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Clinical Trials List

Protocol NumberASND0038

NCT Number(ClinicalTrials.gov Identfier)NCT05980598

2024-01-01 - 2027-07-31

Phase II

Recruiting6

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

Trial Applicant

Syneos Health
Sponsor
Trial scale

Multi-Regional Multi-Center
Update

2025/11/05

Investigators and Locations

Principal Investigator Ching Yun Hsieh 無

China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator YI-CHUN LIU Division of Radiation Therapy

Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 簡志彥無

Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hung-Ming Wang 無

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hui-Ching Wang 無

Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 張展旗

National Taiwan University Hospital

Co-Principal Investigator

Shang-Yin Wu

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Head and Neck Neoplasms

Objectives

Primary: • Evaluate the major pathological response (MPR) of TransCon TLR7/8 agonists combined with pembrolizumab and TransCon TLR7/8 agonists combined with TransCon IL-2 β/γ compared to pembrolizumab monotherapy. Secondary: • Evaluate the antitumor activity of TransCon TLR7/8 agonists combined with pembrolizumab and TransCon TLR7/8 agonists combined with TransCon IL-2 β/γ compared to pembrolizumab monotherapy. • Evaluate the safety and tolerability of TransCon TLR7/8 agonists combined with pembrolizumab and TransCon TLR7/8 agonists combined with TransCon IL-2 β/γ. Exploratory: • Evaluate plasma TransCon IL-2 β/γ exposure after concomitant administration of TransCon TLR7/8 agonists. • Evaluate the effects of TransCon TLR7/8 agonists combined with pembrolizumab. Plasma exposure to pembrolizumab or in combination with TransCon IL-2 β/γ • Confirm and evaluate blood and tumor pharmacodynamic biomarkers after treatment with TransCon TLR7/8 agonists in combination with TransCon IL-2 β/γ compared to treatment with pembrolizumab, or treatment with TransCon TLR7/8 agonists in combination with pembrolizumab • Evaluate the immunogenicity of TransCon IL-2 β/γ (inactive prodrug) and the released active IL-2 β/γ in applicable groups.

Test Drug

TransCon IL-2 β/γTransCon TLR7/8 Agonist

Active Ingredient

TransCon IL-2 β/γ
TransCon TLR7/8 Agonist

Dosage Form

180
084

Dosage

1 mg/mL
0.5 mg/mL resiquimod

Endpoints

MPR, as assessed by an external independent pathology review committee (IPR), is defined as 10% or more of invasive squamous cell carcinoma (SCC) in the primary tumor resection specimen and lymph nodes in all sampling areas.

Inclution Criteria

Inclusion Criteria:

Has local histologically confirmed new diagnosis of resectable, non-metastatic, SCC that is either: Stage III tumor HPV-positive oropharyngeal primary that is tumor size (T) 4, lymph node involvement (N) 0-2, no distant metastases (M) 0; Stage III or IVA oropharyngeal tumor HPV-negative; or Stage III or IVA larynx/hypopharynx/oral cavity primaries regardless of HPV status (per American Joint Committee on Cancer [AJCC] Staging, 8th edition).
Has available archived or fresh core or excisional biopsy of a tumor lesion. Note: Fine needle aspirations may be allowed after discussion with Medical Monitor.
Is eligible and plans for primary LA-HNSCC surgery based on investigator decision and per local practice.
Has results from tumor HPV status by p16 immunohistochemistry (IHC) for oropharyngeal tumors. (HPV DNA analysis for HPV tumor status is acceptable if that is the local standard of care analysis.)
Has adequate organ function at screening.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Has at least one lesion that is deemed by the investigator to be easily and safely accessible for IT injection.

Exclusion Criteria

Exclusion Criteria:

Active autoimmune conditions.
Has significant cardiac disease.
Has a known bleeding disorder that is deemed to place the participant at unacceptable risk for bleeding complications from IT injections or biopsies.
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (in doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization.

The Estimated Number of Participants

Taiwan

20 participants
Global

92 participants