NCT06723236 A Study of MGC028 in Participants With Advanced Solid Tumors
| NCT ID | NCT06723236 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | MacroGenics |
| Condition | Advanced Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 124 participants |
| Start Date | 2025-02-13 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 124 participants in total. It began in 2025-02-13 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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). 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.
Eligibility Criteria
Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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.
Contact & Investigator
Pepi Pencheva, M.D.
STUDY DIRECTOR
MacroGenics
Frequently Asked Questions
Who can join the NCT06723236 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06723236 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06723236 currently recruiting?
Yes, NCT06723236 is actively recruiting participants. Contact the research team at info@macrogenics.com for enrollment information.
Where is the NCT06723236 trial being conducted?
This trial is being conducted at San Francisco, United States, Boston, United States, Boston, United States, Grand Rapids, United States and 3 additional locations.
Who is sponsoring the NCT06723236 clinical trial?
NCT06723236 is sponsored by MacroGenics. The principal investigator is Pepi Pencheva, M.D. at MacroGenics. The trial plans to enroll 124 participants.