Dynavax Technologies Corp. (DVAX) announced that it has initiated a phase 1/2 clinical trial to assess the safety and preliminary efficacy of SD-101, an investigational Toll-like receptor or "TLR" 9 agonist, in adults with untreated low-grade B-cell lymphoma.
In this multicenter study, known as LYM-01, SD-101 is administered intratumorally in combination with localized low-dose radiation. The open-label, dose escalation and expansion design of LYM-01 is intended to accelerate dose optimization while simultaneously assessing the safety, tolerability and initial local and distant antitumor activity of SD-101.
LYM-01 is an open-label, single arm, multicenter, dose-escalation and expansion study designed to evaluate the safety and preliminary efficacy of localized low-dose radiation therapy and intratumoral SD-101 injection into a single target lesion. It will include up to 25 patients diagnosed with untreated low-grade B-cell lymphomas who do not require immediate systemic therapy and are appropriate candidates for "watch and wait."
Treatment consists of local radiation given over 2 days followed by 5 weekly intratumoral injections of 1, 2, 4, or 8 mg of SD-101. The total duration of patient participation in this study is up to 2 years.
The primary objectives of LYM-01 are to assess safety and tolerability of escalating doses of SD-101 administered with low-dose radiation; to evaluate the pharmacodynamic profile of interferon-inducible genes in whole blood 24 hours after injection; and to determine the maximum tolerated dose or optimal dose.
A key secondary objective of the study is assessment of the objective response to SD-101 in untreated lesions distant from the lesion in which SD-101 and radiation were administered. All tumor responses are assessed according to the Cheson criteria.
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