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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05293496
Other study ID # CP-MGC018-02
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date April 19, 2022
Est. completion date March 2026

Study information

Verified date June 2024
Source MacroGenics
Contact Global Trial Manager
Phone 301-251-5172
Email info@macrogenics.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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. .


Recruitment information / eligibility

Status Recruiting
Enrollment 278
Est. completion date March 2026
Est. primary completion date March 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 1. Ability to provide and document informed consent and willing and able to comply with all study procedures. - Participants diagnosed with advanced solid tumors including but not limited to metastatic castration-resistant prostate cancer, melanoma, pancreatic cancer, hepatocellular carcinoma, ovarian cancer and renal cell carcinoma. - Participants have received approved therapies according to their diagnosis. - Participants must have an available tumor tissue sample. A fresh tumor biopsy may be performed if no archival sample is available. - Eastern Cooperative Oncology Group performance status of less than or equal to 2. - Life expectancy of at least 12 weeks. - Evidence of measurable tumor for evaluation - Acceptable end organ function according to laboratory results. - Patients must agree to use highly-effective contraception during the study, and not donate sperm or ova. Exclusion Criteria: - Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures. - Another malignancy that required treatment within the past 2 years. Participants who have had curative therapy for non-melanomatous skin cancer, localized prostate cancer (Gleason score < 6), or carcinoma in situ are eligible for the study. - Active viral, bacterial, or fungal infection requiring systemic treatment within 1 week of initiation of study drug. Participants are eligible after SARS CoV 2-related symptoms have fully recovered for = 72 hours. - History of immunodeficiency. Participants with HIV are eligible if they have a CD4+ count = 300/µL, undetectable viral load, and maintained on antiretroviral therapy for a minimum of 4 weeks. - Prior autologous/allogeneic stem cell or tissue/solid organ transplant - Prior treatment with MGD009, enoblituzumab, or other B7-H3 targeted agents for cancer. - Clinically significant cardiovascular disease, lung compromise, venous insufficiency, or gastrointestinal disorders. - Participants with greater than Grade 1 peripheral neuropathy. - Participants who have a history of severe adverse events (AEs) from immune checkpoint inhibitors (anti-PD-1, anti-PD-L1, or CTLA-4 inhibitors). All other AEs from prior immune checkpoint inhibitors must be resolved to Grade 1 or less. Participants with any grade neurologic toxicity from prior immune checkpoint inhibitors are excluded. - Pleural effusion or ascites. Trace pleural or peritoneal fluid is not exclusionary. - History of Guillain-Barre syndrome, myasthenia gravis, or other autoimmune sensory or motor neuropathies.

Study Design


Intervention

Biological:
vobramitamab duocarmazine
Vobramitamab duocarmazine is an antibody drug conjugate (ADC) targeted against B7-H3.
lorigerlimab
Lorigerlimab is a bispecific DART® molecule that binds PD-1 and CTLA-4.

Locations

Country Name City State
United States Winship Cancer Institute of Emory University Atlanta Georgia
United States Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Baltimore Maryland
United States University of Virginia Comprehensive Cancer Center Charlottesville Virginia
United States Carolina BioOncology Huntersville North Carolina
United States University of California, Los Angeles Los Angeles California
United States Weill Cornell Medicine New York New York
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 California, San Francisco San Francisco California
United States Florida Cancer Specialists and Research Institute Sarasota Florida

Sponsors (1)

Lead Sponsor Collaborator
MacroGenics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with adverse events (AEs) Up to 2 years
Primary Number of participants with serious adverse events (SAEs) Up to 2 years
Primary Number of participants with AEs leading to study treatment discontinuation Up to 2 years
Secondary Maximum observed concentration (Cmax) of vobramitamab duocarmazine Peak concentration of vobramitamab duocarmazine Cycle 1 Day 1 Preinfusion, end of infusion (EOI [1-hour]), 2 hours and 5 hours after EOI, Day 8; Day 15; Cycle 2 Day 1 Preinfusion, EOI, 1 hour after EOI; Day 8; Day 15; Day 1 of subsequent cycles pre-infusion and EOI (every 4 weeks) up to 2 years
Secondary Maximum observed concentration (Cmax) of lorigerlimab Peak concentration of lorigerlimab Cycle 1 Day 1 Preinfusion, end of infusion (EOI [1-hour]), 1 hour and 4 hours after EOI, Day 8, Day 15; Cycle 2 Day 1 Preinfusion, EOI, 1 hour after EOI; Day 8, Day 15; Day 1 of subsequent cycles pre-infusion and EOI (every 4 weeks) up to 2 years
Secondary Time to maximum concentration (Tmax) of vobramitamab duocarmazine Time at which peak concentration of vobramitamab duocarmazine is observed Cycle 1 Day 1 Preinfusion, end of infusion (EOI [1-hour]), 2 hours and 5 hours after EOI, Day 8; Day 15; Cycle 2 Day 1 Preinfusion, EOI, 1 hour after EOI; Day 8, Day 15; Day 1 of subsequent cycles pre-infusion and EOI (every 4 weeks) up to 2 years.
Secondary Time to maximum concentration (Tmax) of lorigerlimab Time at which peak concentration of lorigerlimab is observed Cycle 1 Day 1 Preinfusion, end of infusion (EOI [1-hour]), 1 hour and 4 hours after EOI, Day 8; Day 15; Cycle 2 Day 1 Preinfusion, EOI, 1 hour after EOI; Day 8, Day 15; Day 1 of subsequent cycles pre-infusion and EOI (every 4 weeks) up to 2 years.
Secondary 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 Cycle 1 Day 1 Preinfusion, end of infusion (EOI [1-hour)], 2 hours and 5 hours after EOI, Day 8; Day 15; Cycle 2 Day 1 Preinfusion, EOI, 1 hour after EOI; Day 8, Day 15; Day 1 of subsequent cycles pre-infusion and EOI (every 4 weeks) up to 2 years.
Secondary 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 Cycle 1 Day 1 Preinfusion, end of infusion (EOI [1-hour]), 1 hours and 4 hours after EOI, Day 8; Day 15; Cycle 2 Day 1 Preinfusion, EOI, Day 8, Day 15; Day 1 of subsequent cycles pre-infusion and EOI (every 4 weeks) up to 2 years.
Secondary Trough concentration of vobramitamab duocarmazine Concentration of vobramitamab duocarmazine at the end of a dosing interval Day 1 of each cycle (every 4 weeks) up to 2 years.
Secondary Trough concentration of lorigerlimab Concentration of lorigerlimab at the end of a dosing interval Day 1 of each cycle (every 4 weeks) up to 2 years.
Secondary Number of participants who develop anti-drug antibodies (ADA) to vobramitamab duocarmazine Assessed every 4 weeks up to 2 years
Secondary Number of participants who develop ADA to lorigerlimab Assessed every 4 weeks up to 2 years
Secondary Objective response rate (ORR) Assessed every 8 weeks for the first 6 months, then every 12 weeks for up to 2 years.
Secondary 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. 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.
Secondary 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. Assessed every 8 weeks for the first 6 months, then every 12 weeks for up to 2 years.
Secondary Overall survival (OS) OS is defined as the time from the first dose date to the date of death from any cause. 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
Secondary 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 Assessed every 8 weeks for the first 6 months, then every 12 weeks for up to 2 years.
Secondary 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. 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.
Secondary Best PSA percent change for mCRPC 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.
Secondary 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. 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.
Secondary 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. 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.
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