General Information of This Antibody
Antibody ID
ANTI0MWWFT
Antibody Name
Ruzaltatug
Synonyms
Ruzaltatug
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Antigen Name
Receptor tyrosine-protein kinase erbB-3 (ERBB3)
 Antigen Info 
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Each Antibody-drug Conjugate Related to This Antibody
Full Information of The Activity Data of The ADC(s) Related to This Antibody
Ruzaltatug rezetecan [Phase 3]
Identified from the Human Clinical Data
Click To Hide/Show 12 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [1]
Efficacy Data Objective Response Rate (ORR)
39.10%
Patients Enrolled
Eligible patients have histologically confirmed advanced/metastatic solid tumors refractory to standard therapy, ≥1 measurable lesion (RECIST v1.1), ECOG 0-1, life expectancy ≥12 weeks, and adequate organ function. Exclusions include active CNS metastases, recent antitumor therapy (≤4 weeks), prior topoisomerase-I ADC treatment, severe CV/cerebrovascular disease, recent infection (≤4 weeks), or unresolved prior treatment toxicities (Grade >1).

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Administration Dosage
SHR-A2009 was given at doses of 1.5-10.5 mg/kg (Q3W, iv) in an i3+3 dose escalation scheme, followed by cohort expansion at selected doses
Related Clinical Trial
NCT Number NCT05114759  Clinical Status PHASE1
Clinical Description
A Phase I, Open-Label, Multicenter Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-A2009 for Injection in Patients With Advanced Solid Tumors
Primary Endpoint
The Phase 1 study evaluates MTD/MAD (Days 1-21) and DLTs during the first cycle. RP2D will be determined based on MTD/MAD, PK, and efficacy data (Days 1 to 90 post-last dose). Safety is assessed through AEs/SAEs (CTCAE v5.0) during the same period.
Other Endpoint
PK parameters include Tmax, Cmax, AUC0-t, and AUC0-∞ (≤6 months), while immunogenicity (ADA) is tracked for ≤9 months. Efficacy measures (ORR, DoR, DCR, PFS; ≤36 months) are assessed per RECIST 1.1 in later phases.
Experiment 2 Reporting the Activity Date of This ADC [2]
Patients Enrolled
Eligible participants are women (18-75) with metastatic/locally advanced breast cancer (ER+/HER2± or TNBC), ECOG 0-1, measurable lesions per RECIST v1.1, and adequate organ function. Exclusions include active CNS metastases, uncontrolled infections, severe cardiovascular/autoimmune diseases, recent immunosuppression, untreated hepatitis, concurrent malignancies, HIV/organ transplant history, or drug component allergies.

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Related Clinical Trial
NCT Number NCT06222879  Clinical Status PHASE1|||PHASE2
Clinical Description
A Multi-center, Open-label Phase Ib/II Clinical Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-8080 or SHR-A2009 Combined With Anti-tumor Therapy in Patients With Unresectable or Metastatic Breast Cancer
Primary Endpoint
Phase 1 assesses safety through DLT evaluation (21-day cycle) to establish MTD and RP2D, while monitoring AEs/SAEs (CTCAE v5.0) for 12 months. Phase 2 measures efficacy via ORR over 12 months.
Other Endpoint
Immunogenicity assessments track ADA/Nab levels for SHR-A1811, SHR-A2009, and adebrelimab in both phases (12 months). Efficacy measures (ORR, BOR, DoR, DCR, CBR, PFS) and safety outcomes are evaluated identically across phases for 12 months.
Experiment 3 Reporting the Activity Date of This ADC [3]
Patients Enrolled
Eligible participants are adults (≥18) with locally advanced/metastatic breast cancer (any HR status) who received prior ADCs and CDK4/6 inhibitors (HR+), have measurable disease (RECIST 1.1), and adequate organ function. Exclusions include active CNS metastases, uncontrolled HBV/HCV/HIV, recent immunosuppression/therapy (≤3 weeks), severe cardiac disease, autoimmune disorders, or pregnancy. Lab criteria require ANC≥1.5×10^9/L, PLT≥75×10^9/L, and LVEF≥50%.

