Non-Hodgkin Lymphoma (NHL)Phase 1NCT04702425
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)
A Phase 1 study testing VOB560 and MIK665 in people with Non-Hodgkin Lymphoma (NHL) and Acute Myeloid Leukemia (AML), run by Novartis Pharmaceuticals at 9 sites in 9 countries.
Trial summary
The purpose of the study was to identify doses and schedules of VOB560 and MIK665 that can be safely given and to learn if the combination can have possible benefits for patients with Non-Hodgkin lymphoma (NHL), Multiple Myeloma (MM) or Acute Myeloid Leukemia (AML). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin Lymphoma (NHL), Acute Myeloid Leukemia (AML), Multiple Myeloma (MM)
- What is being tested?
- VOB560 and MIK665
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 9 sitesin 9 countries
- Study dates
- 23 Jun 2021to 23 Jul 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- History of severe hypersensitivity reactions to any ingredient of study treatment and/or their excipients.
- 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.
- High-risk patients for Tumor Lysis Syndrome according to Cairo et al 2010 criteria or local guidelines.
- 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:
- Concomitant clinically significant cardiac arrhythmias, e.g. sustained ventricular tachycardia, and clinically significant second- or third-degree AV block without a pacemaker
- 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
Show all 28Show fewer
- 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
- Resting QTcF ≥450 msec (male) or ≥460 msec (female) at pre-treatment
- Use of agents known to prolong the QT interval unless it can be permanently discontinued for the duration of study.
- Abnormal echocardiogram (ECHO) or multi-gated acquisition scan (MUGA) at baseline (left ventricular ejection fraction [LVEF] <50%)
- Symptomatic congestive heart failure (New York Heart Association ≥ 3)
- Findings observed in the baseline cardiac MRI that might reflect an increased risk for cardiac adverse events.
- 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.
- 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.
- 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
- Autologous stem cell transplant within 3 months before the first dose of study treatment.
- Patients who have undergone a prior allogeneic stem cell transplant before the first dose of study treatment.
- History of or current interstitial lung disease or pneumonitis grade ≥ 2.
- 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).
- Lipase >1.5 x ULN or serum amylase >1.5 x ULN and no history of pancreatitis.
- 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
Trial locations and contacts
9 sites in 9 countries.
9 sites in 9 countries
United States1 site
Uni of TX MD Anderson Cancer Cntr UT MD Anderson Cancer Ctr
Houston, Texas, 77030
About this study
Official title: A Phase Ib, Multicenter Study of VOB560 in Combination With MIK665 in Patients With Relapsed/Refractory Non-Hodgkin Lymphoma, Relapsed/Refractory Acute Myeloid Leukemia, or Relapsed/Refractory Multiple Myeloma.
The purpose of the study was to identify doses and schedules of VOB560 and MIK665 that can be safely given and to learn if the combination can have possible benefits for patients with Non-Hodgkin lymphoma (NHL), Multiple Myeloma (MM) or Acute Myeloid Leukemia (AML).
VOB560 and MIK665 are selective and potent blockers respectively of the B-cell lymphoma 2 (BCL2) protein and of the myeloid cell leukaemia 1 (MCL1) protein, proteins that may protect tumor cells from undergoing cell death. VOB560 and MIK665 are designed to block the functions of the BCL2 and MCL1 proteins, so that the tumor cells that rely on these proteins undergo cell death.
Preclinical data suggest that concomitant treatment with VOB560 in combination with MIK665 induces robust anti-tumor activity.
Read the detailed description
This was an open-label, non-randomized multi-center phase Ib dose-escalation study with dose expansion arms in four different patient populations. Patients received VOB560 in combination with MIK665 in a once a week (QW) schedule over 21 days cycle. Less frequent dosing schedules could be explored based on emerging data. Patients were to be treated until disease progression or unacceptable toxicities occurred.
The study included a dose escalation part (Part 1) and a dose expansion part (Part 2).
The following escalation arms were planned:
- Arm A: relapsed/refractory (R/R) NHL and R/R MM
- Arm B: R/R AML There were 4 expansion arms planned. However, the expansion part of the study was not initiated.
