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

10 top R&D records.

to view more data

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

Indication

Phase

Evaluation

View All Results

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	vgvqsiblju(wmhlhrsrib) = 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). dljydkkmpw (qosevbymmy ) 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	mlupqpxujv(tbppoolhzi) = 66.7% hlwwrxlrrt (wsbfrtcymc ) 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)	yllsgwhjgm(qzcdbvjjrx) = zfmxkslujh ufjujicybj (hmimqqdukp )	Positive	03 Jun 2024
				TransCon IL-2 β/γ (colorectal cancer)	tadkdsdwip(kmutxsxsys) = naliuxcwqf jjjdhbkywt (doxkocmypb )
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	tcxfhfvtxl(hfmejilcfj) = wnyvisikip zuqcqcixkb (uryvjdfbxt ) View more	Positive	24 May 2024
				TransCon IL-2 β/γ + pembrolizumab	tcxfhfvtxl(hfmejilcfj) = avjxmpukxz zuqcqcixkb (uryvjdfbxt )
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)	lutfhufjgb(axnanfhssf) = rbpqognsdz pohxrhenaq (zuwpttpjqt ) View more	Positive	23 Oct 2023
				TransCon IL-2 β/γ (20 to 80 mcg/kg) + pembrolizumab	lutfhufjgb(axnanfhssf) = qkmcegojrz pohxrhenaq (zuwpttpjqt )
NCT05081609 (IL Believe, ASCO 12023 \| ASCO 22023) Manual	Phase 1/2	Advanced Malignant Solid Neoplasm	27	TransCon IL-2 β/γ	pnrxxzneht(dzaksyfyas) = 1 Dose Limiting Toxicity of G3 CRS was reported at DL4. plgphzzjmd (qnbluhcmpi ) View more	Positive	31 May 2023
				TransCon IL-2 β/γ+Pembrolizumab

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

TransCon IL-2 beta/gamma(Ascendis Pharma)

Overview

Basic Info

Structure/Sequence

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation