Payload Information
General Information of This Payload
| Payload ID | PAY0FSIWQ |
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| Name | ZD02044 |
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| Synonyms |
ZD02044
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| Target | Microtubule (MT) | |||||
| 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
Zanidatamab zovodotin [Phase 1 (discontinued)]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
28%
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| Patients Enrolled |
Eligible patients must have HER2-high advanced cancers (breast/GEA/others) progressing after standard therapies (trastuzumab-based regimens), measurable disease (expansion cohort), ECOG 0-1, adequate organ/cardiac function (LVEF ≥institutional normal).
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| Administration Dosage |
Dose Escalation: ZW49 administered intravenously at dose levels determined by the SMC
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| Related Clinical Trial | |||||
| NCT Number | NCT03821233 | Phase Status | PHASE1 | ||
| Clinical Description |
A Phase 1 Study of ZW49 in Patients With Locally Advanced (Unresectable) or Metastatic HER2-Expressing Cancers
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| Primary Endpoint |
Safety assessments include DLTs (4 weeks), AEs/lab abnormalities/ECG-LVEF changes/dose reductions (7 months) graded by CTCAE v5.0 for ZW49-treated patients.
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| Other Endpoint |
Pharmacokinetics (serum concentrations), immunogenicity (ADAs), and efficacy outcomes (ORR/DCR/DOR/PFS per RECIST 1.1) are evaluated for up to 2 years in ZW49-treated cohorts.
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| Experiment 2 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Disease control rate (DCR) |
72%
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| Patients Enrolled |
Eligible patients must have HER2-high advanced cancers (breast/GEA/others) progressing after standard therapies (trastuzumab-based regimens), measurable disease (expansion cohort), ECOG 0-1, adequate organ/cardiac function (LVEF ≥institutional normal).
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| Administration Dosage |
Dose Escalation: ZW49 administered intravenously at dose levels determined by the SMC
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| Related Clinical Trial | |||||
| NCT Number | NCT03821233 | Phase Status | PHASE1 | ||
| Clinical Description |
A Phase 1 Study of ZW49 in Patients With Locally Advanced (Unresectable) or Metastatic HER2-Expressing Cancers
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| Primary Endpoint |
Safety assessments include DLTs (4 weeks), AEs/lab abnormalities/ECG-LVEF changes/dose reductions (7 months) graded by CTCAE v5.0 for ZW49-treated patients.
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| Other Endpoint |
Pharmacokinetics (serum concentrations), immunogenicity (ADAs), and efficacy outcomes (ORR/DCR/DOR/PFS per RECIST 1.1) are evaluated for up to 2 years in ZW49-treated cohorts.
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Samatatug zovodotin [Phase 1 (discontinued)]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Inclusion Criteria: Adults with inoperable/metastatic solid tumors (specific histologies for each cohort) who exhausted standard therapies. Required: measurable disease (RECIST 1.1), ECOG 0-1, adequate organ function, archived/fresh tumor tissue (≤3 years old), and controlled AEs (CTCAE v5 ≤G1). Exclusion Criteria: Prior disqualifying therapies, untreated brain metastases (unless stable ≥4 weeks post-treatment), major surgery (within 4 weeks), QTcF >480 ms, pregnancy/lactation, hypersensitivity to study drugs, or active malignancies (except cured non-melanoma skin cancers/localized tumors).
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| Administration Dosage |
Dose-escalation followed by cohort-expansion in tumor-specific expansion cohorts
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| Related Clinical Trial | |||||
| NCT Number | NCT04925284 | Phase Status | PHASE1 | ||
| Clinical Description |
A Dose-Escalation and Expansion Study of the Safety and Pharmacokinetics of XB002 as Single-Agent and Combination Therapy in Subjects With Inoperable Locally Advanced or Metastatic Solid Tumors
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| Primary Endpoint |
The study's Dose-Escalation Stage aimed to determine the MTD/recommended dose (RD) of IV XB002 alone or in combination over 18 months. The Cohort-Expansion Stage assessed preliminary efficacy through ORR using RECIST 1.1 (or RANO/PCWG3 criteria) over 12 months.
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| Other Endpoint |
Safety and tolerability were evaluated via AEs/SAEs, treatment duration, and dose intensity over 30 months. Pharmacokinetics (Cmax, Ctrough) and immunogenicity (ADA) of XB002, total antibody, and free payload were analyzed. Anti-tumor activity was measured by ORR, DOR, and PFS (RECIST 1.1/RANO/PCWG3) through investigator/BIRC assessments. Overall survival was tracked in expansion cohorts for 12 months.
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References