A Study of NI-1801 in Patients with Mesothelin Expressing Solid Cancers

Study LCB-1801-001 is an open-label, Phase 1, dose escalation (Part A) and expansion (Part B), first-in-human clinical study of NI-1801 in patients with advanced, metastatic, or recurrent solid malignancies expressing mesothelin (MSLN). The dose escalation part (Part A) of the main study will evaluate the safety and tolerability of escalating doses of NI-1801 to determine the maximum tolerated dose (MTD) and non-tolerated toxic dose (NTD) of NI-1801. The expansion part (Part B) of the main study will further evaluate the safety and efficacy of NI-1801 administered at or below the MTD in up to

Trial Details

NCT ID
NCT05403554
Phase
PHASE1
Sponsor
Light Chain Bioscience - Novimmune SA
Status
RECRUITING
Cancer Type
Adenocarcinoma Lung Cancer
Interventions
  • Biological NI-1801
  • NI-1801 in combination with anti-PD1 (Pembrolizumab)
  • NI-1801 in combination with paclitaxel
  • Paclitaxel
Locations (sample)
  • Paris, France|48.85341,2.3488
  • Paris, France|48.85341,2.3488
  • Rennes, France|48.11109,-1.67431
  • Villejuif, France, France
  • Milan, Italy|42.78235,12.59836

Key Eligibility Criteria

  • Adults ≥ 18 years of age at the time of signing the informed consent form
  • Histologically or cytologically confirmed diagnosis of epithelial OC (high-grade serous or endometroid), TNBC, or non-squamous NSCLC. For the combi…
  • MSLN expression with staining intensity of ≥ 2+ as per IHC in ≥ 40% of tumor cells. Staining for MSLN expression can be performed using archival tu…
  • Patients with advanced, metastatic, or recurrent disease

For full eligibility, visit ClinicalTrials.gov.

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