B-cell Non Hodgkin Lymphoma
Conditions
Keywords
Non-Hodgkin's Lymphomas, Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma, Waldenstroms Macroglobulinemia, Germinal Center B-cell, Activated B-Cell, NHL, DLBCL, MCL, FL, MZL, WM, GCB, ABC, Cancer, ARC-02
Brief summary
This study is to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamic (PD), and preliminary efficacy of ARC-02.
Interventions
DRUGARC-02
Intravenous (IV) infusion.
DRUGRituximab
IV infusion.
Sponsors
Taiho Oncology, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. A documented diagnosis of B-cell Non- Hodgkin Lymphoma (NHL) per 2016 World Health Organization criteria and disease requiring treatment: 1. Follicular lymphoma (FL), Grades 1 through 3B 2. Marginal zone lymphoma (MZL) 3. Mantle cell lymphoma (MCL) 4. Diffuse large B-cell lymphoma (DLBCL) 5. Other B-cell NHL 2. Measurable disease. 3. Received at least 2 prior lines of systemic therapies and not eligible to receive additional standard of care therapies. 4. An Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2 at screening. 5. Adequate organ function within 3 days of the first dose of study intervention. 6. A negative blood pregnancy test within 7 days prior to first dose of study intervention (for women of childbearing potential).
Exclusion criteria
1. Receiving an investigational product or participating in any other type of medical research judged not to be compatible with this study. 2. Grade \> 1 neuropathy 3. History of interstitial lung disease (ILD)/pneumonitis requiring treatment or any evidence of active ILD/pneumonitis. 4. Use of: 1. Chemotherapy, radiotherapy, small molecule, investigational, and biologic agents (including CD79b-directed agents) within 28 days (or at least 5 half-lives, whichever is shorter), prior to the first dose of the study intervention. 2. Any live or live-attenuated vaccine within 28 days before the first dose of the study intervention. 5. Ongoing clinically relevant toxicity from prior anticancer therapy that has not resolved to Grade ≤ 2 (neutropenia) or Grade ≤ 1 (thrombocytopenia or nonhematologic toxicities), with the exception of alopecia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose Escalation: Number of Participants with Dose-Limiting Toxicities (DLTs) | Up to 5 years |
| Dose Escalation: Number of Participants with Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Up to 5 years |
| Dose Expansion: Objective Response Rate (ORR) as Assessed by the Investigator | Up to 5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dose Escalation: ORR as Assessed by the Investigator | Up to 5 years | — |
| Dose Expansion: Number of Participants with TEAEs and SAEs | Up to 5 years | — |
| Dose Escalation and Expansion: Time to Response (TTR) | Up to 5 years | — |
| Dose Escalation and Expansion: Duration of Response (DOR) | Up to 5 years | — |
| Dose Escalation and Expansion: Progression-free Survival (PFS) | Up to 5 years | — |
| Dose Escalation and Expansion: Maximum Observed Plasma Concentration (Cmax) | Up to 5 years | This will be assessed for antibody conjugated monomethyl auristatin E (acMMAE), total anti-CD79b antibody and free monomethyl auristatin E (MMAE). |
| Dose Escalation and Expansion: Apparent Elimination Half-Life (t½) | Up to 5 years | This will be assessed for acMMAE, total anti-CD79b antibody and free MMAE. |
| Dose Escalation and Expansion: AUC From Time 0 to Infinity (AUC0-inf) | Up to 5 years | This will be assessed for acMMAE, total anti-CD79b antibody and free MMAE. |
| Dose Escalation and Expansion: AUC to the Last Measurable Concentration (AUC(0-τ) | Up to 5 years | This will be assessed for acMMAE, total anti-CD79b antibody and free MMAE. |
| Dose Escalation and Expansion: Number of Participants with Antidrug Antibodies (ADA) and Neutralizing Antibodies (Nab) | Up to 5 years | — |
Countries
Australia, France, Italy, Poland, Spain, United States
Contacts
CONTACTTaiho Oncology, Inc.
Outcome results
None listed