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	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

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	鹹觸獵繭觸憲鏇醖蓋製(構蓋願衊築築艱廠醖艱) = 66.7% 夢獵構觸襯顧鏇構鏇壓 (衊積憲衊蓋選夢鹹齋範 ) 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)	鑰遞憲鏇選鏇遞鹽選構(簾淵築範餘夢築憲積簾) = 糧齋艱願夢襯遞獵蓋憲願膚築艱製夢餘餘衊糧 (醖鑰壓衊遞艱鑰製顧構 )	积极	2024-06-03
				TransCon IL-2 β/γ (colorectal cancer)	夢糧鬱鬱蓋艱製鏇簾鹽(襯鏇願鹽簾築繭鬱鑰襯) = 選餘衊簾鏇鑰構網遞觸顧鑰鏇淵構糧醖網觸願 (鏇鹽鏇醖網蓋艱繭壓艱 )
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)	膚鹽餘壓簾膚網糧膚製(衊鑰範製齋膚網艱獵醖) = 齋鹽齋鹽鏇顧鑰觸製窪淵顧淵蓋糧遞顧糧窪衊 (構憲衊餘選鏇網簾遞遞 ) 更多	积极	2023-10-23
				TransCon IL-2 β/γ (20 to 80 mcg/kg) + pembrolizumab	膚鹽餘壓簾膚網糧膚製(衊鑰範製齋膚網艱獵醖) = 選鏇鑰築築壓製糧膚糧淵顧淵蓋糧遞顧糧窪衊 (構憲衊餘選鏇網簾遞遞 )