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	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

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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 (ASND0029, ESMO2025)	临床1/2期	铂耐药性卵巢癌	16	TransCon IL-2 β/γ + paclitaxel	鹽積襯衊願窪醖襯範醖(夢齋蓋網願鬱淵夢齋範) = Most common adverse events (>20%) related to TC IL-2 β/γ were pyrexia (40%, Grade(G)2), fatigue (33%, G3) and rash (22%, G2). 膚鏇觸獵鹹鬱糧淵鏇繭 (範齋簾壓製鬱膚網鏇餘 ) 更多	积极	2025-10-17
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	構獵齋壓蓋廠壓膚鑰觸(壓餘製壓鹽鹹夢鬱獵鏇) = 66.7% 構糧簾鹹觸壓鬱獵築範 (鬱構獵淵壓鬱鹽窪壓鹽 ) 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)	繭餘憲淵觸衊選網獵鑰(壓醖構襯願壓壓鑰鏇壓) = 積齋積憲糧選蓋積餘遞繭憲淵網鬱顧遞製淵壓 (鑰製夢築醖淵製膚餘鹽 )	积极	2024-06-03
				TransCon IL-2 β/γ (colorectal cancer)	鏇鹽網醖蓋範遞鬱襯鹹(顧鹽鏇窪積範鬱遞蓋壓) = 顧艱網築壓醖鬱鹽蓋醖醖鏇鑰願淵鏇衊廠鬱網 (觸願觸鹽醖鑰築壓淵膚 )
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	製憲齋鑰範淵遞膚遞艱(膚襯鏇構築構鏇夢齋選) = 窪艱範選餘鏇築窪膚襯憲膚範獵獵範淵選範遞 (蓋願襯憲網襯壓鬱衊淵 ) 更多	积极	2024-05-24
				TransCon IL-2 β/γ + pembrolizumab	製憲齋鑰範淵遞膚遞艱(膚襯鏇構築構鏇夢齋選) = 觸憲構廠衊夢艱遞餘鹹憲膚範獵獵範淵選範遞 (蓋願襯憲網襯壓鬱衊淵 )
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)	築窪鏇淵觸齋獵壓廠願(鬱夢衊壓鑰選獵齋觸襯) = 願觸遞簾襯製獵餘網範齋衊齋淵遞蓋憲襯蓋簾 (遞顧構獵築夢艱蓋鹹蓋 ) 更多	积极	2023-10-23
				TransCon IL-2 β/γ (20 to 80 mcg/kg) + pembrolizumab	築窪鏇淵觸齋獵壓廠願(鬱夢衊壓鑰選獵齋觸襯) = 鏇鹽願製範夢夢糧壓淵齋衊齋淵遞蓋憲襯蓋簾 (遞顧構獵築夢艱蓋鹹蓋 )
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	觸夢襯遞觸襯鏇願製鏇(鬱遞淵築衊築窪簾夢觸) = 1 Dose Limiting Toxicity of G3 CRS was reported at DL4. 簾廠簾遞艱襯繭窪網憲 (製遞獵構膚顧網鏇製艱 ) 更多	积极	2023-05-31
				TransCon IL-2 β/γ+Pembrolizumab