Study CP-MGC018-02 is a study of vobramitamab duocarmazine (MGC018) in combination with lorigerlimab (MGD019). The study is designed to characterize safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics, and preliminary antitumor activity. Participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors including, but not limited to, metastatic castration-resistant prostate cancer (mCRPC), melanoma, pancreatic cancer, hepatocellular carcinoma (HCC), ovarian cancer, and renal cell carcinoma (RCC) will be enrolled. Vobramitamab duocarmazine and lorigerlimab are administered separately on Day 1 of every 4-week (28-day) cycle at the assigned dose for each cohort. Participants who do not meet criteria for study drug discontinuation may receive study drugs for up to 2 years. Tumor assessments are performed every 8 weeks (± 7 days) for the initial 6 months on study drugs, then every 12 weeks (± 21 days) until progressive disease (PD). Participants will be followed for safety throughout the study. .
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Vobramitamab duocarmazine is an antibody drug conjugate (ADC) targeted against B7-H3.
Lorigerlimab is a bispecific DART® molecule that binds PD-1 and CTLA-4.
University of California, Los Angeles
Los Angeles, California, United States
University of California, San Francisco
San Francisco, California, United States
Florida Cancer Specialists and Research Institute
Sarasota, Florida, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Weill Cornell Medicine
New York, New York, United States
Carolina BioOncology
Huntersville, North Carolina, United States
Stephenson Cancer Center, The University of Oklahoma
Oklahoma City, Oklahoma, United States
University of Pittsburgh Medical Center, Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, United States
Number of participants with adverse events (AEs)
Time frame: Up to 2 years
Number of participants with serious adverse events (SAEs)
Time frame: Up to 2 years
Number of participants with AEs leading to study treatment discontinuation
Time frame: Up to 2 years
Mean maximum observed concentration (Cmax) of vobramitamab duocarmazine
Peak concentration of vobramitamab duocarmazine
Time frame: Throughout the study, up to 2 years
Mean maximum observed concentration (Cmax) of lorigerlimab
Peak concentration of lorigerlimab
Time frame: Throughout the study, up to 2 years
Mean time to maximum concentration (Tmax) of vobramitamab duocarmazine
Time at which peak concentration of vobramitamab duocarmazine is observed
Time frame: Throughout the study, up to 2 years
Mean time to maximum concentration (Tmax) of lorigerlimab
Time at which peak concentration of lorigerlimab is observed
Time frame: Throughout the study, up to 2 years
Mean area under the concentration-time curve during the dosing interval (AUCtau) of vobramitamab duocarmazine
Concentration of vobramitamab duocarmazine in the bloodstream during the 28-day dosing interval after dose administration
Time frame: Throughout the study, up to 2 years
Mean area under the concentration-time curve during the dosing interval (AUCtau) of lorigerlimab
Concentration of lorigerlimab in the bloodstream during the 28-day dosing interval after dose administration
Time frame: Throughout the study, up to 2 years
Mean trough concentration of vobramitamab duocarmazine
Concentration of vobramitamab duocarmazine at the end of a dosing interval
Time frame: Day 1 of each cycle (every 4 weeks) up to 2 years.
Mean trough concentration of lorigerlimab
Concentration of lorigerlimab at the end of a dosing interval
Time frame: Throughout the study, up to 2 years
Number of participants who develop anti-drug antibodies (ADA) to vobramitamab duocarmazine
Time frame: Throughout the study, up to 2 years
Number of participants who develop ADA to lorigerlimab
Time frame: Throughout the study, up to 2 years
Objective response rate (ORR)
Time frame: Assessed every 8 weeks for the first 6 months, then every 12 weeks for up to 2 years.
Median progression free survival (PFS)
PFS is defined as the time from the first dose date to the date of first documented PD or death from any cause, whichever occurs first.
Time frame: Assessed every 8 weeks for the first 6 months, then every 12 weeks. Survival status is assessed approximately every 12 weeks after the last dose of study treatment until withdrawal of consent, lost to follow up, death, or end of the study, up to 2 years.
Median duration of response (DoR)
DoR is defined as the time from the date of initial response (CR or PR) to the date of first documented PD or death from any cause, whichever occurs first.
Time frame: Assessed every 8 weeks for the first 6 months, then every 12 weeks for up to 2 years.
Median overall survival (OS)
OS is defined as the time from the first dose date to the date of death from any cause.
Time frame: Survival status is assessed approximately every 12 weeks after the last dose of study treatment until withdrawal of consent, lost to follow up, death, or end of the study, up to 2 years
Median radiographic PFS (rPFS) for mCRPC
rPFS is defined as the time from the first dose of study drug to the first occurrence of radiographic PD of soft tissue lesions using RECIST v1.1, or appearance of ≥ 2 new bone lesions, or death from any cause
Time frame: Assessed every 8 weeks for the first 6 months, then every 12 weeks for up to 2 years.
Prostate-specific antigen (PSA) response rate for mCRPC
PSA response is defined as ≥ 50% decline from baseline in PSA with confirmation at least 3 weeks later.
Time frame: PSA is assessed every 4 weeks, up to 2 years while on treatment, then every 12 weeks for up to an additional 2 years in follow-up.
Best PSA percent change from baseline for mCRPC
Time frame: PSA is assessed every 4 weeks, up to 2 years while on treatment, then every 12 weeks for up to an additional 2 years in follow-up.
Median time to PSA progression for mCRPC
PSA progression is defined as an increase that is ≥ 25% and ≥ 2 ng/mL the baseline or lowest value observed, and which confirmed by a second value at least 3 weeks later.
Time frame: PSA is assessed every 4 weeks, up to 2 years while on treatment, then every 12 weeks for up to an additional 2 years in follow-up.
Median duration of PSA response for mCRPC
DoR of PSA is defined as the time from the date of initial PSA response to the date of first documented PSA progression or death from any cause, whichever occurs first.
Time frame: PSA is assessed every 4 weeks, up to 2 years while on treatment, then every 12 weeks for up to an additional 2 years in follow-up.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.