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	餘願繭鏇願廠積夢築醖(襯簾顧鹽鑰窪鹽繭構壓) = 66.7% 餘鏇醖遞餘淵憲醖襯淵 (艱製鹽淵艱構範餘憲糧 ) 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)	積鏇艱獵衊範鬱膚範構(憲簾衊壓醖鑰廠鏇簾齋) = 醖願鑰夢糧鹽艱憲衊範衊膚淵選鏇獵顧願淵壓 (醖築觸顧鏇窪淵鑰鹹糧 )	积极	2024-06-03
				TransCon IL-2 β/γ (colorectal cancer)	夢範憲積構壓獵醖鏇積(鏇鑰選蓋顧製廠壓夢醖) = 遞齋鬱鬱艱願選壓夢構憲衊衊鹹淵蓋壓鹹簾衊 (憲膚範憲積憲鏇選艱廠 )
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	鹹糧構築蓋蓋蓋遞膚壓(廠淵鏇網選鹹窪鹽構齋) = 艱鏇膚夢憲製顧餘遞衊艱遞糧廠鹹艱鏇窪構遞 (淵構艱壓衊鹽選壓衊顧 ) 更多	积极	2024-05-24
				TransCon IL-2 β/γ + pembrolizumab	鹹糧構築蓋蓋蓋遞膚壓(廠淵鏇網選鹹窪鹽構齋) = 構襯艱獵繭鑰構淵鏇網艱遞糧廠鹹艱鏇窪構遞 (淵構艱壓衊鹽選壓衊顧 )
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)	築淵蓋製壓廠餘齋膚繭(積糧網齋獵選壓鹽衊網) = 夢積齋蓋鑰願遞築襯鬱襯鬱遞繭構淵鬱壓簾餘 (網網願衊齋蓋艱鬱憲憲 ) 更多	积极	2023-10-23
				TransCon IL-2 β/γ (20 to 80 mcg/kg) + pembrolizumab	築淵蓋製壓廠餘齋膚繭(積糧網齋獵選壓鹽衊網) = 醖窪糧醖鏇簾獵繭淵製襯鬱遞繭構淵鬱壓簾餘 (網網願衊齋蓋艱鬱憲憲 )
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	膚窪膚製繭襯積獵觸艱(淵憲夢繭網蓋齋夢鏇蓋) = 1 Dose Limiting Toxicity of G3 CRS was reported at DL4. 遞願獵遞願築鬱壓築範 (顧獵廠網構齋範築艱簾 ) 更多	积极	2023-05-31
				TransCon IL-2 β/γ+Pembrolizumab