OncoMatch/Clinical Trials/NCT05403554
A Study of NI-1801 in Patients with Mesothelin Expressing Solid Cancers
Is NCT05403554 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Biological NI-1801 and NI-1801 in combination with anti-PD1 (Pembrolizumab) for epithelial ovarian cancer.
Treatment: Biological NI-1801 · NI-1801 in combination with anti-PD1 (Pembrolizumab) · NI-1801 in combination with paclitaxel · Paclitaxel — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Ovarian Cancer
Triple-Negative Breast Cancer
Breast Carcinoma
Non-Small Cell Lung Carcinoma
Pancreatic Cancer
Biomarker criteria
Required: MSLN overexpression (IHC staining intensity ≥ 2+ in ≥ 40% of tumor cells)
MSLN expression with staining intensity of ≥ 2+ as per IHC in ≥ 40% of tumor cells
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic anticancer therapy — primary malignancy
after at least 1 prior systemic treatment for the primary malignancy and who have failed treatment with, are intolerant to, or are not candidates for available therapies that are known to confer a clinical benefit
Cannot have received: CD47 inhibitor
Prior treatment with a CD47...targeting agent
Cannot have received: SIRPA inhibitor
Prior treatment with a...SIRPα...targeting agent
Cannot have received: MSLN targeting agent
Prior treatment with a...MSLN targeting agent
Cannot have received: wide-field radiotherapy affecting at least 20% of the bone marrow
prior wide-field radiotherapy (RT) affecting at least 20% of the bone marrow
Lab requirements
Blood counts
Platelet count lower than 100 x 10^9/L (transfusion support within 14 days before the test is not allowed); Hemoglobin lower than 10.0 g/dL. Prior RBC transfusion is permitted; ANC lower than 1 x 10^9/L (the use of colony stimulating factors, G-CSF or GM-CSF, within 14 days before the test is not allowed)
Kidney function
adequate kidney function required
Liver function
Significant hepatic dysfunction (serum bilirubin ≥ 1.5 mg/dL or AST and/or ALT ≥ 2.5 times normal level), unless related to liver metastasis
Cardiac function
Severe cardiac dysfunction (NYHA classification III-IV); acute myocardial infarction within the last 6 months; unstable angina; uncontrolled congestive heart failure (NYHA > class II); uncontrolled ≥ Grade 3 hypertension; uncontrolled cardiac arrhythmias; LVEF below institutional limit of normal (PLD stratum only); history of hemorrhagic or ischemic stroke within six months prior to randomization
Patients must have adequate hematologic, liver and kidney functions; Severe cardiac dysfunction (NYHA classification III-IV); Significant hepatic dysfunction (serum bilirubin ≥ 1.5 mg/dL or AST and/or ALT ≥ 2.5 times normal level), unless related to liver metastasis; Platelet count lower than 100 x 10^9/L...Hemoglobin lower than 10.0 g/dL...ANC lower than 1 x 10^9/L...clinically significant cardiac disease including...myocardial infarction ≤ 6 months prior to first dose...unstable angina pectoris...uncontrolled congestive heart failure (NYHA > class II)...uncontrolled ≥ Grade 3 hypertension...uncontrolled cardiac arrhythmias...LVEF below institutional limit of normal (PLD stratum only)...history of hemorrhagic or ischemic stroke within six months prior to randomization
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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