A Phase II Study of SKB264 as Monotherapy or as Combination Therapy in Subjects with Advanced or Metastatic Non-small Cell Lung Cancer

Conditions

Advanced or Metastatic Non-small Cell Lung Cancer

Brief summary

Dose-limiting toxicity (DLT)Incidence and severity of AEs Discontinuation of study treatment due to AEs, ORR per RECIST v1.1: the proportion of subjects with a confirmed complete response (CR) or partial response (PR)

Detailed description

DOR: For subjects with a confirmed CR or PR, DOR is defined as the time from the first documented evidence of CR or PR until radiographic disease progression or death due to any cause, whichever occurs first., PFS: The time from first dose of study intervention to first documentation of radiographic disease progression or death due to any cause, whichever occurs first, OS: The time from first dose of study intervention to death due to any cause., PK parameters including Cmin and Cmax of SKB264-ADC, SKB264-TAB and free KL610023., Anti-drug antibody (ADA) test results of SKB264.

Related papers

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Interventions

DRUGCIMETIDINE

DRUGOSIMERTINIB

DRUGSKB264

DRUGRANITIDINE

DRUG-

DRUGPEMBROLIZUMAB

DRUGPARACETAMOL

DRUGROXATIDINE

DRUGFAMOTIDINE

DRUGNIZATIDINE

DRUGCOMBINATIONS

DRUGCARBOPLATIN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Dose-limiting toxicity (DLT)Incidence and severity of AEs Discontinuation of study treatment due to AEs, ORR per RECIST v1.1: the proportion of subjects with a confirmed complete response (CR) or partial response (PR)	—

Secondary

Measure	Time frame
DOR: For subjects with a confirmed CR or PR, DOR is defined as the time from the first documented evidence of CR or PR until radiographic disease progression or death due to any cause, whichever occurs first., PFS: The time from first dose of study intervention to first documentation of radiographic disease progression or death due to any cause, whichever occurs first, OS: The time from first dose of study intervention to death due to any cause., PK parameters including Cmin and Cmax of SKB264-ADC, SKB264-TAB and free KL610023., Anti-drug antibody (ADA) test results of SKB264.	—

Measure

Time frame

DOR: For subjects with a confirmed CR or PR, DOR is defined as the time from the first documented evidence of CR or PR until radiographic disease progression or death due to any cause, whichever occurs first., PFS: The time from first dose of study intervention to first documentation of radiographic disease progression or death due to any cause, whichever occurs first, OS: The time from first dose of study intervention to death due to any cause., PK parameters including Cmin and Cmax of SKB264-ADC, SKB264-TAB and free KL610023., Anti-drug antibody (ADA) test results of SKB264.

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Countries

Romania, Spain

Outcome results

None listed