Advanced Solid TumorsPhase 1NCT06723236
A Study of MGC028 in Participants With Advanced Solid Tumors
A Phase 1 study testing MGC028 in people with Advanced Solid Tumors and NSCLC Adenocarcinoma, run by MacroGenics at 7 sites in United States.
Trial summary
The goal of this clinical trial is to characterize the safety, tolerability, dose-limiting toxicities (DLT), and maximum tolerated dose (MTD) or maximum administered dose of MGC028 (if no MTD is defined). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors, NSCLC Adenocarcinoma, Cholangiocarcinoma
- What is being tested?
- MGC028
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 7 sitesUnited States
- Study dates
- 13 Feb 2025to Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 or supplemental cohorts must have histologically proven unresectable, locally advanced or metastatic solid tumor limited to one of the following types: NSCLC adenocarcinoma, cholangiocarcinoma, colorectal carcinoma (CRC), 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 either
- NSCLC adenocarcinoma with
- progression on or following anti-PD-1/PD-L1 inhibitor, unless contraindicated
- progression on or following therapy for actionable mutations (e.g. EGFR or ALK mutations), if present
- no more than 2 prior lines of cytotoxic chemotherapy for advanced or metastatic disease.
Show all 19Show fewer
- Pancreatic cancer
- following at least 1 systemic therapy
- no more than 2 prior lines of cytotoxic therapy for advanced or metastatic disease.
- Colorectal adenocarcinoma with
- Progression during or following standard therapy with a fluoropyrimidine-based chemotherapy, oxaliplatin and irinotecan unless contraindicated, refused or unavailable
- Progression after prior targeted treatment for CRC with actionable mutations such as EGFR, KRAS, BRAF and MSI- H/dMMR, if present.
- No more that 2 lines of cytotoxic chemotherapy for advanced or metastatic disease
- No more than 4 lines of systemic regimens 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.
- Active viral, bacterial, or fungal infection
- Prior treatment with ADAM9 targeted agent 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
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Mass General Brigham
Boston, Massachusetts, 02114
Harshaband Singh
- Recruiting
Dana Farber/Harvard Cancer Center
Boston, Massachusetts, 02115
Kimberly Perez
- Recruiting
South Texas Accelerated Research Therapeutics (START) Midwest
Grand Rapids, Michigan, 49546
Manish Sharma
- Recruiting
Icahn School of Medicine at Mt. Sinai
New York, New York, 10029
Deborah Doroshow
- Recruiting
South Texas Accelerated Research Therapeutics (START) San Antonio
San Antonio, Texas, 78229
Drew Rasco
- Recruiting
UCSF - Helen Diller Family Cancer Center
San Francisco, California, 94115
Pamela Munster
- Recruiting
South Texas Accelerated Research Therapeutics (START) Mountain Region
West Valley City, Utah, 84119
Justin Call
About this study
Official title: A Phase 1, First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC028 in Participants With Advanced Solid Tumors
The goal of this clinical trial is to characterize the safety, tolerability, dose-limiting toxicities (DLT), and maximum tolerated dose (MTD) or maximum administered dose of MGC028 (if no MTD is defined). The study will enroll adult participants with relapsed or refractory, unresectable, locally advanced of metastatic solid tumors known to express ADAM9.
The main question the study aims to answer is:
Read more
- What types of side effects will participants experience when receiving MGC028?
