A Study of MGC026 in Participants With Advanced Solid Tumors
- Conditions
- Advanced CancerBladder CancerCastration Resistant Prostatic CancerCervical CancerMetastatic CancerEndometrial CancerMelanomaGastro-esophageal CancerClear Cell Renal Cell CarcinomaHepatocellular Carcinoma
- Interventions
- Biological: MGC026 Dose EscalationBiological: MGC026 Dose for Expansion
- Registration Number
- NCT06242470
- Lead Sponsor
- MacroGenics
- Brief Summary
The study is designed to understand the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of MGC026 in participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors The study has a dose escalation portion and a cohort expansion portion of the study.
Participants will receive MGC026 by intravenous (IV) infusion. The dose of MGC026 will be assigned at the time of enrollment. Participants may receive up to 35 treatments if there are no severe side effects and as long as the cancer does not get worse. Participants will be monitored for side effects, and progression of cancer, have blood samples collected for routing laboratory work, and blood samples collected for research purposes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 230
- Adults ≥ 18 years old, able to provide informed consent
- Adequate performance and laboratory parameters
- Unresectable, locally advanced or metastatic solid tumors including: squamous cell cancer (SCC) of the head and neck, esophageal SCC, squamous and non-squamous non-small cell lung cancer, small cell lung cancer, bladder cancer, sarcoma, endometrial cancer, melanoma, castration resistant prostate cancer, breast cancer, ovarian cancer, cervical cancer, colorectal cancer gastric or gastroesophageal cancer, pancreatic carcinoma, clear cell renal cell cancer or hepatocellular cancer.
- Measurable disease per RECIST v1.1. Participants with metastatic CRPC without measurable disease are eligible.
- Must be willing to use highly effective methods of birth control from the time of consent through 7 months after discontinuation of MGC026.
- Not pregnant or breastfeeding.
- Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.
- Another cancer that required treatment within the past 2 years, with the exception of those with low risk of cancer spreading or death such as adequately treated non melanomatous skin cancer, localized prostate cancer (Gleason Score < 6), or carcinoma in situ.
- Patients with history of prior central nervous system (CNS) metastasis must have been treated, be asymptomatic, and not have concurrent treatment for CNS disease, progression of CNS metastases on magnetic resonance imaging, computed tomography or positron emission tomography, or history of leptomeningeal disease or cord compression at the time of enrollment.
- Treatment with surgery, systemic cancer therapy, immunotherapy, chimeric antigen receptor-T therapy, or anti-hormonal within protocol specified intervals.
- Prior autologous or allogeneic stem cell or solid organ transplant.
- Clinically significant cardiovascular, pulmonary, or gastrointestinal disorders.
- Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 1 week of first study drug administration.
- Known history of hepatitis B or C infection or known positive test for hepatitis B surface antigen or core antigen, or hepatitis C polymerase chain reaction.
- Known positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome.
- History of primary immunodeficiency.
- Major trauma or major surgery within 4 weeks of first study drug administration.
- Known hypersensitivity to recombinant proteins.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort 2 MGC026 Dose Escalation - Cohort 5 MGC026 Dose Escalation - Cohort 6 MGC026 Dose Escalation - Expansion cohort 4 MGC026 Dose for Expansion - Cohort 4 MGC026 Dose Escalation - Expansion cohort 1 MGC026 Dose for Expansion - Cohort 3 MGC026 Dose Escalation - Expansion cohort 2 MGC026 Dose for Expansion - Cohort 1 MGC026 Dose Escalation - Expansion cohort 3 MGC026 Dose for Expansion -
- Primary Outcome Measures
Name Time Method Number of participants with adverse events (AEs) and serious AEs (SAEs) Throughout the study, up to 135 weeks
- Secondary Outcome Measures
Name Time Method Duration of response (DoR) in advanced solid tumors Throughout the study, up to 135 weeks DoR is defined as the time from the date of initial response (CR or PR) to the date of first documented progression or death from any cause, whichever occurs first. (RECIST 1.1) is used to classify responses.
ORR rate in metastatic castration resistant prostate cancer (mCRPC) Throughout the study, up to 135 weeks The ORR per Prostate Cancer Working Group 3 (PCWG3) criteria is estimated as the proportion of participants in the Response Evaluable population who achieve best overall response of CR or PR (called responders).
Mean (SD) of MGC026 area under the time concentration curve (AUC) Day 1 of every 21-day cycle, throughout the study, average of 1 year. Calculated exposure to MGC026
Number of participants who develop anti-MGC026 antibodies (immunogenicity) Day 1 of every 21-day cycle, throughout the study, average of 1 year. Development of anti-MGC026 antibodies in the bloodstream
Overall response rate in advanced solid tumors Throughout the study, up to 135 weeks The objective response rate (ORR) per RECIST v1.1 is estimated as the proportion of participants in the Response Evaluable population who achieve best overall response of complete response (CR) or partial response (PR) (called responders). Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) is used to classify responses.
DoR in mCRPC Throughout the study, up to 135 weeks DoR is defined as the time from the date of initial response (CR or PR) to the date of first documented progression, per PCWG3 criteria or death from any cause, whichever occurs first.
Mean (standard deviation [SD]) of MGC026 maximum serum concentration (Cmax) Day 1 of every 21-day cycle, throughout the study, average of 1 year. The maximum concentration in the bloodstream at the end of the infusion.
Trial Locations
- Locations (11)
The Royal Marsden NHS Foundation Trust
🇬🇧Sutton, United Kingdom
Oxford University Hospitals NHS Foundation Trust
🇬🇧Oxford, United Kingdom
The Angeles Clinic and Research Institute
🇺🇸Los Angeles, California, United States
START Midwest
🇺🇸Grand Rapids, Michigan, United States
Providence Cancer Institute
🇺🇸Portland, Oregon, United States
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
START Mountain Region
🇺🇸West Valley City, Utah, United States
ICON Cancer Centre Wesley
🇦🇺Auchenflower, Queensland, Australia
ICON Cancer Centre Kurralta Park
🇦🇺Kurralta Park, South Australia, Australia
Austin Health- Olivia Newton John Cancer Center
🇦🇺Heidelberg, Victoria, Australia