JP7417527B2 - アゾロピリミジン化合物による投薬 - Google Patents
アゾロピリミジン化合物による投薬 Download PDFInfo
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Description
本出願は、2018年2月16日出願の米国仮出願第62/710,394号の米国特許法第119条(e)項に基づく優先権を主張する出願であり、前記仮出願はあらゆる目的でその全内容が参考により本明細書中に援用される。
〔連邦政府の支援の下で研究と開発がなされた発明の権利に関する声明〕
〔付録として提出する、コンパクトディスク上の「配列表」、表、又はコンピュータ・プログラムリストへの言及〕
アデノシン2A受容体(A 2A R)
アデノシン2B受容体(A 2B R)
〔概論〕
またはその薬学的に許容される塩の約5~250 mgの総1日量を、必要とする対象に投与することによる方法を提供する。
〔定義〕
アデノシンA 2A 受容体およびアデノシンA 2B 受容体並びにそれの阻害
治療方法
またはその薬学的に許容される塩を投与することを含む方法が提供される。
〔治療的および予防的用途〕
〔医薬組成物〕
〔医薬剤形〕
本発明は、任意の適当な方法で化合物Iおよびその組成物を投与することを図る。適当な投与経路としては、経口、非経口〔例えば筋肉内、静脈内、皮下(例えば注射もしくはインプラント)、腹腔内、関節内、腹腔内、脳内(実質内)および脳室内、鼻腔内、室内、舌下、眼内、直腸内、局所(例えば経皮)、口腔および吸入〕が挙げられる。通常は皮下または筋肉内投与されるデポー注射剤を使用して、限定された時間に渡り化合物Iを放出させることも可能である。
本発明は、1つ以上の活性治療薬(例えば化学療法薬)または他の予防もしくは治療方法(例えば放射線)と組み合わせた化合物Iの使用に関する。そのような併用療法では、様々な活性薬剤がしばしば異なる相補的な作用機序を有しうる。そのような併用療法は、1つ以上の薬剤の投与量の減量を可能にし、1つ以上の薬剤に関連した有害事象を低減または排除することにより、特に有利であることができる。更に、そのような併用療法は、根本的な疾病、障害または状態に対する相乗的な治療効果または予防効果を有することができる。
〔キット〕
〔実験〕
材料と方法
〔実施例〕
実施例1:3-[2-アミノ-6-(1-{[6-(2-ヒドロキシプロパン-2-イル)ピリジン-2-イル]メチル}-1H-1,2,3-トリアゾール-4-イル)ピリジン-4-イル]-2-メチルベンゾニトリルの合成
実施例2:単回投与漸増(SAD)試験および反復投与漸増(MAD)試験
〔試験計画〕
各参加者のおよび/または各コホート内での用量漸増の中止は、以下の特定のシナリオのいずれかが、治験薬との因果関係の合理的な可能性とともに発生する場合に考慮される。
・1名以上の参加者が重篤な有害事象(SAE)を報告した場合、または臨床的に重要である検査値(ラボ)を含む重篤なAEを経験した場合。
・さらに、スポンサーと治験責任者は、個々の被験者の単回SAEの観察および/または所定用量のコホートの傾向と交差用量コホートの傾向の観察を含むがこれらに限定されない、上記に定義されていない根拠で用量漸増を中止することを決定できる。
・スポンサーおよび治験責任者の裁量により、これ以上の投与を中止すべきであることを示唆するその他の所見が認められる場合。
食事の影響
試験集団の選択-選択基準
1. 年齢18歳以上55歳以下の男性または女性の参加者。
2. インフォームドコンセントに署名する意思と能力があること。
3. 体格指数(BMI)が19 kg/m2以上30 kg/m2以下であること。
4. 試験前(pre-study)の病歴、身体検査、バイタルサイン、全神経学的検査および12誘導ECGによって健康と判定されること。
