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TransCon IL-2 ß/ү

DRUG2 trials

Sponsors

Ascendis Pharma Oncology Division A/S

Conditions

Locally advanced or metastatic solid tumor malignanciesStage III-IVA Resectable Locoregionall Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)neoadjuvant melanoma and neoadjuvant non-small cell lung cancerplatinum resistant ovarian cancerpost-anti-pd-1 melanomapost-anti-pd-L1 non-small cell lung cancerpost-anti-pd-L1 small cell lung cancersecond line or later HER2+ breast cancer

Phase 1

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
RecruitingCTIS2023-509143-27-00
Ascendis Pharma Oncology Division A/SLocally advanced or metastatic solid tumor malignancies, neoadjuvant melanoma and neoadjuvant non-small cell lung cancer, platinum resistant ovarian cancer +5
Start: 2023-11-27Target: 120Updated: 2025-12-26

Phase 2

BelieveIT-201: A Randomized, Phase 2, Open-label Trial of TransCon TLR7/8 Agonist in Combination with Pembrolizumab, TransCon TLR7/8 Agonist in Combination with TransCon IL-2 β/γ, or Pembrolizumab Monotherapy as Neoadjuvant Therapy in Participants with Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)
CompletedCTIS2023-506092-10-00
Ascendis Pharma Oncology Division A/SStage III-IVA Resectable Locoregionall Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)
Start: 2024-03-11End: 2025-03-28Target: 43Updated: 2025-05-07