- Can MGC028 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
- Advanced Solid Tumors, NSCLC Adenocarcinoma, Cholangiocarcinoma, Pancreatic Carcinoma, Colorectal Carcinoma
- Being tested
- MGC028
- Medical subject headings
- Cholangiocarcinoma, Pancreatic Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MGC028Biological
MGC028 is an antibody-drug conjugate targeted against ADAM9.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Dose level 1 of MGC028, IV Receives: Biological: MGC028 |
| Cohort 2 | Experimental | Dose level 2 of MGC028, IV Receives: Biological: MGC028 |
| Cohort 3 | Experimental | Dose level 3 of MGC028, IV Receives: Biological: MGC028 |
| Cohort 4 | Experimental | Dose level 4 of MGC028, IV Receives: Biological: MGC028 |
| Cohort 5 | Experimental | Dose level 5 of MGC028, IV Receives: Biological: MGC028 |
| Cohort 6 | Experimental | Dose level 6 of MGC028, IV Receives: Biological: MGC028 |
| Expansion Cohort 1 | Experimental | MTD or MAD of MGC028, IV Receives: Biological: MGC028 |
| Expansion Cohort 2 | Experimental | MTD or MAD of MGC028, IV Receives: Biological: MGC028 |
| Expansion Cohort 3 | Experimental | MTD or MAD of MGC028, IV Receives: Biological: MGC028 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Types of Adverse Events (AEs) in Participants Receiving MGC028
Types of AEs include Serious Adverse Events (SAEs), and AEs Leading to Treatment Delay or Discontinuation or Dose Reduction, dose limiting toxicities, and AEs of Special Interest. Observation of side effects determines the highest safe dose for further study
Measured: Throughout the study treatment and safety follow up period, up to 25 months
Secondary outcomes (8)
Mean maximum concentration of MGC028 antibody
Measurement of the highest concentration of MGC028 conjugated and total antibody in the bloodstream.
Measured: Through Cycle 6 of the study, approximately 18 weeks
Mean Area Under the Concentration Time Curve of MGC028 antibody
Measurement of the total exposure of MGC028 conjugated and total antibody in the bloodstream.
Measured: Through Cycle 6 of the study, approximately 18 weeks
Number of Participants Who Develop Anti-Drug Antibodies to MGC028
Measured: Throughout the study treatment period, up to 2 years
Objective Response Rate (ORR)
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 and follow up period, up to 2.5 years.
Median 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 and follow up period, up to 2.5 years.
Mean maximum concentration of MGC028 free payload
Measurement of the highest concentration of MGC028 free payload in the bloodstream.
Measured: Through Cycle 6 of the study, approximately 18 weeks
Mean Area Under the Concentration Time Curve Total exposure of MGC028 payload
Measurement of the total exposure of MGC028 free payload in the bloodstream
Measured: Through Cycle 6 of the study, approximately 18 weeks
Change from baseline in the level of ADAM9 expression in tumor specimens, using immunohistochemistry
Measured: Baseline and approximately 28 days after the first dose of MGC028.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start13 Feb 2025
- Primary completionNov 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorsStudies 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
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MacroGenics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pepi Pencheva, M.D., Study director, MacroGenics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06723236
- Sponsor's protocol ID
- CP-MGC028-01
- Status last verified
- Apr 2026
- First submitted
- 4 Dec 2024
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Scribner JA, Brown JG, Son T, Jin L, McKenzie C, Nam V, Bush C, Quinonez D, Ford D, Tamura J, Gorlatov S, Summers A, Hav M, Li H, Sharma NK, Zhang X, Diedrich G, Butler S, Bonvini E, Loo D. Preclinical Development of MGC028, an ADAM9-Targeted, Glycan-Linked, Exatecan-Based Antibody-Drug Conjugate for the Treatment of Solid Cancers. Mol Cancer Ther. 2026 Apr 2;25(4):517-528. doi: 10.1158/1535-7163.MCT-25-0461.
PubMed 41166694
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC028 in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06723236
- Acronym / sponsor ID
- CP-MGC028-01
- Conditions
- Advanced Solid Tumors, NSCLC Adenocarcinoma, Cholangiocarcinoma, Pancreatic Carcinoma, Colorectal Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- MacroGenicsIndustry (pharma, biotech, devices)
- Study start
- 13 Feb 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to characterize the safety, tolerability, dose-limiting toxicities (DLT), and maximum tolerated dose (MTD) or maximum administered dose of MGC028 (if no MTD is defined). The study will enroll adult participants with relapsed or refractory, unresectable, locally advanced of metastatic solid tumors known to express ADAM9.