5. スクリーニング時のB型肝炎表面抗原(HBsAg)、抗C型肝炎ウイルス(HCV)並びにヒト免疫不全ウイルス(HIV)-1およびHIV-2抗体の検査結果が陰性であること。
6. 血液と尿のすべての臨床検査結果が、正常範囲内であるか、またはスクリーニング時および入院時にPIによって判定した時に臨床的に関連のある逸脱を示さないこと。
7. 非喫煙者またはスクリーニング来院の3か月より前に禁煙した元喫煙者。
8. 妊娠の可能性のある女性、妊娠の可能性のない女性、および閉経後の女性を含める場合:スクリーニング時、女性は妊娠しておらず、授乳していないか、または卵胞刺激ホルモン検査によって確認された、妊娠可能性がないこと(外科的に滅菌されているか、受胎することが生理的に不可能であるか、または閉経後少なくとも1年[連続した12か月の無月経期間]であること);非妊娠は、スクリーニングで行われる血清妊娠検査、および各入院時の尿または血清妊娠検査により、すべての女性について確認されるだろう。
9. 出産の可能性のある女性の参加者は、男性の性的パートナーと一緒に、スクリーニングから経過観察(フォローアップ)の来院後90日目まで、適切な避妊を使用することに同意する必要がある。ここで適切な避妊とは、ホルモン避妊薬または子宮内避妊器具を、次の避妊方法の少なくとも1つと組み合わせて使用することであると定義される:横隔膜もしくは子宮頸部キャップまたはコンドーム。また、参加者の生活スタイルに応じた完全な禁酒も認められる。
10. 男性の参加者は、外科的に滅菌されていない場合、適切な避妊を使用することに同意し、臨床研究センターへの(最初の)入院から経過観察(フォローアップ)来院後90日目までは、精子を寄付してはならない。男性の参加者(およびその女性パートナー)に対する適切な避妊とは、ホルモン避妊薬または子宮内避妊具を、次の避妊方法の少なくとも1つと組み合わせて使用することであると定義される:横隔膜もしくは子宮頸部キャップ、またはコンドーム。また、参加者の生活スタイルに応じた完全な禁酒も認められる。
11. すべての処方薬は、臨床研究センターへの(それぞれの)入院の少なくとも30日前に中止されていなければならない。ホルモン避妊薬は例外であり、試験期間の間使用される場合がある。
12. すべての市販薬、ビタミン剤およびその他の栄養補助食品(サプリメント)、またはハーブ薬(例えば、セントジョンズワート)は、臨床研究センターへの入院の少なくとも14日前に服用を停止していなければならない。パラセタモールは例外であり、臨床研究センターへの入院まで許可される。
13. アルコール、メチルキサンチン含有飲料または食品(コーヒー、紅茶、コーラ、チョコレート、エネルギードリンク)、およびグレープフルーツ(ジュース)とタバコ製品は、それぞれの入院の48時間前から入院中および滞在中は控えなければならない。
試験集団の選択-除外基準
1. 現試験への以前の参加を有する者。
2. 関連する薬物および/または食物アレルギーの既往歴がある者。
3. アルコール乱用または薬物中毒の既往歴(大麻製品などのソフトドラッグを含む)を有する者。
4. スクリーニング時および臨床研究センターへの(各)入院時の薬物およびアルコールスクリーニング(オピエート、メタドン、コカイン、アンフェタミン(エクスタシー(MDMA)を含む)、カンナビノイド、バルビツール酸塩、ベンゾジアゼピン、γ-ヒドロキシ酪酸、三環系抗うつ薬およびアルコール)が陽性である者。
5. 1週間あたり24単位を超えるアルコールの平均摂取量(1単位のアルコールとは、ビール約250 mL、ワイン100 mL、またはスピリッツ35 mLに相当する)を有する者。
6. 現試験での(最初の)薬物投与前の60日以内に薬物試験への参加経験を有する者。現試験での(最初の)薬物投与前の12か月間に4つ以上の他の薬物試験への参加を有する者。
