualifiers

Participants who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.

Participants must be ≥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.

Disqualifiers

Participant in any other clinical trial within 28 days prior to 1st dosing of LM-364.

Any adverse event from prior anti-tumour therapy has not yet recovered to ≤ grade 1 of CTCAE v6.0.

Participants with uncontrolled tumour-related pain.

Use of any live attenuated vaccines within 28 days prior to 1st dosing of LM-364.

Trial design

Treatments tested in this trial

  • LM-364 for injection
  • Tislelizumab

Treatment groups

90 Participants
are divided into 2 treatment groups

Sponsors and collaborators