A Study of MGC026 in Participants With Advanced Solid Tumors

March 13, 2024 updated by: MacroGenics

A Phase 1/1b First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC026 in Participants With Advanced Solid Tumors

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

230

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Recruiting
        • START Midwest
    • Utah
      • West Valley City, Utah, United States, 84119
        • Recruiting
        • START Mountain Region

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

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 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
Biological: MGC026 Dose Escalation
Escalating doses of MGC026
Experimental: Cohort 2
Biological: MGC026 Dose Escalation
Escalating doses of MGC026
Experimental: Cohort 3
Biological: MGC026 Dose Escalation
Escalating doses of MGC026
Experimental: Cohort 4
Biological: MGC026 Dose Escalation
Escalating doses of MGC026
Experimental: Cohort 5
Biological: MGC026 Dose Escalation
Escalating doses of MGC026
Experimental: Cohort 6
Biological: MGC026 Dose Escalation
Escalating doses of MGC026
Experimental: Expansion cohort 1
Biological: MGC026 Dose for Expansion
MGC026 recommended dose for expansion
Experimental: Expansion cohort 2
Biological: MGC026 Dose for Expansion
MGC026 recommended dose for expansion
Experimental: Expansion cohort 3
Biological: MGC026 Dose for Expansion
MGC026 recommended dose for expansion
Experimental: Expansion cohort 4
Biological: MGC026 Dose for Expansion
MGC026 recommended dose for expansion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events (AEs) and serious AEs (SAEs)
Time Frame: Throughout the study, up to 135 weeks
Throughout the study, up to 135 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate in advanced solid tumors
Time Frame: 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.
Throughout the study, up to 135 weeks
Duration of response (DoR) in advanced solid tumors
Time Frame: 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.
Throughout the study, up to 135 weeks
ORR rate in metastatic castration resistant prostate cancer (mCRPC)
Time Frame: 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).
Throughout the study, up to 135 weeks
DoR in mCRPC
Time Frame: 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.
Throughout the study, up to 135 weeks
Mean (standard deviation [SD]) of MGC026 maximum serum concentration (Cmax)
Time Frame: 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.
Day 1 of every 21-day cycle, throughout the study, average of 1 year.
Mean (SD) of MGC026 area under the time concentration curve (AUC)
Time Frame: Day 1 of every 21-day cycle, throughout the study, average of 1 year.
Calculated exposure to MGC026
Day 1 of every 21-day cycle, throughout the study, average of 1 year.
Number of participants who develop anti-MGC026 antibodies (immunogenicity)
Time Frame: Day 1 of every 21-day cycle, throughout the study, average of 1 year.
Development of anti-MGC026 antibodies in the bloodstream
Day 1 of every 21-day cycle, throughout the study, average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MacroGenics

Investigators

  • Study Director: Denise Casey, MD, MacroGenics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2024

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

January 12, 2024

First Submitted That Met QC Criteria

February 1, 2024

First Posted (Actual)

February 5, 2024

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-MGC026-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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