Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0SBKQZ
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| ADC Name |
TUB-040
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| Synonyms |
TUB-040
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| Organization |
Tubulis (Originator)
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| Drug Status |
Phase 1/2
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| Drug-to-Antibody Ratio |
8
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| Structure |
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| Antibody Name |
Anti-Napi2b Fc-silenced IgG1 mAb
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Antibody Info | ||||
| Antigen Name |
Sodium-dependent phosphate transport protein 2B (SLC34A2)
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Antigen Info | ||||
| Payload Name |
Exatecan
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Payload Info | ||||
| Therapeutic Target |
DNA topoisomerase 1 (TOP1)
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Target Info | ||||
| Linker Name |
P5 (PEG24)-Val-Cit-PABC
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Linker Info | ||||
| Conjugate Type |
Random Cysteines
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| Combination Type |
tubutecan
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The indication landscape of This ADC(2027 Update)
The clinical trial pipeline of This ADC(2027 Update)
| Indication | Phase 1 | Phase 1/2 | Phase 2 | Phase 2/3 | Phase 3 | New Drug Application | Approved | ||
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| Lung cancer |
1 Trials
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| Ovarian cancer |
1 Trials
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General Information of The ADMET Data Related to This ADC(2027 Update)
Excretion
| Standard Type | Value | Units | Description | Reference |
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| Elimination Half-Life (t1/2) | >10 | day |
Allometric scaling and PK/PD modelling predicts a human serum half-life greater 10 days and a therapeutic index in humans up to 55.
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[1] |
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [2] | ||||
| 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) | ||||
| 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