Payload Information
General Information of This Payload
| Payload ID | PAY0CUVEM |
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| Name | MH30010008 |
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| Synonyms |
MH30010008
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| Target | DNA topoisomerase 1 (TOP1) | |||||
Each Antibody-drug Conjugate Related to This Payload
Full Information of The Activity Data of The ADC(s) Related to This Payload
MHB036C [Phase 2]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT05642949 | Phase 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.
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| Experiment 2 Reporting the Activity Date of This ADC | [3] | ||||
| 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≥1.5×109/L, platelets≥100×109/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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| NCT Number | NCT05642949 | Phase 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
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| 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 3 Reporting the Activity Date of This ADC | [4] | ||||
| 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 | Phase 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
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| 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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MHB088C [Phase 3]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Eligible participants (≥18 years, ECOG 0-1) must have advanced/metastatic solid tumors (NSCLC, SCLC, ESCC, CRPC, MEL, CRC, PDAC, HNSCC, HCC, OC, EC, TC, or SARC) refractory to standard therapies, measurable lesions per RECIST v1.1 (or PCWG3 for CRPC), and adequate organ function. Exclusions: active infections (HBV/HCV/HIV, COVID-19), uncontrolled cardiovascular/neurological conditions, recent major surgery/immunosuppressants, brain metastases (unless stable ≥1 month), prior MHB088C-targeted therapy, pregnancy/breastfeeding, or investigator-assessed ineligibility. Contraception is mandated during and for 90 days post-treatment.
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| Administration Dosage |
MHB088C will be administered intravenously at a frequency of once every 2 weeks (Q2W).
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| Related Clinical Trial | |||||
| NCT Number | NCT05652855 | Phase Status | PHASE1|||PHASE2 | ||
| Clinical Description |
Phase 1/2, Two-Part, Multi-center, Open-label, Dose Escalation and Dose Expansion First-In-Human Study to Evaluate the Safety/Tolerability, Pharmacokinetics and Efficacy of MHB088C in Participants With Advanced or Metastatic Solid Tumors
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| Primary Endpoint |
This clinical trial assesses safety by monitoring adverse events (AEs) per NCI-CTCAE v5.0 and dose-limiting toxicities (DLTs) over one year to establish the maximum tolerated dose (MTD) and recommend a Phase 2 dose (RP2D) of MHB088C. Efficacy is measured via objective response rate (ORR) based on RECIST v1.1 criteria for complete (CR) or partial response (PR).
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| Other Endpoint |
Pharmacokinetic parameters-such as Cmax, Tmax, AUC, Ctrough, t1/2, and systemic clearance (CL)-are evaluated for MHB088C, total antibody, and free toxin MH30010008 over five 28-day cycles. Immunogenicity is assessed via anti-drug antibody (ADA) testing, while efficacy outcomes include duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), and RECIST v1.1-defined tumor progression over one year.
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References