VAY736 for Advanced Cancer

(AMBER Trial)

Not currently recruiting at 52 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Novartis Pharmaceuticals

Must not be taking: B-cell depleting, Hepatotoxic drugs

Disqualifiers: Decompensated cirrhosis, Overlap syndrome, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called VAY736 for people with advanced cancer who haven't responded well to standard therapies. The main goal is to determine the safety and effectiveness of different doses of VAY736. Participants will receive one of three doses of VAY736 or a placebo (a substance with no active treatment) through random assignment. Those with advanced cancer who have tried standard treatments without success might be suitable for this trial. As a Phase 2 trial, this research measures how well VAY736 works in an initial, smaller group, offering a chance to explore new treatment possibilities.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but you cannot regularly use medications that harm the liver.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that VAY736, also known as ianalumab, has been tested in earlier studies to assess its safety and tolerability. In these studies, most participants tolerated VAY736 well, experiencing mild to moderate side effects. Common side effects included redness and swelling at the injection site, or flu-like symptoms such as fever and tiredness.

One study examined different doses of VAY736 and found it safe at all tested levels. Serious side effects were rare, and no increase in severe side effects occurred compared to those who received a placebo.

Overall, the evidence suggests that VAY736 is safe for people, with manageable side effects. This information may help prospective participants feel more informed about the treatment's safety when considering joining a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about VAY736 for advanced cancer because it represents a new approach in cancer therapy. Unlike standard treatments like chemotherapy and radiation that target rapidly dividing cells, VAY736 is designed to modulate the immune system, offering a potentially more targeted and less toxic therapy. This drug works as a monoclonal antibody, which may enhance the body's natural ability to fight cancer cells without damaging healthy tissue. With multiple dosing options being explored, there's hope for personalized treatment plans that could improve outcomes for patients with advanced cancer.

What evidence suggests that VAY736 could be an effective treatment for advanced cancer?

Research has shown that VAY736 may help treat certain types of cancer. In studies, VAY736, when combined with other treatments, reduced the disease in cases such as drug-resistant acute lymphoblastic leukemia (ALL) and chronic lymphocytic leukemia (CLL). For autoimmune diseases, VAY736 decreased disease activity and was well-tolerated for a year. These findings suggest that VAY736 could effectively target specific disease processes in advanced cancers. Although researchers continue to study the drug, these early results offer hope for its effectiveness. ^{2 3 4 6 7}

Who Is on the Research Team?

Study Director

Principal Investigator

Novartis Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for individuals with active autoimmune hepatitis (AIH) confirmed by liver biopsy, diagnosed according to international standards, and who haven't fully responded to or can't tolerate standard treatments. It's not for those with advanced cirrhosis, a history of drug-related AIH, recent B-cell depleting therapy use, overlap syndromes like AIH+PBC/PSC, cancer history, or substance abuse.

Inclusion Criteria

AIH diagnosed per International Autoimmune Hepatitis Group

My condition did not fully improve or I couldn't tolerate the standard treatment.

Liver biopsy with Ishak modified HAI indicating active AIH

Exclusion Criteria

I haven't used B-cell depleting therapy in the last year or my B-cell count is below 50.

I have had liver inflammation caused by medication.

I have had cancer in any part of my body before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive VAY736 or placebo in a randomized, double-blind, placebo-controlled manner

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Subsequent Study Part

A new group of patients will be enrolled to test the efficacy and safety of VAY736 in a parallel group design

What Are the Treatments Tested in This Trial?

Interventions

• VAY736

Trial Overview The trial is testing VAY736 in patients with Hepatitis A and Autoimmune Hepatitis. Participants will either receive the actual VAY736 medication or a placebo to compare the effectiveness and safety of this potential new treatment option.

How Is the Trial Designed?

Group I: Arm 3 Experimental Treatment 1 Intervention

VAY736 Dose 3

Group II: Arm 2 Experimental Treatment 1 Intervention

VAY736 Dose 2

Group III: Arm 1 Experimental Treatment 1 Intervention

VAY736 Dose 1

Group IV: Arm 4 Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Citations

1. onclive.com onclive.com/view/ianalumab-ibrutinib-combo-shows-promising-activity-in-cll

Ianalumab/Ibrutinib Combo Shows Promising Activity in CLL The results provide evidence of a potential approach to discontinue ibrutinib, which is generally indefinite treatment, by VAY736 add-on therapy ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05350072

Two-arm Study to Assess Efficacy and Safety of Ianalumab ... The purpose of the study is to demonstrate the clinical efficacy, safety and tolerability of ianalumab (VAY736) administered subcutaneously (s.c.) monthly ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6606383/

Combination therapy for treating advanced drug-resistant ... VAY736 antibody and NK cell treatments significantly decreased ALL disease burden and provided survival benefit in vivo. However, if the disease was advanced, ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003496724151801

OP0089 PHASE 2 SAFETY AND EFFICACY OF ... Conclusion: Treatment of SLE with ianalumab up to 1 year was well tolerated, and data suggest longer exposure provides further clinical and laboratory benefits.

5. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(21)02251-0/abstract

a randomised, double-blind, placebo-controlled, phase 2b ... The study met its primary objective, showing a dose-related decrease in disease activity as measured by ESSDAI at week 24. Overall, ianalumab ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04903197

NCT04903197 | Study of VAY736 as Single Agent and in ... The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK), immunogenicity and preliminary efficacy of VAY736 alone or in ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34861168/

Safety and efficacy of subcutaneous ianalumab (VAY736) ... A new biologic, ianalumab (VAY736), with two modes of suppressing B cells, has previously shown preliminary efficacy. This dose-finding trial ...