Surovatamig for Chronic Lymphocytic Leukaemia

(SOUNDTRACK-C1 Trial)

Not yet recruiting at 12 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 3

Sponsor: AstraZeneca

Must not be taking: Immunosuppressants

Disqualifiers: Richter's transformation, CNS involvement, HIV, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 12

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to evaluate the therapeutic benefit and safety of subcutaneous (SC) Surovatamig monotherapy as consolidation therapy in patients with Chronic Lymphocytic Leukaemia (CLL)/ Small Lymphocytic Lymphoma (SLL) with unmutated IGHV (uIGHV).

Are You a Good Fit for This Trial?

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.

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

How Is the Trial Designed?

Group I: Phase III-Arm A: Surovatamig SC Experimental Treatment 1 Intervention

Participants will receive Surovatamig at RP3D subcutaneously for 6 cycles (each cycle is 28 days in length).

Group II: Dose Optimisation and Safety run-in (DOSRI)- Surovatamig Dose 1 Experimental Treatment 1 Intervention

Participants will receive Surovatamig Dose 1 subcutaneously (SC) for 6 cycles (each cycle is 28 days in length).

Group III: DOSRI-Surovatamig Dose 2 Experimental Treatment 1 Intervention

Participants will receive Surovatamig Dose 2 SC for 6 cycles (each cycle is 28 days in length).

Group IV: Phase III-Arm B: Observation Active Control 1 Intervention

Participants will undergo observation for 24 weeks.

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

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

Parexel

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland