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).

Start Date29 Sep 2023

Sponsor / Collaborator

Ascendis Pharma A/S

NCT05081609

/ RecruitingPhase 1/2

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.

Start Date11 Jan 2022

Sponsor / Collaborator

Ascendis Pharma Oncology Division A/S

100 Clinical Results associated with TransCon IL-2 beta/gamma(Ascendis Pharma)

100 Translational Medicine associated with TransCon IL-2 beta/gamma(Ascendis Pharma)

100 Patents (Medical) associated with TransCon IL-2 beta/gamma(Ascendis Pharma)

100 Deals associated with TransCon IL-2 beta/gamma(Ascendis Pharma)

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Head and Neck Squamous Cell Carcinoma	Phase 2	United States	Ascendis Pharma A/S	29 Sep 2023
Advanced Head and Neck Squamous Cell Carcinoma	Phase 2	Germany	Ascendis Pharma A/S	29 Sep 2023
Advanced Head and Neck Squamous Cell Carcinoma	Phase 2	Hungary	Ascendis Pharma A/S	29 Sep 2023
Advanced Head and Neck Squamous Cell Carcinoma	Phase 2	Italy	Ascendis Pharma A/S	29 Sep 2023
Advanced Head and Neck Squamous Cell Carcinoma	Phase 2	Poland	Ascendis Pharma A/S	29 Sep 2023
Advanced Head and Neck Squamous Cell Carcinoma	Phase 2	Spain	Ascendis Pharma A/S	29 Sep 2023
Advanced Head and Neck Squamous Cell Carcinoma	Phase 2	Taiwan Province	Ascendis Pharma A/S	29 Sep 2023
Locally Advanced Head and Neck Squamous Cell Carcinoma	Phase 2	United States	Ascendis Pharma A/S	29 Sep 2023
Locally Advanced Head and Neck Squamous Cell Carcinoma	Phase 2	Germany	Ascendis Pharma A/S	29 Sep 2023
Locally Advanced Head and Neck Squamous Cell Carcinoma	Phase 2	Hungary	Ascendis Pharma A/S	29 Sep 2023

Clinical Result

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Phase

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05081609 (ASND0029, ESMO2025)	Phase 1/2	Platinum-Resistant Ovarian Carcinoma	16	TransCon IL-2 β/γ + paclitaxel	qnvrfbwxhu(drghgwsemt) = 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). ffhhemuzym (jhewdoynte ) View more	Positive	17 Oct 2025
NCT05081609 (IL Believe, ESMO2024)	Phase 2	Platinum-Resistant Ovarian Carcinoma cytotoxic lymphocytes (CLs)	12	TransCon IL-2 β/γ + Pemetrexed	rojftnkqek(gbrhbdpblw) = 66.7% qopqjtybut (rkhsgwlqlx ) View more	Positive	14 Sep 2024
NCT05081609 (IL-Believe, Biospace) Manual	Phase 1/2	Small Cell Lung Cancer \| Melanoma \| Colorectal Cancer	-	TransCon IL-2 β⁄γ +TransCon TLR7/8 Agonist (melanoma)	cqrsthaehb(xiqrxhswoq) = ipnkvtrrqd zqfrfpkbvo (twhanikefj )	Positive	03 Jun 2024
				TransCon IL-2 β/γ (colorectal cancer)	vuwbianmji(gvaxspeawy) = wxqquzeiwz jzmzuugbvy (emvjopygcj )
NCT05081609 (IL Believe, ASCO2024) Manual	Phase 1/2	Solid tumor absolute lymphocyte counts (ALC) \| cytotoxic lymphocytes (CLs) \| soluble CD25 ... View more	46	TransCon IL-2 β/γ alone	didgzdrsko(oidamzxqzi) = zpyfibxyvb aeehtrynnw (cuwlnlzfbw ) View more	Positive	24 May 2024
				TransCon IL-2 β/γ + pembrolizumab	didgzdrsko(oidamzxqzi) = kuuihakjyn aeehtrynnw (cuwlnlzfbw )
NCT05081609 (IL-Believe, ESMO 12023 \| ESMO 22023) Manual	Phase 1/2	Advanced Malignant Solid Neoplasm	39	TransCon IL-2 β/γ (20 to 160 mcg/kg)	jybqgvoagh(bcuiuqhmej) = gnbuixqohs hhzeacjidj (tfvmvkpxub ) View more	Positive	23 Oct 2023
				TransCon IL-2 β/γ (20 to 80 mcg/kg) + pembrolizumab	jybqgvoagh(bcuiuqhmej) = ceumvtnmvw hhzeacjidj (tfvmvkpxub )
NCT05081609 (IL Believe, ASCO 12023 \| ASCO 22023) Manual	Phase 1/2	Advanced Malignant Solid Neoplasm	27	TransCon IL-2 β/γ	agtklvcmaa(dpwgzauhup) = 1 Dose Limiting Toxicity of G3 CRS was reported at DL4. bcsvutjvsw (mkejppuubd ) View more	Positive	31 May 2023
				TransCon IL-2 β/γ+Pembrolizumab

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TransCon IL-2 beta/gamma(Ascendis Pharma)

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