This study is to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamic (PD), and preliminary efficacy of ARC-02.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
Dose Escalation: Number of Participants with Dose-Limiting Toxicities (DLTs)
Time frame: Up to 5 years
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: ORR as Assessed by the Investigator
Time frame: Up to 5 years
Dose Expansion: Number of Participants with TEAEs and SAEs
Time frame: Up to 5 years
Dose Escalation and Expansion: Time to Response (TTR)
Time frame: Up to 5 years
Dose Escalation and Expansion: Duration of Response (DOR)
Time frame: Up to 5 years
Dose Escalation and Expansion: Progression-free Survival (PFS)
Time frame: Up to 5 years
Dose Escalation and Expansion: Maximum Observed Plasma Concentration (Cmax)
This will be assessed for antibody conjugated monomethyl auristatin E (acMMAE), total anti-CD79b antibody and free monomethyl auristatin E (MMAE).
Time frame: Up to 5 years
Dose Escalation and Expansion: Apparent Elimination Half-Life (t½)
This will be assessed for acMMAE, total anti-CD79b antibody and free MMAE.
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Start Cala
Los Angeles, California, United States
RECRUITINGNorton Cancer Institute
Louisville, Kentucky, United States
NOT_YET_RECRUITINGNYU Langone
New York, New York, United States
NOT_YET_RECRUITINGLevine Cancer Institute
Charlotte, North Carolina, United States
NOT_YET_RECRUITINGMassey Cancer Center
Richmond, Virginia, United States
NOT_YET_RECRUITINGSummit Cancer Centers - North Spokane
Spokane, Washington, United States
RECRUITINGFroedtert & Medical College of Wisconsin
Milwaukee, Wisconsin, United States
NOT_YET_RECRUITINGMonash Health
Clayton, Australia
NOT_YET_RECRUITINGAustin Health
Melbourne, Australia
NOT_YET_RECRUITINGLinear Clinical Research
Nedlands, Australia
NOT_YET_RECRUITING...and 19 more locations
Time frame: Up to 5 years
Dose Escalation and Expansion: AUC From Time 0 to Infinity (AUC0-inf)
This will be assessed for acMMAE, total anti-CD79b antibody and free MMAE.
Time frame: Up to 5 years
Dose Escalation and Expansion: AUC to the Last Measurable Concentration (AUC(0-τ)
This will be assessed for acMMAE, total anti-CD79b antibody and free MMAE.
Time frame: Up to 5 years
Dose Escalation and Expansion: Number of Participants with Antidrug Antibodies (ADA) and Neutralizing Antibodies (Nab)
Time frame: Up to 5 years