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

JRCT ID: jRCT2041210091

Registered date:28/10/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: non-Hodgkin lymphoma, acute myeloid leukemia, multiple myeloma
• Date of first enrollment: 12/10/2021
• Target sample size: 15
• Countries of recruitment: Commonwealth of Australia,Japan,Kingdom of Belgium,Japan,Kingdom of Spain,Japan,Federal Republic of Germany,Japan,Republic of Finland,Japan,State of Israel,Japan,United States of America,Japan,Republic of Korea,Japan,Republic of Singapore,Japan,Republic of Italy,Japan
• Study type: Interventional

Intervention(s)

VOB560 and MIK665 will be administered. In escalation part, increasing doses of VOB560 and MIK665 are given to small groups of patients to identify the safest dose of the combination.
In the expansion part, the identified safest doses from the escalation part of the study will be tested.

Outcome(s)

• Primary Outcome: Safety and tolerability

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Diagnosis of one of the following hematologic malignancies:
- relapsed and/or refractory patients with non-Hodgkin lymphoma who have received >= 2 lines of therapy and who are not eligible for treatment with other regimens known to provide clinical benefit 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 3 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. With measurable disease per the IMWG response criteria, as indicated by one or more of the following:
-Serum M-protein >= 0.5 g/dL, Urine M-protein >= 200 mg/24 hours
-For Patients who do not meet 1 of the 2 prior criteria:
Serum Free Light Chain (sFLC) >= 10 mg/dL (>= 100 mg/L) and an abnormal sFLC ratio (< 0.26 or > 1.65) as per the IMWG response criteria
In the dose expansion, at least 10 MM patients with documented 1q gain will be included.
- 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 who have failed all conventional therapy 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).

Exclude criteria

- 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
- 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.

Related Information

• Primary Sponsor: Hirano Takamitsu
• Secondary ID(s): NCT04702425