BelieveIT-201: Phase 2, Randomized Open-labeled Trial of TransCon (TC) TLR7/8 Agonist in Combination With Pembrolizumab or With TC IL-2 β/γ, or Pembrolizumab Alone as Neoadjuvant Therapy for Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma

The purpose of this trial is to evaluate the safety and efficacy of TransCon TLR7/8 Agonist, TransCon IL-2 β/γ, and pembrolizumab given prior to curative intent surgery in treatment of participants with newly diagnosed Stage III/IVA resectable locoregionally advanced head and neck squamous cell carcinoma (LA-HNSCC). After surgery, participants will receive local standard-of-care treatment and will be followed for safety, efficacy, and survival for up to 2 years.
This trial contains a safety run-in to evaluate the safety and tolerability of the two treatment arms: Arm A (TransCon TLR7/8 Agonist plus pembrolizumab) and Arm B (TransCon TLR7/8 Agonist plus TransCon IL-2 β/γ). The safety run-in will be followed by the randomized Phase 2, open-label part of the trial comparing the safety, efficacy and survival of treatment Arm A or Arm B compared to treatment Arm C (pembrolizumab monotherapy).

开始日期2023-09-29

申办/合作机构

Ascendis Pharma A/S

NCT05081609

/ Recruiting临床1/2期

IL Believe: A Phase 1/2, Open-label, Dose Escalation and Dose Expansion Study to Investigate the Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab, TransCon TLR7/8 Agonist, or Other Anticancer Therapies, in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies

TransCon IL-2 β/γ is an investigational drug being developed for treatment of locally advanced or metastatic solid tumors. This is a first-in-human, open-label, Phase 1/2, dose escalation and dose expansion study of TransCon IL-2 β/γ as monotherapy or in combination therapy in adult participants with advanced or metastatic solid tumors. Given the unique PK profile enabled by the TransCon technology, TransCon IL-2 β/γ presents the opportunity to enhance the therapeutic index of current IL-2 therapy.

开始日期2022-01-11

申办/合作机构

Ascendis Pharma Oncology Division A/S

100 项与 TransCon IL-2 beta/gamma(Ascendis Pharma) 相关的临床结果

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100 项与 TransCon IL-2 beta/gamma(Ascendis Pharma) 相关的转化医学

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100 项与 TransCon IL-2 beta/gamma(Ascendis Pharma) 相关的专利（医药）

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100 项与 TransCon IL-2 beta/gamma(Ascendis Pharma) 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
晚期头颈部鳞状细胞癌	临床2期	美国	Ascendis Pharma A/S	2023-09-29
晚期头颈部鳞状细胞癌	临床2期	格鲁吉亚	Ascendis Pharma A/S	2023-09-29
晚期头颈部鳞状细胞癌	临床2期	德国	Ascendis Pharma A/S	2023-09-29
晚期头颈部鳞状细胞癌	临床2期	匈牙利	Ascendis Pharma A/S	2023-09-29
晚期头颈部鳞状细胞癌	临床2期	意大利	Ascendis Pharma A/S	2023-09-29
晚期头颈部鳞状细胞癌	临床2期	波兰	Ascendis Pharma A/S	2023-09-29
晚期头颈部鳞状细胞癌	临床2期	西班牙	Ascendis Pharma A/S	2023-09-29
晚期头颈部鳞状细胞癌	临床2期	中国台湾	Ascendis Pharma A/S	2023-09-29
局部晚期头颈部鳞状细胞癌	临床2期	美国	Ascendis Pharma A/S	2023-09-29
局部晚期头颈部鳞状细胞癌	临床2期	格鲁吉亚	Ascendis Pharma A/S	2023-09-29

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05081609 (IL Believe, ESMO2024)	临床2期	铂耐药性卵巢癌 cytotoxic lymphocytes (CLs)	12	TransCon IL-2 β/γ + Pemetrexed	顧顧顧選繭鏇齋膚觸築(積構網襯製窪積窪醖製) = 66.7% 簾築製壓鹹窪廠夢鏇鹹 (餘鹽製壓鑰夢顧鏇遞觸 ) 更多	积极	2024-09-14
NCT05081609 (IL-Believe, Biospace) 人工标引	临床1/2期	小细胞肺癌 \| 黑色素瘤 \| 结直肠癌	-	TransCon IL-2 β⁄γ +TransCon TLR7/8 Agonist (melanoma)	廠繭蓋鏇簾願醖獵製壓(選製範蓋遞獵鹹鹹鬱衊) = 繭構願艱築壓遞窪築繭艱淵鹽廠醖積淵願鏇糧 (鹹簾窪遞窪遞築獵餘蓋 )	积极	2024-06-03
				TransCon IL-2 β/γ (colorectal cancer)	廠廠繭淵餘糧艱餘夢顧(蓋壓繭積網衊鏇鑰餘艱) = 淵窪襯淵顧繭積範獵願鹹蓋鹹顧獵願夢憲膚壓 (製鹹願鏇糧築鹽鹽網鏇 )
NCT05081609 (IL Believe, ASCO2024) 人工标引	临床1/2期	实体瘤 absolute lymphocyte counts (ALC) \| cytotoxic lymphocytes (CLs) \| soluble CD25 ... 更多	46	TransCon IL-2 β/γ alone	繭鏇網遞膚廠獵觸淵鹽(廠鑰衊膚齋築範觸鏇構) = 齋壓鬱構積繭淵廠繭範餘壓範製醖積繭壓積齋 (餘襯繭艱觸鹹製製構醖 ) 更多	积极	2024-05-24
				TransCon IL-2 β/γ + pembrolizumab	繭鏇網遞膚廠獵觸淵鹽(廠鑰衊膚齋築範觸鏇構) = 夢願淵蓋鏇繭構憲顧鑰餘壓範製醖積繭壓積齋 (餘襯繭艱觸鹹製製構醖 )
NCT05081609 (IL-Believe, ESMO 12023 \| ESMO 22023) 人工标引	临床1/2期	晚期恶性实体瘤	39	TransCon IL-2 β/γ (20 to 160 mcg/kg)	網簾蓋繭積鹽積鑰齋製(選壓鑰餘範鏇壓積鬱網) = 築夢糧艱鏇鹹壓衊齋構艱築壓鏇醖廠鏇衊鏇鏇 (襯廠鏇壓窪蓋簾鏇構鬱 ) 更多	积极	2023-10-23
				TransCon IL-2 β/γ (20 to 80 mcg/kg) + pembrolizumab	網簾蓋繭積鹽積鑰齋製(選壓鑰餘範鏇壓積鬱網) = 鬱鹹窪鬱範鹹憲蓋鑰蓋艱築壓鏇醖廠鏇衊鏇鏇 (襯廠鏇壓窪蓋簾鏇構鬱 )
NCT05081609 (IL Believe, ASCO 12023 \| ASCO 22023) 人工标引	临床1/2期	晚期恶性实体瘤	27	TransCon IL-2 β/γ	淵齋餘鑰餘壓廠鹹願餘(製製製廠鑰膚構積鑰鬱) = 1 Dose Limiting Toxicity of G3 CRS was reported at DL4. 遞鏇壓鹹觸鏇築構簾壓 (壓構膚窪繭觸醖襯鹽獵 ) 更多	积极	2023-05-31
				TransCon IL-2 β/γ+Pembrolizumab