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

Sponsor
Light Chain Bioscience - Novimmune SA
Study ID
NCT05403554
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Biological NI-1801 — DRUG
    Treatment will be administered in 28-day cycles for up to 12 months until disease progression, unacceptable toxicity, or Investigator/patient decision to withdraw study consent. Each subject will receive the assigned dose of NI-1801 on Cycle 1, Day 1. Subsequent doses will be given Q2W, which may be adjusted to every three weeks if recommended from the ongoing PK/PD model analysis.
  • NI-1801 in combination with anti-PD1 (Pembrolizumab) — DRUG
    In the combination with pembrolizumab cohort, the starting NI-1801 dose will be 300 mg. Pembrolizumab will be administered at the dosage of 400 mg every 6 weeks, in 4 cycles. Pembrolizumab will be administered as first drug; later, NI-1801 will be infused after 30 minutes.
  • NI-1801 in combination with paclitaxel — DRUG
    The experimental arm will receive the investigational drug NI-1801 at the P2RD every two weeks in combination with weekly administration of paclitaxel (80 mg/m\^2) over 4-week cycles. The control arm will be treated with weekly paclitaxel at the same regimen.
  • Paclitaxel — DRUG
    The control arm will be treated with weekly administration of paclitaxel (80 mg/m\^2) over 4-week cycles.

Study Details

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 10 additional subjects in order to determine the recommended Phase 2 dose (RP2D). Treatments will be administered in 28-day cycles for up to 12 months until disease progression, unacceptable toxicity, or Investigator/patient decision to withdraw study consent. The dose escalation part (Part A) of the sub-study will evaluate the safety and tolerability of escalating doses of NI-1801 in combination with anti-PD-1 antibody. The expansion part (Part B) of the sub-study will further evaluate the safety and efficacy of NI-1801 administered in combination with anti-PD-1 antibody at or below the MTD. In the randomized cohort, the experimental arm will receive the investigational drug NI-1801 at the P2RD every two weeks in combination with weekly administration of paclitaxel (80 mg/m\^2) over 4-week cycles. The control arm will be treated with weekly paclitaxel at the same regimen representing one of the standards of care (SoC) in this population. This trial specifically targets patients with platinum-resistant ovarian cancer. This cohort will be made up of 20 evaluable patients, 10 per arm.

Key Dates

Start date
Apr 29, 2022
Status verified
Sep 2024
Primary completion
May 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: NI-1801 Single Agent
    NI-1801 will be evaluated in patients with MSLN-expressing advanced, metastatic solid tumors
  • Experimental: NI-1801 in Combination with Pembrolizumab
    NI-1801 will be evaluated in patients with MSLN-expressing advanced, metastatic solid tumors in combination with anti-PD-1 antibody
  • Active Comparator: Randomized cohort
    In the randomized, open-label cohort design, the experimental arm will receive the investigational drug NI-1801 at the P2RD in combination with weekly administration of paclitaxel (80 mg/m\^2) over 4-week cycles.

Primary Outcome Measure

Dose Limiting Toxicity (DLT) [ Time Frame: Up to 12 months ]

Central Contacts

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