7. (最初の)薬剤投与前の60日以内に100 mLを超える血液の寄付または喪失がある者。現研究での(最初の)薬物投与前の10か月に1.5 L以上の血液(男性参加者用)/1.0 L以上の血液(女性参加者用)の寄付または喪失がある者。
8. 食品医薬品局(FDA)の朝食を消費したくない者(FEパートに適用)。
9. 静脈が採血に適さない者。
10. 呼吸器、胃腸、腎臓、肝臓、血液、リンパ、神経、心血管、精神医学、筋骨格、泌尿生殖器、免疫、皮膚、内分泌、結合組織の疾患または障害の、臨床的に関連する既往歴または存在を有する参加者。
11. スクリーニング時または入院時に重篤な感染症または既知の炎症過程を有する者。
試験における投薬のタイミング
摂食条件の下での投薬
検査中の食事
・目玉焼き 2個(15 gのバター/マーガリン入)(約100 g)
・ベーコンの一片(40 g)*
・フライドポテト(115 g)
・15 gのマーガリンを塗った(小麦の)(トーストした)パン2片、および
・高脂肪牛乳 グラス1杯(240 mL)
* ベジタリアンの場合、ベーコンの代わりにブリーチーズ60+を使用可能。
評価スケジュールを、表1、表2、および表3に示す。
表1注釈:
1. 全身体検査はスクリーニング時に実施する(身長と体重はスクリーニング時にのみ)。最新の身体検査は-1日目と経過観察時に実施する。
2. 神経学的検査は、臨床評価と身体動揺検査から成る。全神経学的検査は、スクリーニング時、-1日目、および経過観察時に実施する。簡略試験は臨床検査(標的を絞った)から成る。身体動揺検査および徴候特異的検査は他の全日に実施する。
3. 気分と覚醒(Mood and Alertness)のBond & Lader VAS;DSST; DSSTを訓練し、-1日目に初回試験、個体群1~4については投与後2~4時間の時間窓において1日目および2日目に、そして個体群5については投与後2~4時間の時間窓において1日目にDSST。
4. EEG は75 mgより高用量(即ち個体群3およびより高用量)を受けた参加者についてスクリーニング時に実施し、そして試験中に何らかの神経学的有害事象が臨床的に示された場合に実施する。
5. バイタルサインは血圧、脈拍、体重および呼吸数から成る。臥位および立位でのバイタルサインをスクリーニング時および-1日目に3回実施する。個体群1~4については、単独の臥位および立位でのバイタルサインを1日目の投与前と、投与後 1, 2, 3, 4, 6, 8, 12および 48 時間目に収集する。個体群5(2倍用量)については、バイタルを1日目の投与前と、1回目投与後1, 2, 3, 4, 5, 6, 8, 24 および48時間目、並びに2回目投与前と投与後1, 2および 3時間目に収集する。バイタルは全ての群で経過観察時にも収集される。
6. ECG は全ての時点で3回反復で取得される。参加者は3回反復ECGの各々の前の少なくとも15分間、仰臥位安静にされる。ECGは、PKサンプリングが同時点である場合に各PKサンプリングの前に収得される。ECGはスクリーニング時並びに入院前-1日目、入院後2, 4, および8時間後に収得する。ECGは、個体群1~4については投与前と投与後0.5, 1, 2, 3, 4, 6, 8, 12, 24および 48 時間目(および臨床的徴候があれば他の日も)に収得する。個体群5(2倍用量)については、ECGは1日目の投与前、1回目投与後0.5, 1, 2, 3, 4, 5, 6, 8, 24 および48時間目、並びに2回目投与前と投与後0.5, 1, 2および 3 時間後に収得する。ECG は全ての個体群について経過観察時に収得する。
7 .尿は1日目の投与前、並びに投与後0~12、12~24および24~48時間目に累積的に、PK用と代謝物特徴付け用に採取する。全量を採尿する。細部については研究マニュアルを参照のこと。個体群5については、時点は初回投与時を基準とする。
