Phase 2a results of SQ3370, a doxorubicin-based click chemistry therapeutic in patients with advanced STS: Planned interim analysis.
作者:Nam Quoc Bui, Vineet Kwatra, Christopher W. Ryan, Erlinda Maria Gordon, Maša Alečković, Sangeetha Srinivasan, Tri‐Hung Nguyen, José Manuel Mejía Oneto, Esteban Abella-Dominicis, Sant P. Chawla · 发表于:Journal of Clinical Oncology · 年份:2024 · DOI:10.1200/jco.2024.42.16_suppl.11555 · 被引用次数:6 · 研究领域:Click Chemistry and Applications、HER2/EGFR in Cancer Research、Chronic Myeloid Leukemia Treatments
11555 Background: Shasqi is a clinical stage biotech that uses click chemistry, a Nobel Prize winning technology, to selectively activate cancer treatments at the tumor. The Click Activated Protodrugs Against Cancer (CAPAC) platform comprises of 1) tumor targeting agents, which carry an activator, and 2) attenuated cancer drugs, which are selectively activated at the tumor by the targeting agent through click chemistry, maximizing therapeutic index and minimizing toxicities. We have demonstrated clinical proof of concept with SQ3370, which uses an intratumorally injected SQL70 biopolymer (bp) with a doxorubicin (Dox) protodrug (SQP33) injected systemically. As previously reported RP2D of SQP33=12x Dox. (NCT04106492). Methods: Dox naïve patients (pts) received 10/20 mL bp and protodrug IV QD x 3 or 5. Key eligibility: locally advanced or metastatic soft tissue sarcomas (STS). The objective was to explore bp dose and schedule of the RDP2 (same dose per cycle) in advanced or metastatic STS. Results: Fourteen patients with predominantly metastatic (11/14) STS, all unresectable, were enrolled at the 1st interim analysis. Median age 58 years (32-89), ECOG=1 (11/14). Therapy was well tolerated. The most common TEAE was nausea and fatigue (all grade ≤ 2), with 1 subject in each group having a manageable grade ≤ 3 TEAE-related discontinuations. The majority of subjects did not suffer clinical myelosuppression grade ≤ 1 neutropenia (10/14), anemia (13/14), or thrombocytopenia (13/14), ...