Payload Information
General Information of This Payload
| Payload ID | PAY0VBWWP |
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| Name | Zuvotolimod |
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| Target | Toll-like receptor 8 (TLR8) | |||||
| Structure |
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Each Antibody-drug Conjugate Related to This Payload
Full Information of The Activity Data of The ADC(s) Related to This Payload
Pertuzumab zuvotolimod [Phase 1/2 (discontinued)]
Identified from the Human Clinical Data
| 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
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| Related Clinical Trial | |||||
| NCT Number | NCT05091528 | Phase 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
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| 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.
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| 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.
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| 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.
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| Administration Dosage |
Escalating doses of SBT6050 in Part 1 and recommended dose in Part 2
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| Related Clinical Trial | |||||
| NCT Number | NCT04460456 | Phase 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
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| 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.
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| 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.
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| Experiment 3 Reporting the Activity Date of This ADC | [3] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
7.10%
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| Patients Enrolled |
Patients have HER2-expressing or amplified solid tumors.
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| Administration Dosage |
0.60 mg/kg administered Q2 weeks.
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| Related Clinical Trial | |||||
| NCT Number | NCT04460456 | Phase 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.
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| Experiment 4 Reporting the Activity Date of This ADC | [4] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT05091528 | Phase 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.
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References