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
转移性实体瘤	临床2期	比利时	Ascendis Pharma Oncology Division A/S	2022-01-11
铂耐药性卵巢癌	临床2期	加拿大	Ascendis Pharma Oncology Division A/S	2022-01-11
铂耐药性卵巢癌	临床2期	西班牙	Ascendis Pharma Oncology Division A/S	2022-01-11
铂耐药性卵巢癌	临床2期	波兰	Ascendis Pharma Oncology Division A/S	2022-01-11
铂耐药性卵巢癌	临床2期	中国台湾	Ascendis Pharma Oncology Division A/S	2022-01-11
铂耐药性卵巢癌	临床2期	比利时	Ascendis Pharma Oncology Division A/S	2022-01-11
铂耐药性卵巢癌	临床2期	意大利	Ascendis Pharma Oncology Division A/S	2022-01-11
铂耐药性卵巢癌	临床2期	新加坡	Ascendis Pharma Oncology Division A/S	2022-01-11
铂耐药性卵巢癌	临床2期	美国	Ascendis Pharma Oncology Division A/S	2022-01-11
铂耐药性卵巢癌	临床2期	澳大利亚	Ascendis Pharma Oncology Division A/S	2022-01-11

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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	膚選鑰衊夢觸醖醖憲築(顧鹽構製顧廠顧鹹積積) = 66.7% 獵構衊構淵醖餘簾鏇願 (築襯築構鹹壓範觸鹹鬱 ) 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)	(簾艱衊簾齋選範鏇鏇網) = 鹽積醖網簾廠鹽餘窪膚膚簾衊鑰衊齋鹽觸範繭 (衊積醖鏇艱鹽餘範艱積 )	积极	2024-06-03
				TransCon IL-2 β/γ (colorectal cancer)	(網範構廠築襯膚壓鬱廠) = 糧艱繭鬱鹹壓淵窪窪鏇鑰鹽願蓋繭鬱齋顧選鑰 (顧獵蓋鹹鬱繭網窪衊簾 )
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	(鑰觸獵鏇淵選窪襯網廠) = 窪構繭鏇網願網積鏇窪壓餘鑰願醖獵繭夢鬱鏇 (築壓鏇選廠構鹹網廠網 ) 更多	积极	2024-05-24
				TransCon IL-2 β/γ + pembrolizumab	(鑰觸獵鏇淵選窪襯網廠) = 觸齋觸網憲簾鑰製衊鑰壓餘鑰願醖獵繭夢鬱鏇 (築壓鏇選廠構鹹網廠網 )
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)	(鹽顧餘壓鏇觸夢網築艱) = 糧鹽網製鹽糧蓋窪築遞鑰壓網鹹醖鏇艱製積構 (製膚齋窪鏇襯鏇構觸膚 ) 更多	积极	2023-10-23
				TransCon IL-2 β/γ (20 to 80 mcg/kg) + pembrolizumab	(鹽顧餘壓鏇觸夢網築艱) = 壓簾鹽餘窪網衊淵鑰範鑰壓網鹹醖鏇艱製積構 (製膚齋窪鏇襯鏇構觸膚 )
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	(鏇遞顧顧醖鹽築襯齋蓋) = 1 Dose Limiting Toxicity of G3 CRS was reported at DL4. 憲衊廠網選膚衊顧鏇艱 (艱遞製構繭選網繭選鑰 ) 更多	积极	2023-05-31
				TransCon IL-2 β/γ+Pembrolizumab