8. 全ての女性参加者はスクリーニング時(血清)および -1日目(尿または血清)に妊娠について検査される。
9. 更年期後の女性参加者は、最終月経期後12か月未満の場合に限られる。
10. 投与前。
11. 血液は、個体群1~4については投与前と投与後0.5, 1, 2, 3, 4, 6, 8, 12, 24および 48時間後にPK用に採集される。個体群5については(投与12時間毎)、PK用の血液は1日目の投与前と、1回目投与後0.5, 1, 2, 3, 4, 5, 6, 8, 24および 48時間後、並びに2回目投与前と投与後0.5, 1, 2および 3 時間後に採集される。
12. 血液は、1日目の投与前と、投与後2時間および24時間後にPD用に採集される。個体群5については、時点は初回投与時を基準とする。
13. 1日目の投与30分前から投与24時間後までテレメトリーを実施する。個体群5については、時点は初回投与時を基準とする。
14. 経過観察を通してインフォームドコンセントから有害事象が収得される。
15. 退院後または早期中断後4~7日間実施される。
DSST: 数字符号置換検査; ECG: 心電図; EEG: 脳波図; FSH: 濾胞刺激ホルモン; PD: 薬力学; PK: 薬物動態学; VAS: 視覚的アナログ尺度
表2注釈:
1. 全身体検査はスクリーニング時に実施する(身長と体重はスクリーニング時にのみ)。最新の身体検査は1,2および3日目と経過観察時に実施する。
2. 神経学的検査は、臨床評価と身体動揺検査から成る。全神経学的検査は、スクリーニング時、-1日目、および経過観察時に実施する。簡略試験は臨床検査(標的を絞った)から成る。身体動揺検査および徴候特異的検査は他の全日に実施する。
3. 気分と覚醒のBond & Lader VAS;DSST; DSSTを訓練し、-1日目に初回試験、個体群1~4については投与後2~4時間の時間窓において1,2,3,4および5日目に、そして個体群5については朝投与後2~4時間の時間窓において1日目にDSST試験。
4. EEG は75 mgより高用量(即ち個体群3およびそれより高用量)を受けた参加者についてスクリーニング時に実施し、そして試験中に何らかの神経学的有害事象が臨床的に示された場合に実施する。
5. バイタルサインは血圧、脈拍、体重および呼吸数から成る。臥位および立位でのバイタルサインはスクリーニング時と-1日(前日)に3回実施する。個体群1~4については、単回の臥位および立位でのバイタルサインを1日目~4日目の投与前と、投与後 1, 2, 3, 4, 6, 8, 12時間目に収集する。個体群5(12時間ごと投与)については、バイタルサインを1~4日目の投与前と、初回投与後1, 2, 3, 4, 6, 8時間目、並びに2回目投与前と投与後1, 2および 3時間後に収集する。5日目に、全ての群で退院前と経過観察時にもバイタルサインが収集される。
6. ECG は全ての時点で3回反復で収得される。参加者は各々の3回反復ECG前に少なくとも15分間、仰臥位安静にされる。ECG は、PKサンプリングが同時点である場合に各PKサンプリングの前に収得される。ECGはスクリーニング時、および入院-1日目(前日)に収得する。ECGは、個体群1~4については1日目と4日目の投与前、並びに投与後0.5, 1, 2, 3, 4, 6, 8, および12 時間目におよび2日目と3日目は投与前のみ収得する。個体群5(12時間ごと投与)については、ECGは1日目と4日目の投与前、初回投与後0.5, 1, 2, 3, 4, 6, 8時間目、並びに2回目の投与前と投与後 1, 2および 3 時間後に収得する。5日目に、全ての個体群について退院前と経過観察時にECGを収得する。全ての個体群は5日目の午前8時(± 15分)および経過観察時にECGを実施する。