- Being tested
- VOB560, MIK665
- Keywords
- Phase Ib, BHLRM, VOB560, MIK665, NHL, AML, MM, Bcl2, Mcl1
- Medical subject headings
- Lymphoma, Non-Hodgkin, Leukemia, Myeloid, Acute, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VOB560Drug
Also called S65487
Powder for concentrate for solution for infusion
MIK665Drug
Also called S64315
Concentrate for solution for infusion
| Study group | Role | What they receive |
|---|---|---|
| VOB560-MIK665 - Part 1a | Experimental | Part 1a - Patients with relapsed/refractory non-Hodgkin lymphoma and relapsed/refractory multiple myeloma administered VOB560 and MIK665 as an intravenous (IV) infusion. Receives: Drug: VOB560; Drug: MIK665 |
| VOB560-MIK665 - Part 1b | Experimental | Part 1b - Patients with relapsed/refractory acute myeloid leukemia administered VOB560 and MIK665 as an intravenous (IV) infusion. Receives: Drug: VOB560; Drug: MIK665 |
| VOB560-MIK665 - Part 2a | Experimental | 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. Receives: Drug: VOB560; Drug: MIK665 |
| VOB560-MIK665 - Part 2b | Experimental | 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. Receives: Drug: VOB560; Drug: MIK665 |
| VOB560-MIK665 - Part 2c | Experimental | 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. Receives: Drug: VOB560; Drug: MIK665 |
| VOB560-MIK665 - Part 2d | Experimental | Part 2d - Patients with relapsed/refractory acute myeloid leukemia venetoclax naive patients administered VOB560 and MIK665 as an intravenous (IV) infusion. Receives: Drug: VOB560; Drug: MIK665 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of AEs and SAEs, including changes in lab values, vital signs, and ECGs
Month 18 is assumed to be study end
Measured: at month 18
Incidence of Dose Limiting Toxicities (DLTs) during the first cycle of treatment with VOB560 and MIK665 in combination
Month 18 is assumed to be study end
Measured: at month 18
Frequency of dose interruptions
Month 18 is assumed to be study end
Measured: at month 18
Frequency of dose reductions
Month 18 is assumed to be study end
Measured: at month 18
Dose intensities
Month 18 is assumed to be study end
Measured: at month 18
Secondary outcomes (15)
Overall Response Rate (ORR)
Month 18 is assumed to be study end As per European LeukemiaNet (ELN) 2017 for relapse/refractory (R/R) AML As per International Myeloma Working Group (IMWG) 2016 for R/R MM As per Lugano Classification 2014 for R/R NHL
Measured: at month 18
Complete Response (CR) rate (and rate of CR or sCR in R/R MM)
Month 18 is assumed to be study end As per European LeukemiaNet (ELN) 2017 for relapse/refractory (R/R) AML As per International Myeloma Working Group (IMWG) 2016 for R/R MM As per Lugano Classification 2014 for R/R NHL
Measured: at month 18
Best Overall Response (BOR)
Month 18 is assumed to be study end As per European LeukemiaNet (ELN) 2017 for relapse/refractory (R/R) AML As per International Myeloma Working Group (IMWG) 2016 for R/R MM As per Lugano Classification 2014 for R/R NHL
Measured: at month 18
Duration Of Response (DOR)
Month 18 is assumed to be study end Month 18 is assumed to be study end As per European LeukemiaNet (ELN) 2017 for relapse/refractory (R/R) AML As per International Myeloma Working Group (IMWG) 2016 for R/R MM As per Lugano Classification 2014 for R/R NHL
Measured: at month 18
Progression Free Survival (PFS)
Month 18 is assumed to be study end As per European LeukemiaNet (ELN) 2017 for relapse/refractory (R/R) AML As per International Myeloma Working Group (IMWG) 2016 for R/R MM As per Lugano Classification 2014 for R/R NHL
Measured: at month 18
Area Under Curve (AUC) of VOB560
PK parameter
Measured: At the end of Cycle 6 (each cycle is 21 days)
Maximum Plasma Concentration (Cmax) ok VOB560
PK parameter
Measured: At the end of Cycle 6 (each cycle is 21 days)
Terminal elimination half-life (T1/2) of VOB560
PK parameter
Measured: At the end of Cycle 6 (each cycle is 21 days)
Clearance (CL) of VOB560
PK parameter
Measured: At the end of Cycle 6 (each cycle is 21 days)
Apparent volume of distribution (Vz) of VOB560
PK parameter
Measured: At the end of Cycle 6 (each cycle is 21 days)
Area Under Curve (AUC) of MIK665
PK parameter
Measured: At the end of Cycle 6 (each cycle is 21 days)
Maximum Plasma Concentration (Cmax) ok MIK665
