Linker Information
General Information of This Linker
| Linker ID |
LIN0LNLKT
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| Name |
A cleavable open-ring linker
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| Linker Type |
Unclear
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| Antibody-Linker Relation |
Cleavable
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Each Antibody-drug Conjugate Related to This Linker
Full Information of The Activity Data of The ADC(s) Related to This Linker
GQ1010 [Phase 1/2]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Patients Enrolled |
Key eligibility: Adults (≥18) with advanced solid tumors (RECIST 1.1 measurable, ECOG 0-1) refractory to standard therapies, requiring adequate organ function. Exclusions: active brain metastases, ILD history, prior Trop-2 therapy, or combination-specific contraindications (e.g., cemiplimab hypersensitivity, Grade 3+ immune-related AEs). Pregnancy and recent anticancer therapies/surgeries are prohibited.
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| Administration Dosage |
BHV-1510 will be administered as an IV infusion on Day 1 every 3 weeks
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| Related Clinical Trial | |||||
| NCT Number | NCT06384807 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description |
A Phase 1/2, First in Human, Dose Escalation and Dose Expansion Study of BHV-1510 (Previously PBI-410) as Monotherapy and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Tumors
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| Primary Endpoint |
Primary endpoints assess safety (AE/SAE/DLT incidence per NCI CTCAE v5.0) and dose determination (RDE/MTD) for BHV-1510 monotherapy and combination with cemiplimab in Phase 1, while Phase 2 focuses on ORR per RECIST 1.1 for monotherapy, all evaluated over approximately 47 months.
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| Other Endpoint |
Secondary objectives include PK parameters (Cmax/AUC/t1/2 within 22 days), immunogenicity (ADA incidence), and efficacy metrics (DOR in Phase 1; DCR/PFS/OS in Phase 2 monotherapy), with tumor response assessed via RECIST 1.1 across both phases.
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Key eligibility: Adults (≥18) with advanced epithelial solid tumors (RECIST 1.1 measurable, ECOG 0-1) refractory to standard therapies, requiring adequate organ function. Exclusions: active infections (HBV/HCV/HIV), severe comorbidities (cardiac/pulmonary/ocular), prior Trop-2/TOP1-ADC therapy, or unresolved Grade 2+ toxicities. Tumor types prioritized include gastric/breast/colorectal cancers.
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| Administration Dosage |
GQ1010 will be administered intravenously every 21 days or every 14 days. Dose Escalation will be guided by Bayesian Optimal Interval (BOIN) Design.
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| Related Clinical Trial | |||||
| NCT Number | NCT06464055 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description |
A Phase I/II, Multicenter, Open-Label, Dose-Escalation and Extension Study of GQ1010 (an Anti-Trop2 ADC) in Subjects With Advanced Solid Tumors
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| Primary Endpoint |
Primary endpoints evaluate safety (AE/SAE/DLT incidence per NCI-CTCAE v5.0) and dose determination (MTD/RDE/RP2D) in Phase Ia/Ib, while Phase II focuses on ORR per RECIST 1.1, all assessed over approximately 1 year.
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| Other Endpoint |
Secondary objectives include PK parameters (Cmax/Tmax/AUC/t1/2), immunogenicity (ADA), and efficacy metrics (ORR/DOR/DCR/PFS/OS per RECIST 1.1), with tumor response requiring confirmed CR/PR assessments.
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References