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Related Clinical Trial
NCT Number NCT06649331  Clinical Status PHASE2
Clinical Description
Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer:A Prospective, Open-label, Multicenter, Phase II Trial
Primary Endpoint
The primary efficacy endpoint is ORR (≤36 months), defined as complete/partial response per RECIST 1.1 in participants with measurable disease at baseline. Radiographic assessments will determine best overall response.
Other Endpoint
Secondary endpoints include PFS (time to progression/death, ≤36 months), CBR (CR+PR+SD≥24 weeks), and DoR (time from response to progression/death). OS (≤5 years) tracks survival from randomization. Safety evaluates treatment-related AEs (CTCAE v5.0, ≤36 months).
Experiment 4 Reporting the Activity Date of This ADC [4]
Patients Enrolled
Eligible participants are women &ge;18 with HR+/HER2- locally advanced/metastatic breast cancer (ER/PR>10%, HER2 0-1+/FISH-negative) who failed CDK4/6 inhibitors, have measurable lesions (RECIST 1.1), adequate organ function (ANC&ge;1.5&times;10<sup>9</sup>/L, Cr&le;1&times;ULN), and ECOG&le;2. Exclusions include active CNS metastases, recent cardiac events (&le;6 months), major surgery/therapy (&le;3 weeks), pregnancy, or other malignancies (&le;5 years). Contraception is required for 3 months post-treatment.

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Related Clinical Trial
NCT Number NCT05594095  Clinical Status PHASE2
Clinical Description
Precision Platform Study of HR+/ HER2-advanced Breast Cancer Based on SNF Typing (A Prospective, Open-label, Multi-center, Phase II Platform Study)
Primary Endpoint
The primary efficacy endpoint is ORR (≤3 years) defined as the proportion of participants achieving complete or partial response based on RECIST 1.1 criteria during the study period until disease progression or death occurs.
Other Endpoint
Secondary endpoints include CBR (CR+PR+SD≥24 weeks, ≤3 years), PFS (time to progression, RECIST 1.1), OS (time to death, ≤3 years), and CTCAE v5.0 graded AEs (≤1 year). Exploratory biomarker analysis will examine tumor/blood/feces samples for correlations with treatment response.
Experiment 5 Reporting the Activity Date of This ADC [5]
Patients Enrolled
Eligible patients are adults (18-75) with locally advanced/unresectable or metastatic ESCC who progressed after first-line chemo/immunotherapy (PFS&ge;3 months if prior IO), have measurable lesions (RECIST 1.1), ECOG 0-1, adequate organ function (ANC&ge;1.5&times;10<sup>9</sup>/L, LVEF&ge;50%), and tissue for biomarker analysis. Key exclusions: active autoimmune disease, uncontrolled infections (HBV/HCV), recent bleeding/thrombosis, CNS metastases, immunosuppressant use (>10mg/day prednisone), pregnancy, or other malignancies (&le;5 years). Contraception required for 6 months post-treatment.

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Related Clinical Trial
NCT Number NCT03736863  Clinical Status PHASE2
Clinical Description
A Phase II Exploratory Clinical Trial of Multiple Drug Combinations in the Treatment of Advanced Esophageal Squamous Cell Carcinoma
Primary Endpoint
The primary endpoint is ORR (≤1 year), measured as the proportion of patients achieving confirmed complete or partial response (RECIST 1.1) on two consecutive assessments ≥4 weeks apart.
Other Endpoint
Secondary endpoints include DCR (CR+PR+SD, ≤1 year), PFS (time to progression/death, ≤2 years), DoR (response duration), TTR (time to first response, ≤1 year), OS (≤2 years), PFS rates (3-/6-month), OS rates (6-/9-/12-month), and safety (AE monitoring, ≤2 years).
Experiment 6 Reporting the Activity Date of This ADC [6]
Patients Enrolled
Eligible patients (18-75 years) must have metastatic NSCLC (AJCC 8th edition), progressed post standard and ADC therapy, &ge;1 measurable lesion per RECIST 1.1, ECOG 0-1, life expectancy &ge;12 weeks, adequate organ function, and contraceptive agreement. Exclusions: untreated brain/meningeal metastases, symptomatic malignant effusions, prior systemic therapy, major surgery/radiotherapy (&le;4 weeks), second malignancies, active hepatitis/TB, uncontrolled hypertension, unresolved toxicities, severe prior hypersensitivity, or other conditions that may compromise study integrity.

