An Open-Label, Dose Escalation, Phase 1 Study of NIB103 in Adult Participants with Mesothelin-Expressing Advanced or Metastatic Solid Tumors
Phase 1 Study of NIB103 in Adult Participants with Solid Tumors
Tanaka Michihiko
Noile-Immune Biotech, Inc.
2-12-10 Shiba-Daimon, Minato-ku, Tokyo
+81-3-5843-7819
dev@noile-immune.com
Clinical Trial Information Contact
Noile-Immune Biotech, Inc.
2-12-10 Shiba-Daimon, Minato-ku, Tokyo
+81-3-5843-7819
dev@noile-immune.com
Recruiting
Nov. 04, 2025
30
Interventional
single arm study
open(masking not used)
uncontrolled control
single assignment
treatment purpose
1) Male or female patients aged >=18 years at the time of signing informed consent.
2) Histologically or cytologically confirmed advanced or metastatic solid tumors who have no option with or are intolerant of
standard therapies with a proven clinical benefit.
3) Mesothelin-expression (>=50% positive on viable tumor cells) must be determined on the tumor by immunohistochemistry
using a validated assay, scoring and staining confirmed by the sponsor prior to leukapheresis.
4) Life expectancy >=12 weeks.
5) Eastern Cooperative Oncology Group performance status of 0 or 1.
6) Participants with adequate organ functions.
7) Participants must have radiographically measurable disease as defined by Response Evaluation Criteria in Solid Tumors,
Version 1.1 (RECIST 1.1).
8) Voluntary written consent must be given before performance of any study-related procedures not part of standard medical
care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
1) Active systemic infections.
2) Known hepatitis B surface antigen (HBsAg) positive, or known or suspected active hepatitis C virus (HCV) infection. Patients
who have positive hepatitis B core antibody (HBcAb) or hepatitis B surface antibody (HBsAb) can be enrolled but must have an
undetectable hepatitis B virus (HBV) viral load. Patients who have positive hepatitis C virus antibody (HCVAb) must have an
undetectable HCV viral load.
3) Coagulation disorders, or other major medical illnesses including respiratory or immune system disease.
4) Participants with high tumor burden at the disease assessment at screening.
5) Participants with current or history of interstitial lung disease.
6) Participants with current or history of significant immune-related adverse events (irAEs) related to treatment with immune
checkpoint inhibitors. Participants with current or history of the following adverse events (AEs) can be enrolled after careful
discussion between the investigator and sponsor: hyperglycemia/diabetes mellitus, thyroid disorder, hypopituitarism, hypoadrenocorticism, asymptomatic elevation in amylase/lipase, and Grade1 or 2 skin toxicity.
7) Participants with known cardiovascular and cardiopulmonary disease defined as unstable angina, clinically significant
arrhythmia, myocardial infarction, congestive heart failure, Left Ventricular Ejection Fraction (LVEF) <45 %, impaired respiratory
function, baseline oxygen saturation <95% on room air. A well-controlled atrial fibrillation would not be an exclusion whereas
uncontrolled atrial fibrillation would be an exclusion.
8) Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of
treatment according to this protocol.
9) Participants who are diagnosed with or treated for another malignancy within 3 years before leukapheresis procedures.
Participants with non-melanoma skin cancer or carcinoma in situ (eg, cervix, bladder, breast) would be included if they were
adequately treated.
10) Any disease requiring systemic steroid treatment.
11) Any prior use of cell and gene therapyies.
12) Previous treatment with any mesothelin-targeted therapy.
13) Any unresolved toxicity of Grade 3 or higher from previous anticancer therapy.
14) Participants with risk of bleeding as judged by the investigator.
15) Presence of central nervous system metastasis or other significant neurological conditions (participants with central
nervous system metastases that have been effectively treated where necessary and stable can be enrolled).
18age old over
No limit
Both
Mesothelin-Expressing Advanced or Metastatic Solid Tumor
NIB103 is administered in a single dose (IV infusion). There are 4 planned dose levels. Dose escalation will be guided by the 3+3
design which is based on the observed DLT rate each dose level.
-ORR, DCR, DOR, TTP, and PFS as assessed by the investigator according to RECIST 1.1 and iRECIST.
-OS
-CK-related parameters evaluated by CAR vector copy number (Cmax, tmax, Clast, tlast and AUC).
-Number and percentage of cases with RCR-positive test results.
