Safety, PK, and Preliminary Efficacy of MBRC-101 in Advanced Refractory Solid Tumors
Public ClinicalTrials.gov record NCT06014658. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Open-label, Phase 1/1b / Phase 2 Dose Finding, Safety, and Pharmacokinetic Study of MBRC-101, an Anti-EphA5 Monomethyl Auristatin E (MMAE) Antibody Drug Conjugate, in Advanced Refractory Solid Tumors
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a first-in-human (FIH), open label Phase 1/1b / Phase 2 study in patients with advanced metastatic solid tumors refractory to standard treatment. Phase 1 will identify potential optimal biologically relevant doses (OBRD) and the maximum tolerated dose (MTD) of MBRC-101 at one 1 or more dosing regimens. Phase 1b will evaluate the safety and preliminary clinical activity of MBRC-101 at potential OBRDs. Phase 1 and Phase 1b will both characterize single and multiple-dose PK profiles and evaluate incidence and persistence of anti-MBRC-101 Ab. Phase 2 will evaluate the efficacy of MBRC-101 at the RP2D from Phase1b.
Study identification
- NCT ID
- NCT06014658
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 130 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 7, 2023 (Actual)
- Primary completion
- Jul 2026 (Estimated)
- Completion
- Nov 2026 (Estimated)
- Last update posted
- Mar 2, 2026
2023 – 2026
United States locations
- U.S. sites
- 17
- U.S. states
- 14
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94158 | Recruiting |
| University of Colorado, Anschutz Cancer Pavilion (ACP( | Aurora | Colorado | 80045 | Recruiting |
| Winship Cancer Institute, Emory University | Atlanta | Georgia | 30322 | Recruiting |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | Recruiting |
| Horizon Oncology Research | Lafayette | Indiana | 47905 | Completed |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | Recruiting |
| Comprehensive Cancer Center of Nevada | Las Vegas | Nevada | 89169 | Recruiting |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | Recruiting |
| Columbia University Irving Medical Center | New York | New York | 10032 | Recruiting |
| Carolina BioOncology Institute | Huntersville | North Carolina | 28078 | Active, not recruiting |
| University of Pennsylvania, Abramson Cancer Center | Philadelphia | Pennsylvania | 19014 | Recruiting |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | Recruiting |
| Medical University of South Carolina (MUSC) | Charleston | South Carolina | 29425 | Recruiting |
| PRISMA Health, Institute for Translational Oncology | Greenville | South Carolina | 29605 | Recruiting |
| NEXT Oncology | Austin | Texas | 78758 | Recruiting |
| NEXT Oncology | Irving | Texas | 75039 | Recruiting |
| NEXT Oncology | Fairfax | Virginia | 22031 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06014658, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 2, 2026 · Synced Oct 2, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06014658 live on ClinicalTrials.gov.