Recent Updates
Recently added Catalysts

AVL-292

Phase 3

B Cell Non-Hodgkin's Lymphoma | Small molecule | Oncology |Bristol-Myers Squibb Company|Trials Updated: Nov 8, 2019

AVL-292 development status

Highest phase Phase 3 run by Ascentage Pharma Group Inc. (NCT06104566)
Phase scored for BMYPhase 1
Registered trials 2 across 2 sponsors since May 2011

AVL-292 target and mechanism

ModalitySmall molecule

Also known as Btk inhibitor

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment113

FDA Designations

No designations recorded

AVL-292 clinical trials

AVL-292 · 1 trial · 3 indications

Phase 1 1
NCT01351935Escalating Dose Study in Subjects With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, and Waldenstrom's MacroglobulinemiaB Cell Non-Hodgkin's Lymphoma
COMPLETED113 Analytics
PHASE1COMPLETED
Escalating Dose Study in Subjects With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, and Waldenstrom's Macroglobulinemia
B Cell Non-Hodgkin's LymphomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety, tolerability,and dose limiting toxicities will be determined using AEs,PE,ophthalmologic examinations,clinical laboratory tests,vital signs, ECGs and echocardiograms/MUGA scans.
with in the first 28 days after initiation of once daily oral dosing

Secondary Endpoints

Establish recommended Phase 2 dose, after completing dose escalation in Part 1 and evaluating accumulated safety,PK,and PD data from the dose escalation phase (Part1)
Completion of Part 1 dose escalation phase of study
Evaluate the Pharmacokinetic parameters of AVL-292
First 28 days of dosing
Evaluate the Pharmacodynamics of AVL-292 by measurement of free Btk
First 28 days of dosing
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AVL-292EXPERIMENTAL -

Interventions

NameTypeDescription
AVL-292DRUG125 mg to 625 mg orally, once a day, for 28 days (28 days equals 1 cycle). Number of cycles: until progression or unacceptable toxicity develops
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: * Women and men ≥18 years of age * Body weight ≥50 kg. * Confirmed diagnosis of B cellNon-Hodgkin Lymphoma(according to World Health Organization \[WHO\] classification)including Chronic Lymphocytic Leukemia/Small cell Lymphocytic Leukemia (International Workshop),or Waldenstrom...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about AVL-292

What is AVL-292 used for?

AVL-292 is an investigational small molecule being studied for B cell non-Hodgkin's lymphoma, a type of blood cancer. It was evaluated in a Phase 1 trial that also enrolled patients with chronic lymphocytic leukemia and Waldenstrom's macroglobulinemia, reflecting a broader interest in B cell malignancies.

Who is developing AVL-292?

AVL-292 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company sponsored the Phase 1 study of the compound in patients with relapsed or refractory B cell cancers.

What phase is AVL-292 in?

AVL-292 is in Phase 1 clinical development. It has completed one Phase 1 dose-escalation trial in patients with relapsed or refractory B cell non-Hodgkin's lymphoma, chronic lymphocytic leukemia, and Waldenstrom's macroglobulinemia. It is investigational and has not been approved by the FDA.

What clinical trials is AVL-292 in?

AVL-292 has been studied in one completed Phase 1 trial, NCT01351935, titled an escalating dose study in subjects with relapsed or refractory B cell non-Hodgkin's lymphoma, chronic lymphocytic leukemia, and Waldenstrom's macroglobulinemia. The trial enrolled 113 patients in the United States and has completed.

How was the AVL-292 Phase 1 trial designed?

The AVL-292 Phase 1 trial, NCT01351935, was an uncontrolled, open-label dose-escalation study, not randomized and not double blinded. It enrolled 113 adults aged 18 and older of any sex with relapsed or refractory B cell non-Hodgkin's lymphoma, chronic lymphocytic leukemia, or Waldenstrom's macroglobulinemia, and it has completed.