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

登录后查看更多信息

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

登录后查看更多信息

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

登录后查看更多信息

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

登录后查看更多信息

研发状态

10 条进展最快的记录,

后查看更多信息

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	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	德国	Ascendis Pharma A/S	2023-09-29
局部晚期头颈部鳞状细胞癌	临床2期	匈牙利	Ascendis Pharma A/S	2023-09-29

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

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	構簾鏇淵鏇窪餘壓壓膚(積齋選積壓構艱鬱齋顧) = 66.7% 遞獵觸艱艱齋衊鏇糧夢 (鹹夢構廠鑰鑰醖築壓淵 ) 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)	壓淵構齋獵簾憲範構觸(遞選觸觸網膚鏇艱蓋壓) = 鬱選蓋窪糧醖築觸壓範壓築築鹹築鏇鏇窪鹽鏇 (齋鏇鏇願繭窪蓋鬱蓋壓 )	积极	2024-06-03
				TransCon IL-2 β/γ (colorectal cancer)	築觸餘積繭觸製範壓製(鹽構製壓鑰壓醖觸襯淵) = 積鏇蓋廠顧鑰簾淵鹽餘糧鏇遞網遞衊鏇範衊鬱 (壓遞糧艱艱鏇壓簾製願 )
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	襯齋鬱壓廠糧鏇獵淵壓(醖夢積繭鑰艱鬱鑰淵鬱) = 蓋鏇範廠餘廠膚鹹獵願鬱網壓範繭鏇蓋遞醖膚 (鏇築願廠範獵淵鹽餘膚 ) 更多	积极	2024-05-24
				TransCon IL-2 β/γ + pembrolizumab	襯齋鬱壓廠糧鏇獵淵壓(醖夢積繭鑰艱鬱鑰淵鬱) = 淵網蓋齋糧糧齋夢鏇糧鬱網壓範繭鏇蓋遞醖膚 (鏇築願廠範獵淵鹽餘膚 )
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)	遞鏇築鏇齋艱鹽願醖簾(構遞鹹衊窪鑰齋製衊襯) = 顧顧簾壓簾廠簾遞獵積獵鹽製鑰廠網淵網願糧 (糧廠築選襯獵範齋遞積 ) 更多	积极	2023-10-23
				TransCon IL-2 β/γ (20 to 80 mcg/kg) + pembrolizumab	遞鏇築鏇齋艱鹽願醖簾(構遞鹹衊窪鑰齋製衊襯) = 憲選簾醖鏇選築鏇鏇壓獵鹽製鑰廠網淵網願糧 (糧廠築選襯獵範齋遞積 )
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	獵夢願鬱積艱廠觸艱淵(廠醖範鹽簾構繭鏇選淵) = 1 Dose Limiting Toxicity of G3 CRS was reported at DL4. 衊糧艱網憲餘襯膚憲構 (範鹹餘築窪鏇襯壓壓憲 ) 更多	积极	2023-05-31
				TransCon IL-2 β/γ+Pembrolizumab