Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0YPVKH
ADC Name
Pertuzumab zuvotolimod
Synonyms
SBT6050; pertuzumab zuvotolimod
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Organization
Silverback Therapeutics (ARS Pharmaceuticals) (Originator)
Drug Status
Phase 1/2 (discontinued)
Drug-to-Antibody Ratio
4
Structure
Antibody Name
Pertuzumab
  Antibody Info 
Antigen Name
Receptor tyrosine-protein kinase erbB-2 (HER2 ECD2); Receptor tyrosine-protein kinase erbB-2 (HER2 ECD4)
  Antigen Info 
Payload Name
Zuvotolimod
  Payload Info 
Therapeutic Target
Toll-like receptor 8 (TLR8)
  Target Info 
Linker Name
Mc-Val-Cit-PABC
  Linker Info 
Conjugate Type
Random Cysteines
Combination Type
zuvotolimod
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
Unspecific solid tumor
1 Trials
Trial ID
NCT04460456
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Click To Hide/Show 4 Activity Data Related to This Level
Standard Type NCT Number Clinical Status Clinical Trial Description
Undisclosed  NCT05091528
PHASE1|||PHASE2
An Open-label, Phase 1/2, Dose-escalation and Expansion Study of SBT6050 Combined With Other HER2-directed Therapies in Subjects With Pretreated Unresectable Locally Advanced and/or Metastatic HER2-expressing or HER2-amplified Cancers

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Undisclosed  NCT04460456
PHASE1
A Phase 1/1B, Open-Label, Dose Escalation and Expansion Study of SBT6050 Alone and in Combination With PD-1 Inhibitors in Subjects With Advanced Solid Tumors Expressing HER2
Objective Response Rate (ORR)  NCT04460456
Phase 1
A phase 1/1b, open-label, dose escalation and expansion study of SBT6050 alone and in combination with PD-1 inhibitors in subjects with advanced solid tumors expressing HER2.
Undisclosed  NCT05091528
Phase 1
An open-label, phase 1/2, dose-escalation and expansion study of SBT6050 combined with other HER2-directed therapies in subjects with pretreated unresectable locally advanced and/or metastatic HER2-expressing or HER2-amplified cancers.

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Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
Click To Hide/Show 4 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [1]
Patients Enrolled
Eligible participants had HER2-positive (IHC 2+/3+ or amplified) advanced/metastatic tumors (breast, CRC, gastric, NSCLC) with measurable disease per RECIST v1.1, plus archived/fresh biopsy and adequate organ function. Exclusions included active brain metastases, uncontrolled ILD/pneumonitis, certain autoimmune diseases, strong CYP2C/CYP3A-interacting medications, or untreated hepatitis/HIV.

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Administration Dosage
Dose range of 0.45 to 0.6 mg/kg by subcutaneous (SC) injection in 21-day cycles
Related Clinical Trial
NCT Number NCT05091528  Clinical Status PHASE1|||PHASE2
Clinical Description An Open-label, Phase 1/2, Dose-escalation and Expansion Study of SBT6050 Combined With Other HER2-directed Therapies in Subjects With Pretreated Unresectable Locally Advanced and/or Metastatic HER2-expressing or HER2-amplified Cancers
Primary Endpoint
The study evaluated dose-limiting toxicities (DLTs) within 21 days in escalation cohorts, along with treatment-emergent adverse events (TEAEs) and lab abnormalities graded by NCI CTCAE v5.0 over 18 weeks. Objective response rate (ORR) by RECIST v1.1 was assessed in expansion cohorts at baseline.
Other Endpoint
Safety data (TEAEs severity) were collected in expansion cohorts at baseline, while ORR was tracked in escalation cohorts over 18 weeks. Duration of response (DoR) and clinical benefit rate (CBR) were monitored for all participants using RECIST v1.1 criteria, with CBR specifically applied to expansion cohorts.
Experiment 2 Reporting the Activity Date of This ADC [2]
Patients Enrolled
Eligible patients had HER2+ advanced tumors, prior treatment exposure, measurable disease per RECIST 1.1, and adequate organ function; exclusions included active infections, autoimmune diseases, untreated CNS metastases, or hypersensitivity to drug components.
Administration Dosage
Escalating doses of SBT6050 in Part 1 and recommended dose in Part 2
Related Clinical Trial
NCT Number NCT04460456  Clinical Status PHASE1
Clinical Description A Phase 1/1B, Open-Label, Dose Escalation and Expansion Study of SBT6050 Alone and in Combination With PD-1 Inhibitors in Subjects With Advanced Solid Tumors Expressing HER2
Primary Endpoint
The study evaluated dose-limiting toxicities within 28 days (Parts 1/3), adverse event incidence/severity (all parts) over 2 years, and objective response/duration (Parts 2/4/5) across the 2-year timeframe.
Other Endpoint
Assessments included response rates/duration (Parts 1/3), disease control (all parts), pharmacokinetic parameters (Cmax, AUC), immunogenicity (Parts 1/2), and progression-free survival (Parts 2/4/5) with 2-year follow-up.
Experiment 3 Reporting the Activity Date of This ADC [3]
Efficacy Data Objective Response Rate (ORR)
7.10%
Patients Enrolled
Patients have HER2-expressing or amplified solid tumors.
Administration Dosage
0.60 mg/kg administered Q2 weeks.
Related Clinical Trial
NCT Number NCT04460456  Clinical Status Phase 1
Clinical Description A phase 1/1b, open-label, dose escalation and expansion study of SBT6050 alone and in combination with PD-1 inhibitors in subjects with advanced solid tumors expressing HER2.
Experiment 4 Reporting the Activity Date of This ADC [4]
Related Clinical Trial
NCT Number NCT05091528  Clinical Status Phase 1
Clinical Description An open-label, phase 1/2, dose-escalation and expansion study of SBT6050 combined with other HER2-directed therapies in subjects with pretreated unresectable locally advanced and/or metastatic HER2-expressing or HER2-amplified cancers.
References
Ref 1 A Safety and Activity Study of SBT6050 in Combination With Other HER2-directed Therapies for HER2-positive Cancers
Ref 2 A Study of SBT6050 Alone and in Combination With PD-1 Inhibitors in Subjects With Advanced HER2 Expressing Solid Tumors
Ref 3 A Phase I Pharmacokinetic (PK) and Safety Study of Trph-222 in Patients with Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (R/R NHL): Dose-Escalation Results. 2020 Dec 7.
Ref 4 An Open-label, Phase 1/2, Dose-escalation and Expansion Study of SBT6050 Combined With Other HER2-directed Therapies in Subjects With Pretreated Unresectable Locally Advanced and/or Metastatic HER2-expressing or HER2-amplified Cancers, NCT05091528