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Related Clinical Trial
NCT Number NCT06465238  Clinical Status PHASE2
Clinical Description
A Phase II Study of the Efficacy and Safety of SHR-A1921 or SHR-A2009 in Patients With Previously Treated Advanced NSCLC
Primary Endpoint
The primary endpoint is ORR (≤12 months), evaluated by investigators per RECIST v1.1 criteria.
Other Endpoint
Secondary endpoints include PFS (≤12 months), OS (≤24 months), DoR (≤12 months), DCR (≤12 months), TTR (≤12 months), and AEs (severity per CTCAE v5.0, assessed from Day 1 to 90 days post-treatment).
Experiment 7 Reporting the Activity Date of This ADC [7]
Patients Enrolled
Eligible patients are aged 18-75 with unresectable/metastatic non-squamous NSCLC, prior EGFR-TKI failure, &ge;1 measurable lesion (RECIST v1.1), ECOG 0-1, life expectancy &ge;12 weeks, and adequate organ function. Exclusions: active CNS metastases, recent antitumor therapy or major surgery (&le;4 weeks), other malignancies (&le;5 years), interstitial lung disease, severe cardiovascular disorders, active infections (&le;4 weeks), recent thrombosis (&le;3 months), HIV/hepatitis B/C, or hypersensitivity to study drugs.

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Related Clinical Trial
NCT Number NCT06671379  Clinical Status PHASE3
Clinical Description
A Randomized, Open-label, Multicenter, Phase III Study of SHR-A2009 Versus Platinum-based Chemotherapy in EGFR-mutated, Advanced or Metastatic Non-small Cell Lung Cancer After Failure of Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) Therapy
Primary Endpoint
The primary endpoint is PFS (≤32 months), evaluated by Blinded Independent Central Review (BICR) per RECIST v1.1.
Other Endpoint
Secondary endpoints include OS (≤32 months), investigator-assessed PFS (≤32 months), BICR/investigator-assessed DoR (≤32 months), DCR (≤32 months), and AE incidence (Day 1 to 40 days post-treatment).
Experiment 8 Reporting the Activity Date of This ADC [8]
Patients Enrolled
Eligible patients (18-75 years) must have histologically confirmed advanced/metastatic solid tumors, &ge;1 measurable lesion (RECIST v1.1), ECOG 0-1, life expectancy &ge;12 weeks, and adequate organ function. Exclusions: active CNS metastases, untreated spinal compression, uncontrolled pain/effusions, recent antitumor therapy/radiotherapy/surgery (&le;4 weeks), secondary malignancies (&le;3 years), interstitial lung disease, severe cardiocerebrovascular conditions, recent bleeding (&le;3 months), HIV/hepatitis B/C, drug allergies, substance dependence, or psychiatric/pregnancy-related contraindications.

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Related Clinical Trial
NCT Number NCT06474455  Clinical Status PHASE1|||PHASE2
Clinical Description
A Phase IB/II, Open-Label, Multicentre Clinical Study to Evaluate the Safety, Tolerability and Efficacy of SHR-9839 for Injection in Combination With Other Therapies in Patients With Advanced Solid Tumors
Primary Endpoint
In Phase IB, primary endpoints include DLT incidence (first 21 days post-dose) and AE/SAE/lab abnormality frequency/severity (until safety follow-up completion, ≤24 months), assessed via CTCAE v5.0. Phase II evaluates ORR (until progression, ≤24 months) per RECIST 1.1.
Other Endpoint
Phase II secondary endpoints monitor AE/SAE/lab abnormalities (ICF signing to safety follow-up end, ≤24 months), with safety assessed per CTCAE v5.0.
Experiment 9 Reporting the Activity Date of This ADC [9]
Patients Enrolled
Eligible patients must have confirmed metastatic/refractory solid tumors with &ge;1 measurable lesion (RECIST 1.1), ECOG 0-1, life expectancy &ge;12 weeks, and adequate organ function. Exclusions include active CNS metastases, recent antitumor therapy (&le;4 weeks), prior topoisomerase-I ADC use, severe cardiovascular conditions, recent severe infections (&le;4 weeks), or unresolved treatment-related toxicities (Grade>1).

