A Study to Evaluate Safety, Tolerability, Pharmacokinetics (PK), and Clinical Activity of ARC-02 in Adult Participants With B-cell Non-Hodgkins Lymphoma (NHL)
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Taiho Oncology, Inc.
- Enrollment
- 140
- Locations
- 29
- Primary Endpoint
- Dose Escalation: Number of Participants with Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Study Overview
Brief Summary
This study is to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamic (PD), and preliminary efficacy of ARC-02.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- 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:
- •Follicular lymphoma (FL), Grades 1 through 3B
- •Marginal zone lymphoma (MZL)
- •Mantle cell lymphoma (MCL)
- •Diffuse large B-cell lymphoma (DLBCL)
- •Other B-cell NHL
- •Measurable disease.
- •Received at least 2 prior lines of systemic therapies and not eligible to receive additional standard of care therapies.
- •An Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2 at screening.
- •Adequate organ function within 3 days of the first dose of study intervention.
- •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.
- •Grade > 1 neuropathy
- •History of interstitial lung disease (ILD)/pneumonitis requiring treatment or any evidence of active ILD/pneumonitis.
- •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.
- •Any live or live-attenuated vaccine within 28 days before the first dose of the study intervention.
- •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.
Arms & Interventions
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.
Intervention: ARC-02 (Drug)
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.
Intervention: ARC-02 (Drug)
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.
Intervention: ARC-02 (Drug)
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.
Intervention: ARC-02 (Drug)
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.
Intervention: Rituximab (Drug)
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.
Intervention: Rituximab (Drug)
Outcomes
Primary Outcomes
Dose Escalation: Number of Participants with Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame: Up to 5 years
Dose Expansion: Objective Response Rate (ORR) as Assessed by the Investigator
Time Frame: Up to 5 years
Dose Escalation: Number of Participants with Dose-Limiting Toxicities (DLTs)
Time Frame: Up to 5 years
Secondary Outcomes
- 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)
- Dose Escalation and Expansion: Apparent Elimination Half-Life (t½)(Up to 5 years)
- Dose Escalation and Expansion: AUC From Time 0 to Infinity (AUC0-inf)(Up to 5 years)
- Dose Escalation and Expansion: AUC to the Last Measurable Concentration (AUC(0-τ)(Up to 5 years)
- Dose Escalation and Expansion: Number of Participants with Antidrug Antibodies (ADA) and Neutralizing Antibodies (Nab)(Up to 5 years)