A Study of ARC-02 in B-cell NHL
Purpose
This study is to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamic (PD), and preliminary efficacy of ARC-02.
Condition
- B-cell Non Hodgkin Lymphoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Part A Dose Escalation: ARC-02 Monotherapy |
Participants will receive ARC-02 at multiple dose levels on Day 1 of each cycle until disease progression or unacceptable toxicity. |
|
|
Experimental Part A Dose Expansion: ARC-02 Monotherapy |
Participants will receive ARC-02 at a dose determined in Part A Dose Escalation on Day 1 of each cycle until disease progression or unacceptable toxicity. |
|
|
Experimental Part B Dose Escalation: ARC-02 in Combination with Rituximab |
Participants will receive ARC-02 at multiple dose levels on Day 1 of each cycle at multiple dose levels in combination with rituximab until disease progression or unacceptable toxicity. |
|
|
Experimental Part B Dose Expansion: ARC-02 in Combination with Rituximab |
Participants will receive ARC-02 at a dose determined in Part B Dose Escalation on Day 1 of each cycle in combination with rituximab until disease progression or unacceptable toxicity. |
|
Recruiting Locations
Start Cala
Los Angeles, California 90025
Los Angeles, California 90025
Summit Cancer Centers - North Spokane
Spokane, Washington 99208
Spokane, Washington 99208
More Details
- Status
- Recruiting
- Sponsor
- Taiho Oncology, Inc.