420 Participants NeededMy employer runs this trial

Surovatamig for Chronic Lymphocytic Leukaemia

(SOUNDTRACK-C1 Trial)

Recruiting at 36 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Surovatamig for individuals with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) who possess a specific genetic marker known as unmutated IGHV. The study aims to determine if Surovatamig, administered as a subcutaneous injection, is safe and effective as a follow-up treatment after initial therapy. Participants will either receive varying doses of Surovatamig or be observed for a period. This trial suits those diagnosed with CLL or SLL, who have completed their first round of treatment, and have the genetic feature unmutated IGHV. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that Surovatamig is likely to be safe for humans?

Research has shown that Surovatamig has been tested in people before. In these studies, the treatment proved generally safe, with most participants experiencing no serious side effects. The most common side effects were mild, such as redness or swelling at the injection site, which is typical for subcutaneous treatments.

Another study on its use for different conditions also found Surovatamig to be mostly safe, with serious side effects being rare. This suggests that Surovatamig might be well-tolerated by people with Chronic Lymphocytic Leukemia.

The current trial is in a later stage, indicating that the treatment has already demonstrated a good level of safety in earlier tests. While all medicines can have side effects, Surovatamig has been deemed safe enough for testing in more people.12345

Why do researchers think this study treatment might be promising for CLL?

Researchers are excited about Surovatamig for chronic lymphocytic leukemia (CLL) because it offers a new approach to treatment. Unlike traditional therapies such as chemotherapy and targeted drugs like ibrutinib or venetoclax, Surovatamig is administered subcutaneously, which can be more convenient for patients compared to intravenous or oral options. Additionally, it works by a novel mechanism that targets specific pathways involved in CLL, potentially leading to more effective control of the disease. This unique delivery method and mechanism of action make Surovatamig a promising option that could improve patient outcomes.

What evidence suggests that Surovatamig could be an effective treatment for Chronic Lymphocytic Leukaemia?

Research has shown that surovatamig may help treat certain blood cancers. One study found that patients who had already received CD19-targeted therapy had a 67% response rate with one dose of surovatamig and a 100% response rate with a higher dose. Another study on patients with B-cell non-Hodgkin lymphoma reported a 96% response rate, with 85% of patients achieving complete remission. This trial will evaluate different doses of surovatamig for patients with Chronic Lymphocytic Leukemia (CLL), including those with unmutated IGHV, to gather specific data on its effectiveness for CLL.23456

Are You a Good Fit for This Trial?

This trial is for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have a specific genetic marker called unmutated IGHV, have finished their first round of treatment, are in good general health, and agree to use effective birth control.

Inclusion Criteria

I have SLL and at least one tumor that can be measured.
I am able to care for myself and do daily activities.
My blood, liver, kidney, and heart functions are normal.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Optimisation and Safety Run-in

Participants receive Surovatamig at two dose levels to determine the recommended Phase III dose

24 weeks
6 cycles (each cycle is 28 days)

Phase III - Treatment

Participants receive Surovatamig at the recommended Phase III dose as consolidation therapy

24 weeks
6 cycles (each cycle is 28 days)

Phase III - Observation

Participants undergo observation without active treatment

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Surovatamig

Trial Overview

The study tests Surovatamig given as an injection under the skin by itself (monotherapy), used after initial treatment to help keep CLL/SLL from coming back. All participants receive this therapy.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Active Control

Group I: Phase III-Arm A: Surovatamig SCExperimental Treatment1 Intervention
Group II: Dose Optimisation and Safety run-in (DOSRI)- Surovatamig Dose 1Experimental Treatment1 Intervention
Group III: DOSRI-Surovatamig Dose 2Experimental Treatment1 Intervention
Group IV: Phase III-Arm B: ObservationActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Parexel

Industry Sponsor

Trials
322
Recruited
137,000+
Peyton Howell profile image

Peyton Howell

Parexel

Chief Executive Officer

Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois

Dr. Austin Smith profile image

Dr. Austin Smith

Parexel

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland

Citations

A Study of AZD0486 Monotherapy or in Combination with ...

The purpose of this study is to assess the safety and efficacy of surovatamig (formerly AZD0486) administered as monotherapy or in combination with other ...

Astra goes subcutaneous in its Merck race | ApexOnco

The primary efficacy endpoint will be progression-free survival. Surovatamig doesn't appear to have produced clinical data yet in CLL, although ...

Surovatamig for Chronic Lymphocytic Leukaemia · Info for ...

The purpose of this study is to evaluate the therapeutic benefit and safety of subcutaneous (SC) Surovatamig monotherapy as consolidation therapy in ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41780654/

Systematic review of real-world data on the effectiveness ...

Results: Ibrutinib (IBR) demonstrated consistent effectiveness in multiple RWD studies, with 12- and 24-month OS rates of 87-100% and 78-100%, ...

Advancing Immunotherapy in Chronic Lymphocytic Leukemia

Based on current clinical experience, BTKi and BCL2i are highly effective. Although they do not cure the disease, they provide most patients with significantly ...

Surovatamig as Consolidation Therapy in Participants With ...

The purpose of this study is to evaluate the therapeutic benefit and safety of subcutaneous (SC) Surovatamig monotherapy as consolidation ...