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Experimental combo for tough blood cancers hits early snag

NCT ID NCT04702425

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This early-stage trial tested a combination of two experimental drugs, VOB560 and MIK665, in 37 people with relapsed or refractory non-Hodgkin lymphoma, acute myeloid leukemia, or multiple myeloma. The drugs aim to block proteins that help cancer cells survive, forcing them to die. The study was terminated early, so results on safety and effectiveness are limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
VOB560 and MIK665 (two experimental drugs that block proteins protecting cancer cells)
What this could lead to
If it works, this combination could offer a new treatment option for people with blood cancers that have stopped responding to standard therapies.
What could go wrong
This was a very early (phase 1) trial that was terminated, so we don't know if the combination is safe or effective. The drugs may cause serious side effects or fail to shrink tumors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

37 people

The number who actually took part.

Started

Jun 2021

Finished

Jul 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosis of one of the following hematologic malignancies: * relapsed and/or refractory patients with non-Hodgkin lymphoma with radiographically measurable disease with a clearly demarcated nodal lesion at least 1.5 cm in its largest dimension or a target extra nodal lesion at least 1.0 cm in its largest dimension * relapsed and/or refractory patients with MM treated with at least 2 prior regimens, including an IMiD, a proteasome inhibitor proteasome inhibitor, and anti-CD38 antibody (if available) and not eligible for treatment with other regimens known to provide clinical benefit, as determined by the investigator. * relapsed and/or refractory patients with Acute Myeloid Leukemia (AML), pathologically confirmed diagnosis as defined by the WHO Classification and with ≥ 5% blasts in bone marrow. Following ≥ 1 prior therapies who have relapsed or exhibited refractory disease (primary failure) and are deemed by the investigator not to be candidates for standard therapy, including re-induction with cytarabine or other established therapeutic regimens for patients with AML (patients who are suitable for standard re-induction chemotherapy or hematopoietic stem cell transplantation and willing to receive it are excluded). * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2. * Patient must be a candidate for serial bone marrow aspirate and/or biopsy according to the institution's guidelines and be willing to undergo a bone marrow aspirate and/or biopsy at screening, during and at the end of therapy on this study. Exclusion Criteria: 1. History of severe hypersensitivity reactions to any ingredient of study treatment and/or their excipients. 2. Systemic antineoplastic therapy (including cytotoxic chemotherapy, alpha-interferon, kinase inhibitors or other targeted small molecules, and toxin immunoconjugates) or any experimental therapy within 14 days or 5 half-lives, whichever is shorter, before the first dose of study treatment. 3. High-risk patients for Tumor Lysis Syndrome according to Cairo et al 2010 criteria or local guidelines. 4. Impaired cardiac function or clinically significant cardiac disease, or history or current diagnosis of ECG abnormalities indicating significant risk of safety including any of the following: 1. Concomitant clinically significant cardiac arrhythmias, e.g. sustained ventricular tachycardia, and clinically significant second- or third-degree AV block without a pacemaker 2. Any history of clinical important abnormalities in rhythm, conduction or morphology of resting ECG e.g. complete left bundle branch block, third degree heart block 3. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, significant hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age 4. Resting QTcF ≥450 msec (male) or ≥460 msec (female) at pre-treatment 5. Use of agents known to prolong the QT interval unless it can be permanently discontinued for the duration of study. 6. Abnormal echocardiogram (ECHO) or multi-gated acquisition scan (MUGA) at baseline (left ventricular ejection fraction \[LVEF\] \<50%) 7. Symptomatic congestive heart failure (New York Heart Association ≥ 3) 8. Findings observed in the baseline cardiac MRI that might reflect an increased risk for cardiac adverse events. 5. Use of hematopoietic colony-stimulating growth factors (e.g. G-CSF, GM-CSF, M-CSF), thrombopoietin mimetics or erythroid stimulating agents ≤ 2 weeks prior to start of study treatment. If thrombopoietin mimetics or erythroid stimulating agents were initiated more than 2 weeks prior to the first dose of study treatment and the patient is on a stable dose, they can be maintained. 6. For AML patients: Peripheral blast counts \> 25,000 blasts / mm3. Patients can receive hydroxyurea to control the peripheral blast counts as long as hydroxyurea can be stopped at least 24 hours prior to obtaining PD biomarkers at screening/baseline. Hydroxyurea can be restarted after sampling if clinically indicated to control blasts prior to the start of study treatment markers. 7. For patients with R/R NHL and R/R MM: * Absolute Neutrophil count \< 1.0 x 109/L * Platelets count \< 50 x 109/ L * Hemoglobin \< 8 g/dl 8. Autologous stem cell transplant within 3 months before the first dose of study treatment. 9. Patients who have undergone a prior allogeneic stem cell transplant before the first dose of study treatment. 10. History of or current interstitial lung disease or pneumonitis grade ≥ 2. 11. Impaired hepatic and renal function defined as: * Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 1.5 x upper limit of normal (ULN) * Bilirubin \>1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin) * Creatinine clearance \<50 mL/min (calculated using Cockroft-Gault formula, or measured). 12. Lipase \>1.5 x ULN or serum amylase \>1.5 x ULN and no history of pancreatitis. 13. Increased cardiac troponin above the manufacturer's 99th percentile upper reference limit for local assay at screening Other protocol-defined inclusion/exclusion criteria may apply

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Novartis Investigative Site

    Ghent, 9000, Belgium

  • Novartis Investigative Site

    HUS, FIN-00029, Finland

  • Novartis Investigative Site

    Hong Kong, Hong Kong

  • Novartis Investigative Site

    Tel Aviv, 6423906, Israel

  • Novartis Investigative Site

    Rozzano, MI, 20089, Italy

  • Novartis Investigative Site

    Sunto Gun, Shizuoka, 411 8777, Japan

  • Novartis Investigative Site

    Seoul, 03080, South Korea

  • Novartis Investigative Site

    Santander, Cantabria, 39008, Spain

  • Uni of TX MD Anderson Cancer Cntr UT MD Anderson Cancer Ctr

    Houston, Texas, 77030, United States

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Other studies related to the condition(s) this trial covers.