A Dose Finding Study Followed by a Safety and Efficacy Study for Patients With Multiple Myeloma or Lymphoma

A Phase 1, Open-Label Safety, Pharmacokinetic and Efficacy Study of TAS4464 in Patients With Multiple Myeloma or Lymphoma

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02978235

Enrollment

Registered

2016-11-30

Start date

2017-03-01

Completion date

2018-02-01

Last updated

2024-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma, NonHodgkin Lymphoma

Keywords

Multiple Myeloma, Relapsed/Refractory, Lymphoma, Non-Hodgkin Lymphoma, Diffuse Large B-Cell Lymphoma, DLBCL, Mantle Cell Lymphoma, MCL, Peripheral T-Cell Lymphoma, PTCL, TAS4464, NEDD8, NAE inhibitor, Neoplasms, Hematologic Diseases, Myeloma

Brief summary

The Phase 1 portion of this study will determine the safety of TAS4464 and the most appropriate dose for patients with Multiple Myeloma or Lymphoma.

Detailed description

The trial was put on Clinical Hold prior to Phase 2 due to cases of drug induced liver injury meeting the criteria for Hy's Law. Background and Rationale: • TAS4464 is an investigational NEDD8 activating enzyme (NAE) inhibitor, a compound which may affect cancer cell growth and survival. Thus, TAS4464 may help in the treatment of cancer. Phase 1: Primary: * To investigate the safety and tolerability of TAS4464 * To identify a tolerated dose of TAS4464 Secondary: * To investigate the preliminary efficacy of TAS4464 * To investigate the pharmacokinetics (PK) and the pharmacogenomics (PGx) of TAS4464 * To investigate the pharmacodynamics of TAS4464

Interventions

DRUGTAS4464

Intravenous (IV) Infusion

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Provide written informed consent 2. Women of child-bearing potential must have a negative pregnancy test Multiple Myeloma: Confirmed diagnosis of Multiple Myeloma with measurable disease, having been treated with at least two prior lines of therapy. Lymphoma: Confirmed diagnosis of Non-Hodgkin Lymphoma with measurable disease, having been treated with at least one anthracycline-based therapy, with relapse or progression since the last treatment received.

Exclusion criteria

1. Any of the following treatments, within the specified time frame, prior to the first dose of TAS4464: 1. Major surgery within 28 days 2. Radiation/chemotherapy within 21 days 3. Monoclonal antibodies within 28 days 4. Corticosteroid administration \>20 mg/day of prednisone or equivalent within 14 days 5. Proteasome inhibitors within 14 days 6. Immunomodulatory agents within 7 days 7. Stem cell transplant within 3 months 8. Current immunosuppressive treatment for graft versus host disease 9. Current use of an investigational agent 2. Active graft versus host disease 3. Known serious illness or medical condition 4. Prior treatment with TAS4464 or known hypersensitivity to any of its inactive ingredients or drugs similar in class 5. Pregnant or breast-feeding female

Design outcomes

Primary

Measure	Time frame
Number of patients experiencing any dose-limiting toxicities, during dose escalation period, to determine maximum tolerated dose of TAS4464, using NCI CTCAE criteria, laboratory testing, performance status assessments, and other routine visit procedures	Completion of Cycle 1 (28 days)
Efficacy of TAS4464, defined as Objective Response Rate (ORR) per IWG criteria (NHL) and IMWG criteria (MM). This will take into consideration routine assessments including: imaging scans, physical exams, blood tests, urine tests and biopsy results	Up to 5 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026