Antibody Information
General Information of This Antibody
| Antibody ID | ANTI0WSHAY |
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| Antibody Name | A humanized anti-Napi2b Fc-silenced IgG1 mAb |
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| Antigen Name | NaPi-2b |
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Each Antibody-drug Conjugate Related to This Antibody
Full Information of The Activity Data of The ADC(s) Related to This Antibody
TUB-040 [Phase 1/2]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Patients Enrolled |
Eligible patients (≥18 years, ECOG 0-1) had incurable solid tumors refractory to SoC, measurable disease, adequate organ function, and resolved prior toxicities (≤grade 1). Exclusions included topoisomerase-I refractory disease, active ILD/pneumonitis, uncontrolled comorbidities, recent live vaccines, or infections (HBV/HCV/HIV exceptions applied). Contraception was mandatory for FCBP.
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| Administration Dosage |
A complete treatment cycle is defined as 21 calendar days. TUB-040 will be administered as an intravenous (IV) solution on day 1 of each treatment cycle
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| Related Clinical Trial | |||||
| NCT Number | NCT06303505 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description |
A First-in-human Dose Escalation and Optimization Phase I/IIa Study to Investigate Safety, Tolerability, PK, and Efficacy of the NaPi2b ADC TUB-040 in Patients With Platinum-resistant High-grade Ovarian Cancer (PROC) or r/r Adenocarcinoma Non-small Cell Lung Cancer (NSCLC)
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| Primary Endpoint |
The MTD was determined as the highest dose where ≤1 of 3 patients experienced DLTs per NCI CTCAE v5.0, evaluated from enrollment until 30 days post-treatment.
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| Other Endpoint |
PK parameters (Cmax, Cmin, Tmax, AUC, T1/2) for TUB-040 components (ADC, mAb, payload) and immunogenicity (anti-TUB-040 antibodies) were assessed until 30 days post-treatment, alongside efficacy (ORR per RECIST 1.1).
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References