C5731005 _ A Phase 2 Basket Study of Disitamab Vedotin in Adult Subjects with Previously Treated, Locally-Advanced Unresectable or Metastatic Solid Tumors That Express HER2

Conditions

Carcinoma, Endometrial Neoplasms, Head and Neck, Non-Small-Cell Lung, Ovarian Neoplasms

Brief summary

Confirmed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as assessed by the investigator.

Detailed description

Type, incidence, severity, seriousness, and relatedness of adverse events (AEs) including AEs of special interest (AESIs)., Type, incidence, and severity of laboratory abnormalities as well as significant changes from baseline, Frequency of treatment interruptions, dose reductions and treatment discontinuations due to AEs., Confirmed disease control rate (DCR) per RECIST v1.1 as assessed by the investigator, Duration of response (DOR) per RECIST v1.1 as assessed by the investigator, Progression free survival (PFS) per RECIST v1.1 as assessed by the investigator, Overall survival (OS), Select PK parameters of disitamab vedotin, total antibody (TAb) and unconjugated MMAE, Incidence of antidrug antibodies (ADA) against disitamab vedotin

Related papers

No related papers found yet.

Interventions

DRUGDisitamab Vedotin

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Confirmed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as assessed by the investigator.	—

Secondary

Measure	Time frame
Type, incidence, severity, seriousness, and relatedness of adverse events (AEs) including AEs of special interest (AESIs)., Type, incidence, and severity of laboratory abnormalities as well as significant changes from baseline, Frequency of treatment interruptions, dose reductions and treatment discontinuations due to AEs., Confirmed disease control rate (DCR) per RECIST v1.1 as assessed by the investigator, Duration of response (DOR) per RECIST v1.1 as assessed by the investigator, Progression free survival (PFS) per RECIST v1.1 as assessed by the investigator, Overall survival (OS), Select PK parameters of disitamab vedotin, total antibody (TAb) and unconjugated MMAE, Incidence of antidrug antibodies (ADA) against disitamab vedotin	—

Measure

Time frame

Type, incidence, severity, seriousness, and relatedness of adverse events (AEs) including AEs of special interest (AESIs)., Type, incidence, and severity of laboratory abnormalities as well as significant changes from baseline, Frequency of treatment interruptions, dose reductions and treatment discontinuations due to AEs., Confirmed disease control rate (DCR) per RECIST v1.1 as assessed by the investigator, Duration of response (DOR) per RECIST v1.1 as assessed by the investigator, Progression free survival (PFS) per RECIST v1.1 as assessed by the investigator, Overall survival (OS), Select PK parameters of disitamab vedotin, total antibody (TAb) and unconjugated MMAE, Incidence of antidrug antibodies (ADA) against disitamab vedotin

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Countries

France, Germany, Italy, Spain

Outcome results

None listed