Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

Summary

Study CP-MGC018-02 is a study of vobramitamab duocarmazine (MGC018) in combination with lorigerlimab. 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, 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 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. .

Official Title

A Phase 1/1b Dose Escalation and Cohort Expansion Study of MGC018 in Combination With Checkpoint Inhibitor in Participants With Advanced Solid Tumors

Keywords

Advanced Solid Tumor, Castration-Resistant Prostatic Cancer, Malignant Melanoma, Pancreatic Ductal Carcinoma, Hepatocellular Cancer, Epithelial Ovarian Cancer, Renal Cell Carcinoma, Carcinoma, Melanoma, Ovarian Epithelial Carcinoma, Ductal Carcinoma, Liver Neoplasms, Hepatocellular Carcinoma, Prostatic Neoplasms, Castration-Resistant Prostatic Neoplasms, vobramitamab duocarmazine, lorigerlimab

Eligibility

You can join if…

Open to people ages 18 years and up

    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.

You CAN'T join if...

  • 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.

Locations

  • UCSF not yet accepting patients
    San Francisco California 94158 United States
  • University of California, Los Angeles accepting new patients
    Los Angeles California 90095 United States
  • Stephenson Cancer Center, The University of Oklahoma accepting new patients
    Oklahoma City Oklahoma 73104 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
MacroGenics
ID
NCT05293496
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 278 study participants
Last Updated