7. 全ての女性参加者はスクリーニング時(血清)および-1日目(尿または血清)に妊娠について検査する。
8. 更年期後女性参加者は、最終月経期後12か月未満の場合に限られる。
9. 投与前。
10. 血液は、個体群1~4については1日目と4日目の投与前と投与後0.5, 1, 2, 3, 4, 6, 8および12間後、並びに2日目および3日目の投与前にPK用に採集される。個体群5については(投与12時間毎)、PK用の血液は1日目と4日目の投与前と、1回目投与後0.5, 1, 2, 3, 4, 6, 8時間後、並びに2回目投与前と投与後1, 2および 3 時間後に採集される。個体群5については、2日目と3日目の朝晩の投与前。全ての個体群は5日目の午前8時(8:00 am)(±15分)にPK用に採血される。
11. 血液は、1日目の投与前と、4日目の投与前と投与後2時間および24時間後にPD用に採集される。個体群5については、時点は初回投与時を基準とする。
12. 1日目の投与30分前から投与24時間後までテレメトリーを実施する。個体群5については、時点は初回投与時を基準とする。
13. 経過観察を通してインフォームドコンセントから有害事象が収得される。
14. 退院後または早期中断後に4~7日間実施される。
DSST: 数字符号置換検査; ECG: 心電図; EEG: 脳波図; FSH: 濾胞刺激ホルモン; PD: 薬力学; PK: 薬物動態学; VAS: 視覚的アナログ尺度
表3注釈:
1. 全身体検査はスクリーニング時に実施する(身長と体重はスクリーニング時にのみ)。最新の身体検査は全ての在宅の日と経過観察時に実施する。
2. 神経学的検査は、臨床評価と身体動揺検査から成る。全神経学的検査は、スクリーニング時、-1日目および6日目並びに経過観察時に実施する。簡略試験は臨床検査(標的を絞った)から成る。身体動揺検査および徴候特異的検査は他の全日に実施する。
3. 気分と覚醒のBond & Lader VAS;DSST; DSSTを訓練し、-1日目と6日目に初回試験、1,2,7および8日目に投与後2~4時間の時間窓においてDSST試験。
4. ECG は75 mgより高用量(即ち個体群3およびそれより高用量)を受けている参加者についてスクリーニングを実施する。FEパートの被験者は、ベースラインのEEGを有し、そして試験の間に何らかの神経学的有害事象が臨床的に示された場合にEEGを実施する。
5. バイタルサインは血圧、脈拍、体重および呼吸数から成る。臥位および立位でのバイタルサインはスクリーニング時と、-1日目および6日目に3回実施する。単回の臥位および立位でのバイタルサインは、1日目と7日目の投与前と投与後 1, 2, 3, 4, 6, 8, 12, 24および48時間目、並びに経過観察時に収集する。
6. ECG は全ての時点で3回反復で収得される。参加者は各3回のECG前に少なくとも15分間、仰臥位にされる。ECG は、PKサンプリングが同時点である場合に各PKサンプリングの前に収得される。ECGはスクリーニング時、および1日目および6日目の入院時、並びに入院後2,4および6時間に収得する。ECGは、1日目と7日目の最終投与後0.5, 1, 2, 3, 4, 6, 8, 12, 24および48 時間目(臨床的徴候が指摘される場合には他の日)並びに経過観察時に収得する。
7. 全ての女性参加者はスクリーニング時(血清)および-1日目と6日目(尿または血清)に妊娠について検査する。
8. 更年期後女性参加者は、最終月経期後12か月未満の場合に限られる。
9. 投与前。
10. 血液は、1日目と7日目の投与前並びに投与後0.5, 1, 2, 3, 4, 6, 8, 12, 24および48間後に、PK用に採集される。
11. 1日目と7日目の投与30分前から投与24時間後までテレメトリーを実施する。
12. 経過観察を通してインフォームドコンセントから有害事象が収得される。
