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Protein Blocker

VOB560 + MIK665 for Blood Cancer

Phase 1
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Diagnosis of relapsed and/or refractory multiple myeloma (MM) treated with at least 2 prior regimens, including an IMiD, a 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at month 18
Awards & highlights

Study Summary

This trialwill test if VOB560 and MIK665 can safely be given together and if it can help treat NHL, MM or AML.

Who is the study for?
This trial is for adults with certain blood cancers (Non-Hodgkin lymphoma, Multiple Myeloma, or Acute Myeloid Leukemia) that have come back or didn't respond to treatment. They should be fairly active (ECOG ≤2), have measurable disease, and must have tried multiple treatments already. People can't join if they've had severe heart issues, very low blood counts, serious allergies to study drugs' ingredients, recent other cancer therapies, or are suitable for standard re-induction chemotherapy.Check my eligibility
What is being tested?
The trial tests a combination of two new drugs: VOB560 and MIK665. These drugs block proteins BCL2 and MCL1 that help cancer cells avoid death. The goal is to find safe doses and see if the drug combo helps patients by causing cancer cells to die off.See study design
What are the potential side effects?
While specific side effects aren't listed here, similar medications often cause symptoms like nausea, fatigue, risk of infection due to low blood cell counts; potential heart problems could also arise given the exclusion criteria related to cardiac health.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am willing and able to undergo multiple bone marrow tests as required.
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My multiple myeloma has returned or didn't respond to treatment, and I've tried at least 2 types of treatment including IMiD, a proteasome inhibitor, and anti-CD38 antibody.
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I can take care of myself but might not be able to do heavy physical work.
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My non-Hodgkin lymphoma has returned or didn't respond to treatment, and I have a measurable tumor.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at month 18
This trial's timeline: 3 weeks for screening, Varies for treatment, and at month 18 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose intensities
Frequency of dose interruptions
Frequency of dose reductions
+2 more
Secondary outcome measures
Apparent volume of distribution (Vz) of MIK665
Apparent volume of distribution (Vz) of VOB560
Area Under Curve (AUC) of MIK665
+12 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: VOB560-MIK665 - Part 2dExperimental Treatment2 Interventions
Part 2d - Patients with relapsed/refractory acute myeloid leukemia venetoclax naive patients administered VOB560 and MIK665 as an intravenous (IV) infusion.
Group II: VOB560-MIK665 - Part 2cExperimental Treatment2 Interventions
Part 2c - Patients with relapsed/refractory acute myeloid leukemia venetoclax refractory or insensitive with at least 6 patients M5 as proposed by French-American-British (FAB) group, based on the observation that venetoclax resistance in AML M5 can be caused by up-regulation of MCL1 administered VOB560 and MIK665 as an intravenous (IV) infusion.
Group III: VOB560-MIK665 - Part 2bExperimental Treatment2 Interventions
Part 2b - Patients with relapsed/refractory non-Hodgkin lymphoma with at least 10 patients with double-hit (DH) lymphoma, based on the overall bad prognosis and limited therapeutic options for patients with DH NHL administered VOB560 and MIK665 as an intravenous (IV) infusion.
Group IV: VOB560-MIK665 - Part 2aExperimental Treatment2 Interventions
Part 2a - Patients with relapsed/refractory multiple myeloma with at least 10 patients with 1q gain cytogenetic abnormality and 10 patients with high risk R/R MM as defined in (Sonneveld et al 2016) administered VOB560 and MIK665 as an intravenous (IV) infusion.
Group V: VOB560-MIK665 - Part 1bExperimental Treatment2 Interventions
Part 1b - Patients with relapsed/refractory acute myeloid leukemia administered VOB560 and MIK665 as an intravenous (IV) infusion.
Group VI: VOB560-MIK665 - Part 1aExperimental Treatment2 Interventions
Part 1a - Patients with relapsed/refractory non-Hodgkin lymphoma and relapsed/refractory multiple myeloma administered VOB560 and MIK665 as an intravenous (IV) infusion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MIK665
2017
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,313 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the goals of this clinical research?

"The primary goal of this clinical trial is to assess the incidence of dose-limiting toxicities (DLTs) during the first cycle of treatment with VOB560 and MIK665 in combination. Secondary outcomes include apparent volume of distribution (Vz) of VOB560, overall response rate (ORR), and area under curve (AUC) of MIK665."

Answered by AI

Are there harmful effects to taking VOB560-MIK665 - Part 2a?

"This medication, VOB560-MIK665 - Part 2a, is still in Phase 1 of clinical trials. This limits the available data regarding both its safety and efficacy, thus it was given a score of 1."

Answered by AI

How many candidates are being enrolled in this study?

"That is correct. The website clinicaltrials.gov has the most recent information about this study, which began recruiting on 6/23/2021. As of 10/21/2022, the trial is still recruiting and looking for 170 participants from 1 location."

Answered by AI

Are there any available positions for patients in this trial?

"The trial is currently active and looking for participants, with the most recent update on 10/21/2022. 170 patients are needed from 1 medical site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
VOB560-MIK665 Combination First in Human Trial in Patients With Hematological Malignancies (Relapsed/Refractory Non-Hodgkin Lymphoma, Relapsed/Refractory Acute Myeloid Leukemia, or Relapsed/Refractory Multiple Myeloma)
2021. "VOB560-MIK665 Combination First in Human Trial in Patients With Hematological Malignancies (Relapsed/Refractory Non-Hodgkin Lymphoma, Relapsed/Refractory Acute Myeloid Leukemia, or Relapsed/Refractory Multiple Myeloma)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04702425.
~2 spots leftby Jun 2024
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