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Looking for participantsPhase1

A Study of MGC026 in Participants With Advanced Solid Tumors

Sponsor: MacroGenics

NCT ID: NCT06242470

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
MGC026 Dose Escalation (biological), MGC026 Dose for Expansion (biological)
How long the study runs
Study runs about 55 months (dates as stated)
About the drug or intervention
MGC026 Dose Escalation — biological: Escalating doses of MGC026 · MGC026 Dose for Expansion — biological: MGC026 recommended dose for expansion
Patient visit burden
Not specified by the sponsor

In plain English

This study is testing a new medicine called MGC026 in adults with advanced or spread (metastatic) solid cancers, including many types such as lung, breast, bowel, prostate, ovarian and skin cancer. The study is run by a company called MacroGenics.

Who can take part

  • Adults aged 18 or over who can give informed consent
  • Have an advanced or spread solid tumour that cannot be removed by surgery, from a list of cancer types such as head and neck, lung, bladder, breast, ovarian, bowel, pancreatic, liver, skin (melanoma), prostate and others
  • In generally good enough health, based on how well you feel day to day and blood tests
  • Have cancer that can be measured on scans, though people with prostate cancer that has spread without measurable disease can still join
  • A sample of your tumour is needed (an old stored sample, or a new biopsy if that is safe and possible)
  • Willing to use highly effective birth control from consent until 7 months after stopping MGC026
  • Not pregnant or breastfeeding

Who may not be able to

  • Another medical or mental health condition that would make it hard to receive or cope with the treatment or study visits
  • Another cancer treated in the past 2 years, except low-risk ones like treated non-melanoma skin cancer, low-grade localised prostate cancer, or carcinoma in situ
  • Untreated or worsening cancer spread to the brain or spinal cord, or a history of certain nervous system problems
  • Recent surgery, chemotherapy, immunotherapy, cell therapy (CAR-T) or hormone therapy within set time periods
  • Previous treatment with any medicine targeting B7-H3, or any antibody-drug conjugate (a medicine joined to a chemotherapy-type payload) carrying a topoisomerase payload
  • Previous stem cell transplant or solid organ transplant
  • Significant heart, lung or gut problems
  • An active infection needing treatment into a vein within 1 week of the first dose
  • Hepatitis B or C infection, HIV or AIDS, or a history of immune system problems from birth
  • Major injury or major surgery within 4 weeks of the first dose
  • Known serious allergy to recombinant proteins (proteins made in a lab)

What taking part involves

  • • Receiving the study medicine MGC026
  • • Providing a tumour sample, either an old stored sample or a new biopsy if needed
  • • Scans and tests to check your cancer and health during the study — details not stated, ask the trial team

Time commitment: Number of visits and how long the study lasts: Not stated — ask the trial team.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
250
Started
2024-03-06
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for advanced solid tumor
  • • Phase1 - 250 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with advanced solid tumor

Where?

  • • Oxford - Oxford University Hospitals NHS Foundation Trust
  • • Sutton - The Royal Marsden NHS Foundation Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Advanced Solid TumorAdvanced CancerMetastatic CancerSquamous Cell Carcinoma of Head and NeckNon Small Cell Lung CancerSmall-cell Lung CancerBladder CancerSarcomaEndometrial CancerMelanomaCastration Resistant Prostatic CancerCervical CancerColorectal CancerGastric CancerGastro-esophageal CancerPancreas CancerClear Cell Renal Cell CarcinomaHepatocellular CarcinomaPlatinum-resistant Ovarian CancerBreast CancerOvarian CancerEsophageal Squamous Cell Cancer (SCC)

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

known positive

What the study is looking for

  • ✓Adults ≥ 18 years old, able to provide agreement to take part
  • ✓Adequate performance and laboratory parameters
  • ✓cancer that can be measured on scans v1.1. Participants with that has spread CRPC without cancer that can be measured on scans are eligible.
  • ✓Must be willing to use highly effective methods of birth control from the time of consent through 7 months after...
  • ✓Not pregnant or breastfeeding.

Who cannot take part

  • ✗Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with...
  • ✗Treatment with surgery, systemic cancer therapy, treatment that helps your immune system fight cancer, chimeric antigen receptor-T therapy, or...
  • ✗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, lung, or gastrointestinal disorders.
See the full criteria
Inclusion Criteria: * 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. 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 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.

Where Is This Study? (2 UK sites)

Oxford University Hospitals NHS Foundation Trust

Oxford OX3 9DU, United Kingdom

Recruiting
Hospital R&D contact (matched)

Shahista Hussain

ouhtma@ouh.nhs.uk---

The Royal Marsden NHS Foundation Trust

Sutton SM2 5PT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

How to Get in Touch

Global Trial Manager

Sponsor contact

CONTACT

301-251-5172 info@macrogenics.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-08