A Study of MGC026 in Participants With Advanced Solid Tumors

NCT06242470
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
250
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Lead sponsor
MacroGenics
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Start date
2024-03-06
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Number of sites
12
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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.
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Short title
A Study of MGC026 in Participants With Advanced Solid Tumors
clinicaltrials.gov
Official title
A Phase 1/1b First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC026 in Participants With Advanced Solid Tumors
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2028-10-01
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First posted
2024-02-05
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Registry last updated
2026-08-11
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Primary completion date
2028-05-01
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Start date
2024-03-06
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Participants
250
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Participant count basis
Estimated
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Planned participants
250
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Protocol amendments
3
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Number of sites
12
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
MacroGenics
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06242470
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ClinicalTrials.gov ID
NCT06242470
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Number of participants with adverse events (AEs) and serious AEs (SAEs), AEs leading to dose delay, AEs leading to dose reduction, AEs leading to treatment discontinuations, AEs meeting criteria for dose limiting toxicity, and AEs of special interest.

    Timeframe: Throughout the study, up to 135 weeks

  1. Overall response rate in advanced solid tumors

    Timeframe: Throughout the study, up to 135 weeks

    The objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) is used to estimate the proportion of participants in the Response Evaluable population who achieve best overall response of complete response (CR) or partial response (PR) (called responders). Complete response (CR) is defined as disappearance of all target and non-target lesions. Partial response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, no progression of non-target lesions, and no new lesions

  2. Duration of response (DoR) in advanced solid tumors

    Timeframe: 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.

  3. ORR rate in metastatic castration resistant prostate cancer (mCRPC)

    Timeframe: 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).

  4. DoR in mCRPC

    Timeframe: 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.

  5. Mean (standard deviation [SD]) of MGC026 total and conjugated antibody maximum serum concentration (Cmax)

    Timeframe: Cycle 1 Day 1: at baseline, end of infusion (EOI) approximately 1 hr, 4hrs after EOI, Day 2 and Day 4.

    The maximum concentration in the bloodstream at the end of the infusion.

  6. Mean (standard deviation [SD]) of MGC026 unconjugated payload Cmax

    Timeframe: Cycle 1 Day 1: at baseline, end of infusion (EOI) approximately 1 hr, 4hrs after EOI, Day 2 and Day 4.

    The maximum concentration in the bloodstream at the end of the infusion.

  7. Mean (SD) of MGC026 total and conjugated antibody area under the time concentration curve (AUC)

    Timeframe: Cycle 1 Day 1: at baseline, EOI approximately 1 hr, 4hrs after EOI, Day 2, Day 4, Day 8, Day 15, and predose Cycle 2 Day 1

    Calculated exposure to MGC026

  8. Mean (SD) of MGC026 unconjugated payload AUC

    Timeframe: Cycle 1 Day 1: at baseline, EOI approximately 1 hr, 4hrs after EOI, Day 2, Day 4, Day 8, Day 15, and predose Cycle 2 Day 1

    Calculated exposure to MGC026

  9. Number of participants who develop anti-MGC026 antibodies (immunogenicity)

    Timeframe: Day 1, Day 15, and Day 1 of every 21-day cycle, throughout the study, average of 1 year.

    Development of anti-MGC026 antibodies in the bloodstream

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • Adults ≥ 18 years old, able to provide informed consent
  • Adequate performance and laboratory parameters
  • Availability of archival or formalin-fixed paraffin-embedded tumor tissue sample. Participants may undergo a fresh tumor biopsy to obtain a specimen for testing if an archival tumor sample is not available. Participants with no available archival tissue sample who cannot safely undergo a fresh biopsy as determined by consultation between the sponsor and investigator are eligible
  • 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 treatment with any B7-H3 targeted agent for cancer or any ADC with a topoisomerase payload.
  • 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.
Sources for eligibility
clinicaltrials.gov

  • The Angeles Clinic and Research InstituteLos Angeles, United StatesRecruiting
  • START MidwestGrand Rapids, United StatesRecruiting
  • START-New York Long IslandLake Success, United StatesRecruiting
  • Providence Cancer InstitutePortland, United StatesRecruiting
  • The University of Texas MD Anderson Cancer CenterHouston, United StatesRecruiting
  • University of Texas Health Science Center at HoustonHouston, United StatesRecruiting
  • START Mountain RegionWest Valley City, United StatesRecruiting
  • ICON Cancer Centre WesleyAuchenflower, AustraliaRecruiting
  • ICON Cancer Centre Kurralta ParkKurralta Park, AustraliaRecruiting
  • Austin Health- Olivia Newton John Cancer CenterHeidelberg, AustraliaRecruiting
  • Oxford University Hospitals NHS Foundation TrustOxford, United KingdomRecruiting
  • The Royal Marsden NHS Foundation TrustSutton, United KingdomRecruiting
Sources for sites
clinicaltrials.gov

Related records

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