TitleResponse Assessment
Number of Patients Screened40
Number of Patients Enrolled33
Number of Patients Evaluable for Toxicity32
Number of Patients Evaluated for Efficacy28
Evaluation MethodRECIST 1.1
Response Assessment CRn = 1 (4%)
Response Assessment PRn = 0 (0%)
Response Assessment SDn = 10 (36%)
Response Assessment PDn = 16 (57%)
Response Assessment OTHERn = 1 (4%)
Outcome Notes
TitleResponse Assessment
Number of Patients Screened40
Number of Patients Enrolled33
Number of Patients Evaluable for Toxicity32
Number of Patients Evaluated for Efficacy28
Evaluation MethodRECIST 1.1
Response Assessment CRn = 1 (4%)
Response Assessment PRn = 0 (0%)
Response Assessment SDn = 10 (36%)
Response Assessment PDn = 16 (57%)
Response Assessment OTHERn = 1 (4%)
Outcome Notes

Of the 28 efficacy-evaluable patients treated with SGN-2FF in part A, a best response of CR was observed in 1 (4%) patient in the 5 g QD dose cohort who had squamous cell carcinoma of the head and neck. The patient had a 100% reduction in tumor burden after 10 cycles (Fig. 4). The objective response rate was 4% (95% confidence interval [CI], 2.5–100), the disease control rate was 39% (95% CI, 71.5–100), and the clinical benefit rate was 18% (95% CI, 47.8–100).

TitleResponse Assessment
Number of Patients Screened40
Number of Patients Enrolled33
Number of Patients Evaluable for Toxicity32
Number of Patients Evaluated for Efficacy28
Evaluation MethodRECIST 1.1
Response Assessment CRn = 1 (4%)
Response Assessment PRn = 0 (0%)
Response Assessment SDn = 10 (36%)
Response Assessment PDn = 16 (57%)
Response Assessment OTHERn = 1 (4%)
Outcome Notes
TitleResponse Assessment
Number of Patients Screened40
Number of Patients Enrolled33
Number of Patients Evaluable for Toxicity32
Number of Patients Evaluated for Efficacy28
Evaluation MethodRECIST 1.1
Response Assessment CRn = 1 (4%)
Response Assessment PRn = 0 (0%)
Response Assessment SDn = 10 (36%)
Response Assessment PDn = 16 (57%)
Response Assessment OTHERn = 1 (4%)
Outcome Notes

Of the 28 efficacy-evaluable patients treated with SGN-2FF in part A, a best response of CR was observed in 1 (4%) patient in the 5 g QD dose cohort who had squamous cell carcinoma of the head and neck. The patient had a 100% reduction in tumor burden after 10 cycles (Fig. 4). The objective response rate was 4% (95% confidence interval [CI], 2.5–100), the disease control rate was 39% (95% CI, 71.5–100), and the clinical benefit rate was 18% (95% CI, 47.8–100).

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