13. 退院後または早期中断後に4~7日間実施される。
DSST: 数字符号置換検査; ECG: 心電図; EEG: 脳波図; FSH: 濾胞刺激ホルモン; PD: 薬力学; PK: 薬物動態学; VAS: 視覚的アナログ尺度
採血と採尿
薬力学的測定
安全性と耐容性範囲の測定
SADコホートのPK要約
実施例3:進行性悪性腫瘍を有する参加者における免疫療法の組み合わせの安全性と耐容性を評価するための第I相試験。
選択基準
1. 年齢18歳以上の男性または女性の参加者。
2. 代替療法もしくは治癒療法が1つも存在しないか、または参加者と治療を行う医師によって標準療法が適切と思われない(その根拠は医療記録中に明記されなければならない)、進行すると転移性、進行性または再発性となる、病理学的に確かめられた非小細胞肺癌、頭頸部の扁平上皮癌、腎細胞癌、乳癌、結腸直腸癌、黒色腫、膀胱癌、卵巣癌、子宮内膜癌、メルケル細胞癌、または胃食道癌を有する者。
3. RECIST v1.1に従って少なくとも1箇所の測定可能な病変を有すること。
4. ECOG(米国の腫瘍学団体)パフォーマンスステータスが0または1のスコアであること。
5. 治癒可能性のある有用な療法または介入を含む、標準治療を受けていること。
6. 保管可能な(archival)組織標本が入手でき、かつ6か月齢以下であること;もしそうでなければ、腫瘍病変の新たな生検標本を取得すること。
7. 適切な臓器および骨髄機能を有すること。
除外基準
1. 化合物Iの投与開始から4週間(28日)以内に感染性疾患(例えばインフルエンザ、水痘)に対する生ワクチンを受けた者。
2. 化合物Iの投与が有害(例えば間質性肺疾患、抗生物質を必要とする活動性感染、未解決の症状による最近の入院歴)になるかまたは毒性検査もしくはAEの解釈を妨害する基礎疾患、または、免疫抑制薬の使用または全身性もしくは吸収性局所コルチコステロイドの免疫抑制量の使用を必要とする同時病状を有する者。
3. 試験の必要条件と協働して干渉するであろう既往の精神医学的または薬物乱用障害を有する者。
4. 化合物Iの最終投与後90日目から、スクリーニング前またはスクリーニング来院時から開始する本試験の計画された期間の間に、妊娠中もしくは授乳中であるか、または妊娠する予定もしくは父親になる予定である者。
5. 白斑または消散した小児ぜん息/アトピーを除き、過去2年間に全身治療を必要とするいずれかの活動性自己免疫疾患または自己免疫疾患の確認された既往歴を有する者。気管支拡張薬(例えばアルブテロール)の不連続使用を必要とするぜん息患者は、本試験から除外されない。
6. 見かけ上治癒している局所的に治療可能な癌、例えば基底細胞もしくは扁平脂肪皮膚癌、表在性膀胱癌、または子宮頸癌、乳癌もしくは前立腺癌のin situ癌腫を除き、前年に活動性の既往悪性腫瘍を有する者。
7. 1日目前の2週間以内に事前の化学療法、ターゲット小分子療法、または放射線療法を受けたことがあるか、あるいはグレード2以下の脱毛症またはグレード2以下のニューロパチーを除き、前に投与した薬剤によるAEから回復(すなわちグレード1以下またはベースライン)していない者。
8. 化合物Iの投与前28日以内に別の治験薬(いずれかの適応症で販売されていない薬物)を使用した者。
有効性評価
安全性評価
予備結果
Claims (14)
- アデノシンA2A受容体(A2AR)により少なくとも部分的に、アデノシンA2B受容体(A2BR)により少なくとも部分的に、または、アデノシンA2A受容体(A2AR)およびアデノシンA2B受容体(A2BR)の両受容体により少なくとも部分的に媒介される、疾患、障害または状態の治療方法における使用のための、下式
