Purpose: This is a phase Ia, first-in-human study aiming to assess the safety, maximum tolerated dose (MTD), pharmacokinetic (PK) and anti-tumor activity of FCN-437c, CDK4/6 inhibitor, as monotherapy in patients with HR+HER2- ABC (advanced breast cancer) who failed standard of care.
Methods: Regular 3+3 dose escalation design was utilized with starting dose of 50 mg per day for 3 weeks on -1 week off treatment in a 28-day cycle. Seventeen eligible female patients with HR+HER2- ABC were enrolled at different dose levels: 50 mg (n = 3), 100 mg (n = 3), 200 mg (n = 3), 300 mg (n = 6) and 450 mg (n = 2).
Results: Two patients in the 450 mg dose group experienced DLT of grade 4 thrombocytopenia and neutropenia respectively, and no DLT was observed in other dose levels. The most frequently reported TEAEs was hematological, including leukopenia (94.1%), neutropenia (88.2%), anemia (64.7%) and thrombocytopenia (47.1%). Major grade 3-4 TEAEs were neutropenia and leukopenia, occurring in 11 (64.7%) and 8 (47.1%) patients, respectively. The exposure increased almost in proportion to given dose ranging from 50 to 200 mg. At multiple dose levels from 200 to 450 mg, there appeared to be a trend of saturation. MTD was determined to be 300 mg. Of 15 measurable patients, nine (60.0%) had the best response of stable disease and no objective response was observed.
Conclusions: FCN-437c has established an acceptable safety profile with no unexpected signals compared to other CDK4/6 inhibitors. (NCT04488107, Jul 13th 2020)
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Posted 03 Mar, 2021
Invitations sent on 25 Feb, 2021
On 21 Feb, 2021
On 19 Feb, 2021
Posted 03 Mar, 2021
Invitations sent on 25 Feb, 2021
On 21 Feb, 2021
On 19 Feb, 2021
Purpose: This is a phase Ia, first-in-human study aiming to assess the safety, maximum tolerated dose (MTD), pharmacokinetic (PK) and anti-tumor activity of FCN-437c, CDK4/6 inhibitor, as monotherapy in patients with HR+HER2- ABC (advanced breast cancer) who failed standard of care.
Methods: Regular 3+3 dose escalation design was utilized with starting dose of 50 mg per day for 3 weeks on -1 week off treatment in a 28-day cycle. Seventeen eligible female patients with HR+HER2- ABC were enrolled at different dose levels: 50 mg (n = 3), 100 mg (n = 3), 200 mg (n = 3), 300 mg (n = 6) and 450 mg (n = 2).
Results: Two patients in the 450 mg dose group experienced DLT of grade 4 thrombocytopenia and neutropenia respectively, and no DLT was observed in other dose levels. The most frequently reported TEAEs was hematological, including leukopenia (94.1%), neutropenia (88.2%), anemia (64.7%) and thrombocytopenia (47.1%). Major grade 3-4 TEAEs were neutropenia and leukopenia, occurring in 11 (64.7%) and 8 (47.1%) patients, respectively. The exposure increased almost in proportion to given dose ranging from 50 to 200 mg. At multiple dose levels from 200 to 450 mg, there appeared to be a trend of saturation. MTD was determined to be 300 mg. Of 15 measurable patients, nine (60.0%) had the best response of stable disease and no objective response was observed.
Conclusions: FCN-437c has established an acceptable safety profile with no unexpected signals compared to other CDK4/6 inhibitors. (NCT04488107, Jul 13th 2020)
Figure 1
Figure 2
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