Urothelial CancerPhase 1NCT07822399
A Study of MGC030 in Participants With Advanced Solid Tumors
A Phase 1 study testing MGC030 in people with Urothelial Cancer and GastroEsophageal Cancer, run by MacroGenics.
Trial summary
The study is designed to characterize safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary anti-tumor activity of MGC030. Participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors of select types. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Cancer, GastroEsophageal Cancer, Colorectal Cancer
- What is being tested?
- MGC030
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Mar 2029
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants in dose escalation cohorts must have histologically proven unresectable, locally advanced or metastatic solid tumor limited to one of the following types: urothelial cancer, colorectal cancer (CRC), gastric or gastroesophageal junction (GEJ) cancer, esophageal cancer, or pancreatic carcinoma that is refractory to standard therapy, or for which standard therapy does not exist, has proven to be intolerable, or has been refused by the participant.
- Participants in expansion cohorts must have histologically proven, unresectable, locally advanced or metastatic solid tumors
- Urothelial cancer with progression following platinum-containing chemotherapy for metastatic or locally advanced/unresectable cancer, or within 12 months from completion of neo-adjuvant or adjuvant platinum-containing chemotherapy for localized muscle-invasive cancer.
- Gastric/GEJ carcinoma with progression during or following at least 1 systemic therapy.
- Esophageal cancer with progression during or following at least 1 systemic therapy.
- CRC with progression during or following treatment with at least 2 prior lines of systemic therapy (containing a fluoropyrimidine plus a platinum analogue and/or irinotecan) for metastatic disease.
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- CRC harboring an activating EGFR mutation must have progressed during or following at least one EGFR targeted therapy, if available.
- Participants should have received no more than 4 prior lines of systemic therapy for advanced or metastatic disease.
- Pancreatic cancer with progression during or following at least 1 systemic therapy. Participants should have received no more than 2 prior lines of cytotoxic chemotherapy for advanced or metastatic disease.
- Participants must have at least one lesion that meets the definition of measurable disease by RECIST v1.1.
- Participants must have an available archival or formalin-fixed paraffin-embedded tumor tissue or be willing to undergo a biopsy procedure to obtain a fresh tumor sample.
- Participants have acceptable physical condition and laboratory values.
- Participants of childbearing potential must agree to use highly effective methods of birth control.
- Participants must not be pregnant, planning to be pregnant, or breastfeeding.
Who cannot join
- Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.
- Active brain metastases or leptomeningeal metastases.
- Prior stem cell, tissue, or solid organ transplant.
- Another malignancy that required treatment within the past 2 years, with the exception of those with a negligible risk of metastasis or death such as adequately treated non-melanomatous skin cancer, localized prostate cancer (Gleason Score < 6), or carcinoma in situ.
- History of primary immunodeficiency.
- Active viral, bacterial, or fungal infection
- Prior treatment with Topoisomerase 1-based ADCs for cancer.
- Prior treatment with major surgery, mediastinal or lung radiation, vaccination with live virus vaccines, systemic cancer treatment, chimeric antigen receptor (CAR)-T cell therapy, or experimental treatment within 4 weeks of the start of study treatment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1, First-in-Human, Open Label, Dose Escalation, Dose Optimization, and Cohort Expansion Study of MGC030 in Participants With Advanced Solid Tumors
The study is designed to characterize safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary anti-tumor activity of MGC030. Participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors of select types.
The main question the study aims to answer is:
- What types of side effects will participants experience when receiving MGC030?
- Can MGC030 cause cancer to shrink, remain stable, or able to control disease progression of participants with advanced solid tumors? Participants will
- Undergo screening procedures to determine eligibility
- Receive study treatments initially every 3 weeks.
- Have blood samples taken for routine and research tests
- Have other examinations to check heart and lung function, and general health status
- Be asked about any side effects that may be happening or other medications you are taking. The study doctor will provide treatment for side effects, if necessary.
- Have the study doctor assess your tumor status at regular intervals to determine how you are responding to treatment.
- Conditions
- Urothelial Cancer, GastroEsophageal Cancer, Colorectal Cancer, Esophageal Cancer, Gastric Cancer (GC), Pancreatic Cancer
- Being tested
- MGC030
- Medical subject headings
- Colorectal Neoplasms, Esophageal Neoplasms, Stomach Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MGC030Biological
Antibody-drug conjugate
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation Cohort 1 | Experimental | MGC030 Dose Level 1 Receives: Biological: MGC030 |
| Dose escalation Cohort 2 | Experimental | MGC030 Dose Level 2 Receives: Biological: MGC030 |
| Dose escalation Cohort 3 | Experimental | MGC030 Dose Level 3 Receives: Biological: MGC030 |
| Dose escalation Cohort 4 | Experimental | MGC030 Dose Level 4 Receives: Biological: MGC030 |
| Dose escalation Cohort 5 | Experimental | MGC030 Dose Level 5 Receives: Biological: MGC030 |
| Dose escalation Cohort 6 | Experimental | MGC030 Dose Level 6 Receives: Biological: MGC030 |
| Dose Optimization Cohort 1 | Experimental | Dose Optimization Dose Level 1 Receives: Biological: MGC030 |
| Dose Optimization Cohort 2 | Experimental | Dose Optimization Dose Level 2 Receives: Biological: MGC030 |
| Expansion Cohort 1 | Experimental | Recommended dose for expansion Receives: Biological: MGC030 |
| Expansion Cohort 2 | Experimental | Recommended dose for expansion Receives: Biological: MGC030 |
| Expansion Cohort 3 | Experimental | Recommended dose for expansion Receives: Biological: MGC030 |
| Expansion Cohort 4 | Experimental | Recommended dose for expansion Receives: Biological: MGC030 |
| Expansion Cohort 5 | Experimental | Recommended dose for expansion Receives: Biological: MGC030 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs), serious AEs (SAEs), AEs leading to dose interruption, AEs leading to dose reduction or treatment discontinuation, does limiting toxicities and AEs of special interest.
Measured: Throughout the study, estimated duration 2 years.
Secondary outcomes (4)
Mean concentrations MGC030 antibody-drug conjugate, total antibody and unconjugated payload.
Measured: Throughout the study treatment period, up to 2 years
Number of Participants Who Develop Anti-Drug Antibodies to MGC030
Measured: Throughout the study treatment period, up to 2 years
Objective response rate
The ORR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 is estimated as the proportion of participants in the Response Evaluable Population who achieve Best Overall Response of Complete Response or Partial Response.
Measured: Throughout the study treatment period, up to 2 years
Duration of Response
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.
Measured: Throughout the study treatment period, up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 314 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MacroGenics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank Perabo, MD, PhD, Study director, MacroGenics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07822399
- Sponsor's protocol ID
- CP-MGC030-01
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No