Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0VHVOA
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| ADC Name |
TUB-030
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| Synonyms |
TUB-030
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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-5T4 antibody
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Antibody Info | ||||
| Antigen Name |
Trophoblast glycoprotein (TPBG)
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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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| Head and neck cancer |
1 Trials
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| Lung cancer |
1 Trials
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| Unspecific solid tumor |
1 Trials
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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 | [1] | ||||
| Patients Enrolled |
Eligible patients (≥18 years, ECOG 0-1) had adequate organ function, measurable disease per RECIST v1.1, and resolved prior treatment toxicities (≤grade 1). Exclusions included recent anticancer therapy (<4 weeks/5 half-lives), uncontrolled brain metastases, or inadequate contraception. WOCBP required highly effective contraception during and post-treatment (5 half-lives + 6 months).
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| Administration Dosage |
A complete treatment cycle is defined as 21 calendar days. TUB-030 will be administered as an intravenous (IV) solution on day 1 of each treatment cycle
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| Related Clinical Trial | |||||
| NCT Number | NCT06657222 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description | A Multicenter FIH Dose Escalation and Optimization Phase I/IIa Trial to Investigate Safety, Tolerability, PK, and Efficacy of the 5T4 ADC TUB-030 in Patients with Advanced Solid Tumors (5-STAR 1-01) | ||||
| Primary Endpoint |
The MTD was defined as the highest dose where ≤1 of 3 patients experienced DLTs per NCI CTCAE v5.0, assessed from enrollment until 30 days post-treatment.
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| Other Endpoint |
Safety outcomes included AE incidence, PK parameters (Cmax, Cmin, Tmax, AUC, T1/2), immunogenicity (anti-TUB-030 antibodies), and efficacy (ORR per RECIST 1.1), all evaluated until 30 days post-treatment.
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