Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0DQLFD
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| ADC Name |
GQ1010
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| Synonyms |
GQ1010; PBI-410; BHV-1510
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| Organization |
GeneQuantum Healthcare (Originator);Pyramid Biosciences
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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 |
Camptothecin analog
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Payload Info | ||||
| Payload Target |
DNA topoisomerase 1 (TOP1)
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Target Info | ||||
| Linker Name |
A cleavable open-ring linker
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Linker Info | ||||
| Conjugate Type |
Enzymatic Catalysis
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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 |
2 Trials
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| Gastroesophageal junction adenocarcinoma |
1 Trials
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| Gastric cancer |
1 Trials
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| Colorectal cancer |
1 Trials
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| Pancreatic cancer |
1 Trials
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| Biliary tract cancer |
1 Trials
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| Breast cancer |
1 Trials
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| Ovarian cancer |
1 Trials
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| Endometrial cancer |
2 Trials
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| Cervical cancer |
1 Trials
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2027 Update
General Information of The ADMET Data Related to This ADC
Absorption
| Standard Type | Value | Units | Description | Reference |
|---|---|---|---|---|
| Maximum Observed Concentration (Cmax) | 1760 | ug/mL |
TopoIx underwent extensive Good Laboratory Practice toxicity assessments in Sprague-Dawley (SD) rats (payload alone) and as part of the intact ADC in Non-Human Primates. Rats were administered repeated intravenous infusions of 0.5, 1.25, and 2.5 mg/kg of H0011 once a week over 5 doses. The potential toxicity profile of PBI-410 was evaluated in cynomolgus monkeys via repeated intravenous infusions of 10, 30, and 60 mg/kg doses every 3 weeks for 3 doses, followed by a six-week recovery phase.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 235000 | ug*h/mL |
TopoIx underwent extensive Good Laboratory Practice toxicity assessments in Sprague-Dawley (SD) rats (payload alone) and as part of the intact ADC in Non-Human Primates. Rats were administered repeated intravenous infusions of 0.5, 1.25, and 2.5 mg/kg of H0011 once a week over 5 doses. The potential toxicity profile of PBI-410 was evaluated in cynomolgus monkeys via repeated intravenous infusions of 10, 30, and 60 mg/kg doses every 3 weeks for 3 doses, followed by a six-week recovery phase.
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[1] |
Distribution
| Standard Type | Value | Units | Description | Reference |
|---|---|---|---|---|
| Area Under the Concentration-Time Curve (AUC) | 235000 | ug*h/mL |
TopoIx underwent extensive Good Laboratory Practice toxicity assessments in Sprague-Dawley (SD) rats (payload alone) and as part of the intact ADC in Non-Human Primates. Rats were administered repeated intravenous infusions of 0.5, 1.25, and 2.5 mg/kg of H0011 once a week over 5 doses. The potential toxicity profile of PBI-410 was evaluated in cynomolgus monkeys via repeated intravenous infusions of 10, 30, and 60 mg/kg doses every 3 weeks for 3 doses, followed by a six-week recovery phase.
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[1] |
Metabolism
| Standard Type | Value | Units | Description | Reference |
|---|---|---|---|---|
| Area Under the Concentration-Time Curve (AUC) | 235000 | ug*h/mL |
TopoIx underwent extensive Good Laboratory Practice toxicity assessments in Sprague-Dawley (SD) rats (payload alone) and as part of the intact ADC in Non-Human Primates. Rats were administered repeated intravenous infusions of 0.5, 1.25, and 2.5 mg/kg of H0011 once a week over 5 doses. The potential toxicity profile of PBI-410 was evaluated in cynomolgus monkeys via repeated intravenous infusions of 10, 30, and 60 mg/kg doses every 3 weeks for 3 doses, followed by a six-week recovery phase.
Click to Show/Hide
|
[1] |
Excretion
| Standard Type | Value | Units | Description | Reference |
|---|---|---|---|---|
| Area Under the Concentration-Time Curve (AUC) | 235000 | ug*h/mL |
TopoIx underwent extensive Good Laboratory Practice toxicity assessments in Sprague-Dawley (SD) rats (payload alone) and as part of the intact ADC in Non-Human Primates. Rats were administered repeated intravenous infusions of 0.5, 1.25, and 2.5 mg/kg of H0011 once a week over 5 doses. The potential toxicity profile of PBI-410 was evaluated in cynomolgus monkeys via repeated intravenous infusions of 10, 30, and 60 mg/kg doses every 3 weeks for 3 doses, followed by a six-week recovery phase.
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[1] |
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 | [2] | ||||
| 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 | ||||
| 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 | [3] | ||||
| 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 | ||||
| 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