Actively Recruiting
A Study of NI-1801 in Patients with Mesothelin Expressing Solid Cancers
Led by Light Chain Bioscience - Novimmune SA · Updated on 2024-10-29
70
Participants Needed
7
Research Sites
230 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of NI-1801 in Patients with Mesothelin Expressing Solid Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older
- Confirmed diagnosis of epithelial ovarian cancer (high-grade serous or endometroid), triple negative breast cancer, non-squamous non-small-cell lung cancer, or pancreatic adenocarcinoma for combination with pembrolizumab
- Mesothelin expression with staining intensity of 2+ or higher in at least 40% of tumor cells
- Advanced, metastatic, or recurrent disease after at least one prior systemic treatment
- Failed, intolerant to, or not candidates for available therapies that benefit these cancers
- Measurable disease according to RECIST v1.1
- Accessible lesions for biopsies for expansion cohorts
- ECOG performance status 0 or 1
- Negative pregnancy test at inclusion
- Life expectancy of at least 2 months
- Female patients 18 years or older with high-grade serous epithelial ovarian cancer for randomized study arm
- Platinum-resistant disease with specific progression criteria
- Willingness to provide tumor tissue for mesothelin testing
- At least one measurable lesion by RECIST v1.1
- Received 1 to 3 prior systemic lines of anticancer therapy appropriate for single-agent treatment
- Stabilized or recovered from prior therapy toxicities
- Major surgery completed at least 4 weeks prior with recovery
- Adequate hematologic, liver, and kidney functions
- Ability to sign informed consent and follow protocol
You will not qualify if you...
- Known hypersensitivity to NI-1801 or its components
- Radiotherapy to target lesions within 4 weeks prior to first NI-1801 dose
- Prior anticancer therapy within 2 weeks or less than 5 half-lives before NI-1801 start (up to 4 weeks max)
- Use of other investigational therapies during study
- Severe cardiac dysfunction (NYHA III-IV)
- Significant liver dysfunction unless due to metastasis
- Known HIV or hepatitis B or C infection; active COVID-19
- Uncontrolled active infections requiring recent intravenous treatment
- Concurrent active malignancy requiring systemic treatment
- Known CNS metastases
- Low platelet count or hemoglobin below thresholds
- Low absolute neutrophil count without recent colony stimulating factors
- Pregnancy or breastfeeding
- Psychiatric illness or substance abuse interfering with consent or compliance
- Significant medical conditions increasing study risk
- Prior treatment with CD47, SIRPα, or mesothelin targeting agents
- Unresolved acute toxic effects from prior treatments except alopecia, anemia, or mild neuropathy
- Legal or mental incapacity preventing informed consent
- History of non-infectious pneumonitis or interstitial lung disease for pembrolizumab cohort
- Known hypersensitivity to pembrolizumab or excipients
- Active or suspected autoimmune disease except certain mild conditions
- Prior organ or tissue transplant
- History of severe toxicity from prior checkpoint inhibitors
- History of myocarditis
- Specific histologies excluded in randomized arm
- Primary platinum-refractory disease
- Prior wide-field radiotherapy affecting significant bone marrow
- Serious concurrent illnesses or infections including hepatitis, HIV, cytomegalovirus
- History of demyelinating disease or Lambert-Eaton syndrome
- Clinically significant cardiac disease with recent events or uncontrolled conditions
- History of cirrhotic liver disease (Child-Pugh B or C)
- Prior known hypersensitivity to monoclonal antibodies
- Pregnancy or lactation
- CNS metastases
- History of other malignancy within 3 years
- Known hypersensitivity reactions to study drugs or excipients
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Institut Curie
Paris, France, 75005
Actively Recruiting
2
Hôpital Européen Georges Pompidou
Paris, France, 75015
Actively Recruiting
3
Centre Eugène Marquis
Rennes, France, 35042
Actively Recruiting
4
Gustave Roussy
Villejuif, France, France, 94800
Actively Recruiting
5
Humanitas Research Hospital
Milan, Italy, 20089
Actively Recruiting
6
Istituto Europeo di Oncologia
Milan, Italy, 20141
Actively Recruiting
7
Centro Ricerche Cliniche Verona
Verona, Italy, 37134
Actively Recruiting
Research Team
C
Clinical Project Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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