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Related Clinical Trial
NCT Number NCT05394818  Clinical Status PHASE1
Clinical Description
An Open-label, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-A2009 for Injection in Patients With Advanced Solid Tumors
Primary Endpoint
Phase I evaluates MTD/MAD and DLT incidence during the initial treatment cycle (Day 1-90 post-last dose). RP2D will be determined based on safety (MTD/MAD), PK, and efficacy data, with AE/SAE monitoring per CTCAE v5.0 for tolerability assessment.
Other Endpoint
PK analysis includes Tmax, Cmax, AUC0-t, and AUC0-∞ (≤6 months), alongside immunogenicity (ADA, ≤9 months). Efficacy outcomes (ORR, DoR, DCR, PFS; ≤36 months) are evaluated per RECIST 1.1 criteria.
Experiment 10 Reporting the Activity Date of This ADC [10]
Patients Enrolled
Eligible patients (18-75 years) have confirmed advanced/metastatic NSCLC, &ge;1 measurable lesion (RECIST 1.1), ECOG 0-1, and adequate organ function. Exclusions: active CNS metastases, unresolved spinal cord compression, recent antitumor therapy (&le;4 weeks), major surgery/trauma (&le;4 weeks), untreated autoimmune diseases, severe infections (&le;4 weeks), HBV/HIV positivity, or prior severe allergic reactions to monoclonal antibodies or SHR-A2009 components.

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Related Clinical Trial
NCT Number NCT06092268  Clinical Status PHASE1|||PHASE2
Clinical Description
A Phase IB/II, Open-Label, Multicentre Clinical Study to Evaluate the Safety, Tolerability and Efficacy of SHR-A2009 for Injection in Combination With Other Therapies in Patients With Advanced Solid Tumors
Primary Endpoint
The study assesses DLT incidence (Phase IB, first 21 days post-dose) and ORR (Phase II, 2-year follow-up). Safety parameters include AEs and SAEs monitored for 90 days post-treatment in Phase II efficacy expansion.
Other Endpoint
PK evaluation focuses on SHR-A2009 toxin-binding antibodies, total antibodies, and free toxin over ~2 years, alongside plasma concentration and immunogenicity of SHR-A2009/Adebrelimab. Efficacy metrics (DoR, PFS, ORR) track responses up to 2 years, while OS extends to 3 years in Phase IB.
Experiment 11 Reporting the Activity Date of This ADC [11]
Related Clinical Trial
NCT Number NCT05394818  Clinical Status Phase 1
Clinical Description
An open-label, phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-A2009 for injection in patients with advanced solid tumors.
Experiment 12 Reporting the Activity Date of This ADC [12]
Related Clinical Trial
NCT Number NCT05114759  Clinical Status Phase 1
Clinical Description
A phase 1, open-label, multicenter clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-A2009 for injection in patients with advanced solid tumors.
References
Ref 1 A Phase I Clinical Study of SHR-A2009 for Injection in Patients With Advanced Solid Tumors
Ref 2 Study of HRS-8080 or SHR-A2009 Combined With Anti-tumor Therapy in Patients With Unresectable or Metastatic Breast Cancer
Ref 3 Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer
Ref 4 SNF Platform Study of HR+/ HER2-advanced Breast Cancer
Ref 5 A Phase II Exploratory Clinical Trial of Multiple Drug Combinations in the Treatment of Advanced Esophageal Squamous Cell Carcinoma
Ref 6 Clinical Study of SHR-A1921 or SHR-A2009 in Previously Treated Advanced NSCLC
Ref 7 A Study of SHR-A2009 Versus Platinum-based Chemotherapy in EGFR-mutated, Advanced or Metastatic NSCLC
Ref 8 A Phase IB/II Clinical Study of SHR-9839 for Injection Combined With Other Anti-tumor Therapies in Patients With Advanced Solid Tumors
Ref 9 The Clinical Study of SHR-A2009 for Injection in Patients With Advanced Solid Tumors
Ref 10 A Phase IB/II Clinical Study of SHR-A2009 for Injection in Combination With Other Antitumor Therapies in Patients With Advanced Solid Tumors
Ref 11 An Open-label, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-A2009 for Injection in Patients With Advanced Solid Tumors
Ref 12 A Phase I, Open-Label, Multicenter Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-A2009 for Injection in Patients With Advanced Solid Tumors