Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0YODKD
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| ADC Name |
BIO-106
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| Synonyms |
BIO-106
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| Organization |
Beckley Biopharma (Originator)
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| Drug Status |
Phase 1/2
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| Antibody Name |
Anti-TROP2 antibody
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Antibody Info | ||||
| Antigen Name |
Tumor-associated calcium signal transducer 2 (TACSTD2)
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Antigen Info | ||||
| Payload Name |
TAMTM
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Payload Info | ||||
| Payload Target |
Microtubule (MT)
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Target Info | ||||
| Linker Name |
A non-cleavable linker
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Linker Info | ||||
| Conjugate Type |
Undisclosed
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2027 Update
The indication landscape of This ADC
2027 Update
The clinical trial pipelines of This ADC
| Indication | Phase 1 | Phase 2 | Phase 3 | Approved | ||
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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 must have advanced/metastatic solid tumors with disease progression post-standard therapy, measurable disease (RECIST 1.1 or bone-only), and ECOG 0-1. Exclusions cover drug hypersensitivity, cardiac dysfunction, active infections (HIV/HBV/HCV/SARS-CoV-2), and untreated CNS metastases.
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| Administration Dosage |
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| Related Clinical Trial | |||||
| NCT Number | NCT05320588 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description | A Phase 1/2 Study of BIO-106 As Monotherapy or In Combination With Pembrolizumab in Patients With Advanced Cancers (StarBridge-1) | ||||
| Primary Endpoint |
The Phase 1 escalation period assesses safety (AEs, SAEs, DLTs) over 1 year to determine MTD, while the Phase 2 expansion period evaluates anti-tumor activity through ORR, DCR, DOR, PFS, and OS over 2 years.
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| Other Endpoint |
Phase 1 measures anti-tumor activity (ORR, DCR, DOR, PFS, OS) over 1 year, while Phase 2 monitors AESIs and AEs/SAEs over 2 years. PK parameters (Cmax, AUC) and anti-drug antibodies for BIO-106 are tracked across both phases.
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT05320588 | Clinical Status | Phase 1/2 | ||
| Clinical Description | A phase 1/2 study of BIO-106 as monotherapy or in combination with pembrolizumab in patients with advanced cancers (starbridge-1). | ||||
References