Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0JUOJJ
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| ADC Name |
MHB036C
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| Synonyms |
MHB036C
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| Organization |
Minghui Pharmaceutical (Originator)
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| Drug Status |
Phase 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 |
MH30010008
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Payload Info | ||||
| Payload Target |
DNA topoisomerase 1 (TOP1)
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Target Info | ||||
| Linker Name |
Stable 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 |
2 Trials
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| Oesophageal cancer |
1 Trials
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| Gastric cancer |
1 Trials
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| Pancreatic cancer |
1 Trials
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| Lung cancer |
2 Trials
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| Skin 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 |
1 Trials
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| Prostate cancer |
1 Trials
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| Urothelial cancer |
1 Trials
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| Head and neck cancer |
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 participants (≥18 years, ECOG 0-1) must have advanced solid tumors (e.g., NSCLC, SCLC, PDAC) failing prior therapies, measurable lesions (RECIST v1.1/PCWG3), and adequate organ function (ANC≥1.5×10<sup>9</sup>/L, platelets≥100×10<sup>9</sup>/L, LVEF≥50%). Key exclusions: active CNS metastases, prior same-target therapy, uncontrolled infections (HBV-DNA+/HCV-RNA+), QTcF>450/470ms, immunosuppressive steroid use, or live vaccinations within 4 weeks. NSCLC/SCLC/UC subgroups require prior platinum/ICI failure.
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| Administration Dosage |
MHB036C will be administered intravenously at a frequency of once every 3 weeks (Q3W).
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| Related Clinical Trial | |||||
| NCT Number | NCT05642949 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description | Phase 1/2, Multi-center, Open-label, Dose Escalation and Cohort Expansion Study to Evaluate the Safety/Tolerability, Pharmacokinetics and Efficacy of MHB036C in Participants With Advanced or Metastatic Solid Tumors | ||||
| Primary Endpoint |
Safety endpoints include adverse events (CTCAE v5.0) monitoring from first MHB036C dose through 30 days post-treatment and dose-limiting toxicities (DLTs) assessed within 21 days after initial administration.
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| Other Endpoint |
Pharmacokinetic parameters (Cmax, Tmax, AUC, Ctrough, t1/2, CL) will be evaluated over 5 treatment cycles (21-day cycles) for MHB036C components. Immunogenicity (ADA) and efficacy outcomes (ORR, DOR, DCR, PFS per RECIST v1.1) will be tracked for 24 months.
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Eligible participants (≥18 years, ECOG 0-1) must have treatment-refractory metastatic solid tumors, adequate organ function, and use contraception. Key exclusions include multiple malignancies (5-year window), recent anti-cancer therapies (chemotherapy within 3 weeks, brain metastases unless stable ≥4 weeks), prior same-target therapy, or unresolved toxicities (>CTCAE grade 1).
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| Administration Dosage |
MHB036C IV every 3 weeks
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| Related Clinical Trial | |||||
| NCT Number | NCT06373406 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description | A Phase I/II, Dose Escalation and Dose Expansion Study of MHB036C for Advanced Solid Tumor to Evaluate the Tolerability/Safety, Pharmacokinetics and Efficacy | ||||
| Primary Endpoint |
The study evaluates safety through incidence of adverse events (AEs) monitored until 30 days post-treatment and dose-limiting toxicities (DLTs) defined as MHB036C-related toxicities meeting severity criteria within the first 21-day cycle.
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| Other Endpoint |
Pharmacokinetic analysis includes maximum plasma concentration (Cmax) and AUC calculation from serum concentrations, alongside immunogenicity assessment via anti-drug antibody (ADA) detection. Efficacy is measured by objective response rate (ORR) per RECIST 1.1, tracking complete/partial responses until 30 days post-treatment.
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| Experiment 3 Reporting the Activity Date of This ADC | [3] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT05642949 | Clinical Status | Phase 1/2 | ||
| Clinical Description | Phase 1/2, multi-center, open-label, dose escalation and cohort expansion study to evaluate the safety/tolerability, pharmacokinetics and efficacy of MHB036C in participants with advanced or metastatic solid tumors. | ||||
References