Adagene, Inc. ((ADAG)) announced an update on their ongoing clinical study.
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Study Overview: Adagene, Inc. (ADAG) is conducting a Phase 1b/2 clinical study titled ‘A Phase 1b/2, Open-Label, Dose Escalation and Expansion Study of ADG126 in Combination With Pembrolizumab (Anti PD-1 Antibody) in Patients With Advanced/Metastatic Solid Tumors.’ The study aims to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of the ADG126 and pembrolizumab combination in patients with advanced or metastatic solid tumors. This study is significant as it explores a novel combination therapy that could potentially enhance treatment efficacy for these challenging cancer types.
Intervention/Treatment: The study tests the combination of ADG126, an anti-CTLA-4 monoclonal antibody, with pembrolizumab (KEYTRUDA®), a PD-1 receptor-blocking antibody. This combination aims to improve the immune response against tumors, potentially offering a new treatment avenue for patients with advanced cancers.
Study Design: The study is interventional, with a non-randomized, sequential intervention model. It is open-label, meaning both researchers and participants know the treatment being administered. The primary purpose is treatment-focused, aiming to assess the combination’s efficacy and safety.
Study Timeline: The study began on May 16, 2022, and is currently recruiting participants. The primary completion and estimated completion dates are not specified, but the latest update was submitted on May 30, 2025. These timelines are crucial for tracking progress and anticipating results that could influence treatment protocols.
Market Implications: This study update could positively impact Adagene’s stock performance and investor sentiment, as successful results may lead to a new, effective cancer treatment option. The involvement of Merck Sharp & Dohme LLC as a collaborator highlights the potential industry interest and competitive edge this study could provide in the oncology market.
The study is ongoing, with further details available on the ClinicalTrials portal.