PK parameter
Measured: At the end of Cycle 6 (each cycle is 21 days)
Terminal elimination half-life (T1/2) of MIK665
PK parameter
Measured: At the end of Cycle 6 (each cycle is 21 days)
Clearance (CL) of MIK665
PK parameter
Measured: At the end of Cycle 6 (each cycle is 21 days)
Apparent volume of distribution (Vz) of MIK665
PK parameter
Measured: At the end of Cycle 6 (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start23 Jun 2021
- Primary completion23 Jul 2024
- Study completion23 Jul 2024
Why it stopped: Business reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin Lymphoma (NHL)Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04702425
- Sponsor's protocol ID
- CVOB560A12101
- Other IDs
- 2020-004691-18
- Status last verified
- Oct 2025
- First submitted
- 2 Dec 2020
- Last updated
- 10 Oct 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Multicenter Study of VOB560 in Combination With MIK665 in Patients With Relapsed/Refractory Non-Hodgkin Lymphoma, Relapsed/Refractory Acute Myeloid Leukemia, or Relapsed/Refractory Multiple Myeloma.
- ClinicalTrials.gov ID
- NCT04702425
- Acronym / sponsor ID
- CVOB560A12101
- Keywords
- Phase Ib, BHLRM, VOB560, MIK665, NHL, AML, MM, Bcl2, Mcl1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business reasons
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2021 (actual)
- Primary completion
- 23 Jul 2024 (actual)
- Study completion
- 23 Jul 2024 (actual)
- First posted
- 8 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study was to identify doses and schedules of VOB560 and MIK665 that can be safely given and to learn if the combination can have possible benefits for patients with Non-Hodgkin lymphoma (NHL), Multiple Myeloma (MM) or Acute Myeloid Leukemia (AML).
VOB560 and MIK665 are selective and potent blockers respectively of the B-cell lymphoma 2 (BCL2) protein and of the myeloid cell leukaemia 1 (MCL1) protein, proteins that may protect tumor cells from undergoing cell death. VOB560 and MIK665 are designed to block the functions of the BCL2 and MCL1 proteins, so that the tumor cells that rely on these proteins undergo cell death.
Preclinical data suggest that concomitant treatment with VOB560 in combination with MIK665 induces robust anti-tumor activity.
Detailed description
This was an open-label, non-randomized multi-center phase Ib dose-escalation study with dose expansion arms in four different patient populations. Patients received VOB560 in combination with MIK665 in a once a week (QW) schedule over 21 days cycle. Less frequent dosing schedules could be explored based on emerging data. Patients were to be treated until disease progression or unacceptable toxicities occurred.
The study included a dose escalation part (Part 1) and a dose expansion part (Part 2).
The following escalation arms were planned:
- Arm A: relapsed/refractory (R/R) NHL and R/R MM
- Arm B: R/R AML There were 4 expansion arms planned. However, the expansion part of the study was not initiated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| VOB560-MIK665 - Part 1a | Experimental | Drug: VOB560, Drug: MIK665Part 1a - Patients with relapsed/refractory non-Hodgkin lymphoma and relapsed/refractory multiple myeloma administered VOB560 and MIK665 as an intravenous (IV) infusion. |
| VOB560-MIK665 - Part 1b | Experimental | Drug: VOB560, Drug: MIK665Part 1b - Patients with relapsed/refractory acute myeloid leukemia administered VOB560 and MIK665 as an intravenous (IV) infusion. |
| VOB560-MIK665 - Part 2a | Experimental | Drug: VOB560, Drug: MIK665Part 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. |
| VOB560-MIK665 - Part 2b | Experimental | Drug: VOB560, Drug: MIK665Part 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. |
| VOB560-MIK665 - Part 2c | Experimental | Drug: VOB560, Drug: MIK665Part 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. |
| VOB560-MIK665 - Part 2d | Experimental | Drug: VOB560, Drug: MIK665Part 2d - Patients with relapsed/refractory acute myeloid leukemia venetoclax naive patients administered VOB560 and MIK665 as an intravenous (IV) infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of one of the following hematologic malignancies:
- 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.
