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
Metastatic Solid Tumor	Phase 2	Singapore	Ascendis Pharma Oncology Division A/S	11 Jan 2022
Platinum-Resistant Ovarian Carcinoma	Phase 2	United States	Ascendis Pharma Oncology Division A/S	11 Jan 2022
Platinum-Resistant Ovarian Carcinoma	Phase 2	Spain	Ascendis Pharma Oncology Division A/S	11 Jan 2022
Platinum-Resistant Ovarian Carcinoma	Phase 2	Australia	Ascendis Pharma Oncology Division A/S	11 Jan 2022
Platinum-Resistant Ovarian Carcinoma	Phase 2	Singapore	Ascendis Pharma Oncology Division A/S	11 Jan 2022
Platinum-Resistant Ovarian Carcinoma	Phase 2	Taiwan Province	Ascendis Pharma Oncology Division A/S	11 Jan 2022
Platinum-Resistant Ovarian Carcinoma	Phase 2	Poland	Ascendis Pharma Oncology Division A/S	11 Jan 2022
Platinum-Resistant Ovarian Carcinoma	Phase 2	Italy	Ascendis Pharma Oncology Division A/S	11 Jan 2022
Platinum-Resistant Ovarian Carcinoma	Phase 2	Canada	Ascendis Pharma Oncology Division A/S	11 Jan 2022
Platinum-Resistant Ovarian Carcinoma	Phase 2	Belgium	Ascendis Pharma Oncology Division A/S	11 Jan 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05081609 (IL Believe, ESMO2024)	Phase 2	Platinum-Resistant Ovarian Carcinoma cytotoxic lymphocytes (CLs)	12	TransCon IL-2 β/γ + Pemetrexed	jbhohigghp(vlvleuqcdq) = 66.7% ihexrdderb (eomhmfdasg ) 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)	(neylctluia) = qknxinlyan kepmmklxnm (gwtdfqhevy )	Positive	03 Jun 2024
				TransCon IL-2 β/γ (colorectal cancer)	(nqrmmszezl) = twgrcyvcbs puddjpfbpv (obaovddoel )
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	(wocstytueb) = jqzusdksdq uacbpubqad (klrrqtemsd ) View more	Positive	24 May 2024
				TransCon IL-2 β/γ + pembrolizumab	(wocstytueb) = fdsfmsveox uacbpubqad (klrrqtemsd )
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)	(geoagiqzwl) = kkmwsjmowr mcxlmczzuu (ctqzlnbrre ) View more	Positive	23 Oct 2023
				TransCon IL-2 β/γ (20 to 80 mcg/kg) + pembrolizumab	(geoagiqzwl) = qtadrxdcdl mcxlmczzuu (ctqzlnbrre )
NCT05081609 (IL Believe, ASCO 12023 \| ASCO 22023) Manual	Phase 1/2	Advanced Malignant Solid Neoplasm	27	TransCon IL-2 β/γ	(mvveifuikj) = 1 Dose Limiting Toxicity of G3 CRS was reported at DL4. xhcbqnrtvj (zfurqqamub ) 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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