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LM-302 + Toripalimab in Advanced Solid Tumors
NCT05188664Phase 2
Key facts
- Status
- Completed
- Start
- May 2022
- Primary completion
- Nov 2023
- Countries
- 1
- Sponsor
- LaNova Medicines
- Modality
- Monoclonal Antibodies, Antibody-Drug Conjugates (ADCs), Small Molecules
- Drugs
- tpx-4589
- Conditions
- solid tumor
01
Overview
Phase 2, open-label trial of tpx-4589 in solid tumor (3 arms), sponsored by LaNova Medicines. Primary endpoints: Dose-Limiting Toxicity, Recommended Phase 2 Dose up to 6 months and 2 more. Started May 2022; status: completed.
02
Design
3 arms- Study design
- Non-randomizedOpen-label
LM-302 monotherapy dose escalation
LM-302 monotherapy
LM-302 in combination therapy dose escalation
LM-302 + Toripalimab
LM-302 Dose Expansion
LM-302 + Toripalimab
03
Who it enrols
Adult patients with recurrent or refractory advanced solid tumors who have progressed on or are intolerant to standard therapy. Patients must have adequate organ function. CLDN18.2 testing is required if tissue is available.
04
Endpoints
Primary
Dose-Limiting Toxicity
Recommended Phase 2 Dose
Optimal Biological Dose
Maximum Tolerated Dose
Secondary
Safety and Tolerability
Pharmacokinetics
Immunogenicity
Preliminary Efficacy
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