Key exclusion criteria (28 listed)
- History of severe hypersensitivity reactions to any ingredient of study treatment and/or their excipients.
- 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.
- High-risk patients for Tumor Lysis Syndrome according to Cairo et al 2010 criteria or local guidelines.
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VOB560Also: S65487Powder for concentrate for solution for infusion | Drug | VOB560-MIK665 - Part 1a, VOB560-MIK665 - Part 1b, VOB560-MIK665 - Part 2a, VOB560-MIK665 - Part 2b, VOB560-MIK665 - Part 2c, VOB560-MIK665 - Part 2d |
| MIK665Also: S64315Concentrate for solution for infusion | Drug | VOB560-MIK665 - Part 1a, VOB560-MIK665 - Part 1b, VOB560-MIK665 - Part 2a, VOB560-MIK665 - Part 2b, VOB560-MIK665 - Part 2c, VOB560-MIK665 - Part 2d |
Primary outcome
Incidence and severity of AEs and SAEs, including changes in lab values, vital signs, and ECGs
Time frame: at month 18
Month 18 is assumed to be study end
Incidence of Dose Limiting Toxicities (DLTs) during the first cycle of treatment with VOB560 and MIK665 in combination
Time frame: at month 18
Month 18 is assumed to be study end
Frequency of dose interruptions
Time frame: at month 18
Month 18 is assumed to be study end
Frequency of dose reductions
Time frame: at month 18
Month 18 is assumed to be study end
Dose intensities
Time frame: at month 18
Month 18 is assumed to be study end
15 secondary outcomes
Overall Response Rate (ORR)
Time frame: at month 18
Complete Response (CR) rate (and rate of CR or sCR in R/R MM)
Time frame: at month 18
Best Overall Response (BOR)
Time frame: at month 18
Duration Of Response (DOR)
Time frame: at month 18
Progression Free Survival (PFS)
Time frame: at month 18
Area Under Curve (AUC) of VOB560
Time frame: At the end of Cycle 6 (each cycle is 21 days)
Maximum Plasma Concentration (Cmax) ok VOB560
Time frame: At the end of Cycle 6 (each cycle is 21 days)
Terminal elimination half-life (T1/2) of VOB560
Time frame: At the end of Cycle 6 (each cycle is 21 days)
Clearance (CL) of VOB560
Time frame: At the end of Cycle 6 (each cycle is 21 days)
Apparent volume of distribution (Vz) of VOB560
Time frame: At the end of Cycle 6 (each cycle is 21 days)
Area Under Curve (AUC) of MIK665
Time frame: At the end of Cycle 6 (each cycle is 21 days)
Maximum Plasma Concentration (Cmax) ok MIK665
Time frame: At the end of Cycle 6 (each cycle is 21 days)
Terminal elimination half-life (T1/2) of MIK665
Time frame: At the end of Cycle 6 (each cycle is 21 days)
Clearance (CL) of MIK665
Time frame: At the end of Cycle 6 (each cycle is 21 days)
Apparent volume of distribution (Vz) of MIK665
Time frame: At the end of Cycle 6 (each cycle is 21 days)
Results and safety
The study was stopped early (reason given: Business reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2025.
- Study results on Novartis clinical trials results databaseLink provided by the sponsor.
- A Plain Language Trial Summary is available on www.novctrd.comLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VOB560 and MIK665 in people with Non-Hodgkin Lymphoma (NHL) and Acute Myeloid Leukemia (AML), run by Novartis Pharmaceuticals at 9 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Belgium, Finland, Hong Kong, Israel and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Business reasons). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of AEs and SAEs, including changes in lab values, vital signs, and ECGs (time frame: at month 18). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2025.