ܵ ӻ
Q901 CDK7 CDK7 õ ž ,
κ ӻ 1 ӻ 1 ӻ ӹ Q901 ۷ι ΰ Դϴ.
2022 02 ̱ FDAκ ӻ 1/2 IND ȹϿ, ѱ ľóκʹ 2023 06 㰡 Ͽϴ. ܵ dose escalation ( 뷮 Ͽ ȯ 뷮 ) ģ 2024 2б ŰƮ ӻ ȹԴϴ.
Q901 ܵӻ (NCT05394103) |
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ӻܰ |
ӻ 1/2 |
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ӻ |
̱ |
ѱ |
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2022.02.08 |
2023.06.21 |
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༺ Ǵ ̼ Ҿ, ż
(castration-resistant prostate cancer, CRPC), HR+
HER2- , ڱó, , Ҽ Ǵ |
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ȯڸ |
ִ 128 ( 70) |
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ǽñⰣ |
Q901 4 1ȸ, 2ָ 1ȸ
ϸ, Ѹָ ǥ |
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ӻ |
Q901 Ȱ ϱ RP2D
ܵ Ѹָ 뷮 Ȯ ϴ ٱ, , 뷮 , , ༺, PK |
MSD(̱ ũ) ߰ ü ('22.09)
- ֿ䳻
Ǵ Q702 ϸ, ̱ ũ ŰƮٿ Q901 ӻ Ͽ, 1) MSD ťƮ ӻ Ἲ ӻȹ , 2) 鿪 Ͽ ƴ϶ ӻ ʿ ŰƮٸ ش ӻ ǽ Դϴ.
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Q901 DNA ջ Ͽ ü Ҿ ϼ ϴ ֽϴ.
ϼ DNA ջ ϴ (DNA Damage Repair, DDR) ϸ ̰ ˴ϴ. ̿ DNA 鼭 ü Ҿ ϼ ̻ ô ǰ, ñؿ ̾ ˴ϴ.
ü Ҿ ŰƮٿ 鿪 FDA 2017 dMMR̳ MSI-H DNA ջ ϴ ̿Ŀ ȯڵ鿡 ŰƮٸ ϴ ġ ֽϴ. 2021, GSK PD-1 鿪 (dostarlimab) dMMR ̸ FDA ҽϴ.
Q901 ϼ ü Ҿ ֱ ü Ҿ Ͽ PD-1, PD-L1 鿪 Ͽ 븦 ֽϴ.
ӻ
2023 ̱ ѱ 9 Ǵ Q901 ӻ1 뷮 ġ 2024 1б Q901 1 ȣ ü 缺 ȯڸ ӻ ȹԴϴ.
ȣ ü 缺 ȯڴ SERD 迭 ȣ ġḦ 1 ġ ް ־, 2 ġ Ǵ CDK4/6 SERD 1 ġ ް ־, CDK4/6 SERD ǥ 1 ġᰡ ǰ ֽϴ.
Q901 CDK4/6 SERD ̻ ȿ ʰ ȯڸ ӻ ȹϰ ֽϴ. Q901 Ÿ CDK7 п ȣ ü迡 CDK4/6 ܹ Q901 CDK7 ذ CDK4/6 ȿ ִٴ ־ ȣ ü 缺 Q901 1 Ǿϴ. ȯڿ Ž ӻ 2024 1б Q901 + SERD ӻ ȹϰ ֽϴ.
Ҽ ӻ
Q901 Ÿ CDK7 ظ ߾ ϳ RB ̸ غ ִٴ , RB ̰ ߰ߵǴ Ҽ ȯڿ ӻ ȹϰ ֽϴ. ӻ ȹ ̱ ϼ ̱ ȸ Ȯϰ Ǿ, ̱ ϼͿ Q901 ȿ Ҽ ȯڿ ϴ ӻ ȹϰ Ǿϴ.
üü (ADC) ڸ , ADC Ȱ Ǵ ϺоӸ ƴ϶ ġɼ ҼϿ Ϸ ̷ ֽϴ.
, ADC ϴ ̼ҸӶ 1 (TOP1i) , õ ADC κ Ͽ Դϴ. , ADC ұϰ ̵鿡Ե TOP1i ľǵ˴ϴ. 2022 ̱ Ͽ (NCI) ߿ ǥ մϴ. TOP1i CDK7 ϰ Ǹ TOP1i TOP1i յ ADC ó ǰ, Ư TOP1i ߰ų ִٴ ҼϿ Ͽϴ.
̱ ϼ ӻ CDK7 Q901 Ͽ ߿ ϴ. CDK7 Q901 TOP1i ADC ϰڴٴ Դϴ. ̱ ϼͰ ο ġ ϴ ŭ ſ Ǵ Դϴ.
̱ ϼʹ ġ Ͽ ο ġ ϴ ǥ ӻ ϰ , ̷ ӻ ̱ ϼͰ Ǿ մϴ. ̱ ϼͿ ߷ Ǵ Ҽ ӻ Ÿ 븸 ȹϰ ֽϴ.
ӻ
2023 Q901 ӻ 1 뷮 , 뷮 18mg/m2 ȣƮ ȯڿ Q901 ܵ ȿ Ȯ߽ϴ.
̶ Ҹ 5 8.5% ʽϴ. Ϲ ȭп ġᰡ Ǵ Ͽ Q901 ܵ ȿ ٴ ſ ̱ 1 ӻ ȹԴϴ.
ӻ 1 ȯ ǰ ־ ŭ 2024 1б ȯ ȯ ۵ ȹϰ ֽϴ.
4) Q901 Ȳ Ȳ
ȭ Palbociclib ü CDK 簳Ǿ, ߽ɿ CDK7 ֽϴ. ȭ CDK4/6 ̴ ȯڵ鿡 ġɼμ Ȯ ֱ Դϴ.
CDK7 ֱ Ͽ ϼ ϰ DNA ջ ϴ ο ̸, Ҽ CDK7 ߿ ֽϴ.
ֿ üδ Ϸ ij(Carrick Therapeutics), ̱ ̷ν(Syros Pharmaceuticals) ý(Exelixis) ֽϴ.
CDK7 ռ ߵǰ ִ ij samuraciclib (CT7001) Դϴ. ӻ 2 HR+/HER2- ȯ Ľε (Fulvestrant) Ʈΰ ü (SERD) ӻ ϰ , p53 ȯڿ ȿ ̰ ֽϴ.
Q901 ü ȿ samuraciclib ̴ ŭ ſ ֽϴ. Q901 p53 ̿ ȿ ŭ Ȱ ֽϴ.
̷ν SY509 ʱ ӻ ٸ ȿ ǥϰ ʽϴ. ý XL-102 쵵 1 ȿ ǥ ̷ ʽϴ.
samuraciclib ȿ ̰ ִ ŭ, Ư Q901 ſ Դϴ.
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