を有する化合物I、またはその薬学的に許容される塩を含む組成物であって、該方法は、1~36か月の期間に渡り、該化合物I、またはその薬学的に許容される塩の約75mg、約100mg、または、約150mgの総1日量を、上記治療が必要な対象に経口投与することを含み、該疾患、障害または状態が、癌である、組成物。 - 前記総1日量が、1日あたり約75mgである、請求項1に記載の組成物。
- 前記総1日量が、1日あたり約150mgである、請求項1に記載の組成物。
- 前記化合物Iが1日1回投与される、請求項1~3のいずれか一項に記載の組成物。
- 前記化合物Iが1日2回投与される、請求項1~3のいずれか一項に記載の組成物。
- 前記癌が、前立腺癌、結腸癌、直腸癌、膵臓癌、子宮頸癌、胃癌、子宮内膜癌、脳腫瘍、肝臓癌、膀胱癌、卵巣癌、精巣癌、頭部癌、頸部癌、皮膚癌、中皮層癌、白血球癌、食道癌、乳癌、筋肉癌、結合組織癌、肺癌、副腎癌、甲状腺癌、腎臓癌または骨癌であるか;あるいは膠芽腫、中皮腫、腎細胞癌、胃癌、肉腫、絨毛癌、皮膚基底細胞癌、または精巣セミノーマである、請求項1に記載の組成物。
- 前記癌が、膵臓癌、非小細胞肺癌、結腸直腸癌、頭頸部扁平細胞癌、卵巣癌、トリプルネガティブ型乳癌、腎細胞癌、前立腺癌および胃食道癌からなる群より選択される、請求項1に記載の組成物。
- 対象において癌を治療する方法における使用のための、下式
を有する化合物Iまたはその薬学的に許容される塩を含む組成物であって、該方法は、1~36か月の期間に渡り、化合物Iまたはその薬学的に許容される塩の約75mg、約100mg、または、約150mgの総1日量と、少なくとも1つの追加の治療薬とを、前記対象に経口投与することを含む、組成物。 - 前記少なくとも1つの追加の治療薬が、化学療法薬、放射線、免疫および/もしくは炎症調節薬、ならびに/または免疫チェックポイント阻害薬である、請求項8に記載の組成物。
- 前記少なくとも1つの追加の治療薬が、PD1、PDL1、TIGITまたはCTLA4の少なくとも1つの活性を遮断する免疫チェックポイント阻害薬である、請求項8に記載の組成物。
- 前記少なくとも1つの追加の治療薬が、化学療法薬を更に含む、請求項10に記載の組成物。
- 前記化学療法薬がオキサリプラチン、シスプラチン、カルボプラチン、パクリタキセル、ドセタキセル、またはドキソルビシンである、請求項11に記載の組成物。
- 前記少なくとも1つの追加の治療薬がオキサリプラチン、シスプラチン、カルボプラチン、ドセタキセル、パクリタキセル、およびドキソルビシンから選択される化学療法薬である、請求項8に記載の組成物。
- 前記癌が、膵臓癌、非小細胞肺癌、結腸直腸癌、頭頸部扁平細胞癌、卵巣癌、トリプルネガティブ型乳癌、腎細胞癌、前立腺癌、食道癌および胃食道癌からなる群より選択される、請求項8に記載の組成物。
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EP3755333A4 (en) | 2021-11-17 |
TW202000200A (zh) | 2020-01-01 |
CN111818923A (zh) | 2020-10-23 |
JP2023171662A (ja) | 2023-12-01 |
JP2021513965A (ja) | 2021-06-03 |
US20230338377A1 (en) | 2023-10-26 |
WO2019161054A1 (en) | 2019-08-22 |
US20200405718A1 (en) | 2020-12-31 |
AU2019222747A1 (en) | 2020-10-08 |
CA3090922A1 (en) | 2019-08-22 |
KR20200121337A (ko) | 2020-10-23 |
US11478479B2 (en) | 2022-10-25 |
EP3755333A1 (en) | 2020-12-30 |
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