The OPAL Study: AVM0703 for Treatment of Lymphoid Malignancies
ConditionLymphoid Malignancies
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age12-95
SponsorAVM Biotechnology Inc
About this trial
This is an open-label, Phase 1/2 study designed to characterize the safety, tolerability, Pharmacokinetics(PK), and preliminary antitumor activity of AVM0703 administered as a single intravenous (IV) infusion to patients with lymphoid malignancies.
Eligibility criteria
Qualifiers
1. Age ≥12 years and weight ≥40 kg;
DLBCL, including arising from follicular lymphoma;
High-grade B-cell lymphoma;
MCL;
Disqualifiers
Adequately treated local basal cell or squamous cell carcinoma of the skin;
Adequately treated carcinoma in situ without evidence of disease;
Adequately treated papillary, noninvasive bladder cancer; or
Other cancer that has been in complete remission for ≥2 years. Patients with low-grade prostate cancer, on active surveillance, and not expected to clinically progress over 2 years are allowed;
Trial design
Treatments tested in this trial
- AVM0703
Treatment groups
144 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
AVM Biotechnology Inc
Lead sponsor
Medpace, Inc.
Collaborator
Source ClinicalTrials.gov