Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • AVM0703

    Drug

    Intravenous infusion over \~1 hours

Treatment groups

144 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: DLBCL and high-grade B-cell lymphomaExperimental treatment 1 intervention
Group B: MCL (Chronic Lymphoid Leukemia)Experimental treatment 1 intervention
Group C: Primary Mediastinal Large B-cell lymphomaExperimental treatment 1 intervention
Group D: Burkitt or Burkitt-like lymphoma/leukemiaExperimental treatment 1 intervention
Group E: CLL/SLLExperimental treatment 1 intervention
Group F: B- or T-ALLExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Phase 1: incidence of Adverse events

The primary endpoint for the Phase 1 portion of the study is the incidence of Adverse events (AEs), including DLTs.

Time frame
Year One

Secondary outcomes

1

Phase 2: ORR

ORR (CR plus partial response \[PR\]) at 28 days post infusion

Time frame
Year Two

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AVM Biotechnology Inc

Lead sponsor

Medpace, Inc.

Collaborator

Source ClinicalTrials.gov
Apply now