The main question the study aims to answer is:
- What types of side effects will participants experience when receiving MGC028?
- Can MGC028 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: MGC028Dose level 1 of MGC028, IV |
| Cohort 2 | Experimental | Biological: MGC028Dose level 2 of MGC028, IV |
| Cohort 3 | Experimental | Biological: MGC028Dose level 3 of MGC028, IV |
| Cohort 4 | Experimental | Biological: MGC028Dose level 4 of MGC028, IV |
| Cohort 5 | Experimental | Biological: MGC028Dose level 5 of MGC028, IV |
| Cohort 6 | Experimental | Biological: MGC028Dose level 6 of MGC028, IV |
| Expansion Cohort 1 | Experimental | Biological: MGC028MTD or MAD of MGC028, IV |
| Expansion Cohort 2 | Experimental | Biological: MGC028MTD or MAD of MGC028, IV |
| Expansion Cohort 3 | Experimental | Biological: MGC028MTD or MAD of MGC028, IV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Participants in dose escalation or supplemental cohorts must have histologically proven unresectable, locally advanced or metastatic solid tumor limited to one of the following types: NSCLC adenocarcinoma, cholangiocarcinoma, colorectal carcinoma (CRC), 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 either
- 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.
Key exclusion criteria (7 listed)
- 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.
- Active viral, bacterial, or fungal infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MGC028MGC028 is an antibody-drug conjugate targeted against ADAM9. | Biological | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Expansion Cohort 1, Expansion Cohort 2, Expansion Cohort 3 |
Primary outcome
Number and Types of Adverse Events (AEs) in Participants Receiving MGC028
Time frame: Throughout the study treatment and safety follow up period, up to 25 months
Types of AEs include Serious Adverse Events (SAEs), and AEs Leading to Treatment Delay or Discontinuation or Dose Reduction, dose limiting toxicities, and AEs of Special Interest. Observation of side effects determines the highest safe dose for further study
8 secondary outcomes
Mean maximum concentration of MGC028 antibody
Time frame: Through Cycle 6 of the study, approximately 18 weeks
Mean Area Under the Concentration Time Curve of MGC028 antibody
Time frame: Through Cycle 6 of the study, approximately 18 weeks
Number of Participants Who Develop Anti-Drug Antibodies to MGC028
Time frame: Throughout the study treatment period, up to 2 years
Objective Response Rate (ORR)
Time frame: Throughout the study and follow up period, up to 2.5 years.
Median Duration of Response
Time frame: Throughout the study and follow up period, up to 2.5 years.
Mean maximum concentration of MGC028 free payload
Time frame: Through Cycle 6 of the study, approximately 18 weeks
Mean Area Under the Concentration Time Curve Total exposure of MGC028 payload
Time frame: Through Cycle 6 of the study, approximately 18 weeks
Change from baseline in the level of ADAM9 expression in tumor specimens, using immunohistochemistry
Time frame: Baseline and approximately 28 days after the first dose of MGC028.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Derived from this study: PubMed 41166694Scribner JA, Brown JG, Son T, Jin L, McKenzie C, Nam V, Bush C, Quinonez D, Ford D, Tamura J, Gorlatov S, Summers A, Hav M, Li H, Sharma NK, Zhang X, Diedrich G, Butler S, Bonvini E, Loo D. Preclinical Development of MGC028, an ADAM9-Targeted, Glycan-Linked, Exatecan-Based Antibody-Drug Conjugate for the Treatment of Solid Cancers. Mol Cancer Ther. 2026 Apr 2;25(4):517-528. doi: 10.1158/1535-7163.MCT-25-0461.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pepi Pencheva, M.D. study director
MacroGenics
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MGC028 in people with Advanced Solid Tumors and NSCLC Adenocarcinoma, run by MacroGenics at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Global Trial Manager (301-251-5172, info@macrogenics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and Types of Adverse Events (AEs) in Participants Receiving MGC028 (time frame: Throughout the study treatment and safety follow up period, up to 25 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06723236, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.