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CancerPhase 1/2NCT06014658

Safety, PK, and Preliminary Efficacy of MBRC-101 in Advanced Refractory Solid Tumors

A Phase 1/2 study testing Antibody-Drug Conjugate in people with Cancer, run by MBrace Therapeutics at 17 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
Antibody-Drug Conjugate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
17 sitesUnited States
Study dates
7 Nov 2023to Nov 2026
Phase
Phase 1/2
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

  • Provide written consent on an Informed Consent Form (ICF), approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to any study-specific evaluation. Patients should have the ability to read and understand the ICF, ask for any clarifications from the study staff, and be able to comply with all planned study procedures.
  • 18 years of age or older at the time of informed consent.
  • Female patients must be at least 2 years postmenopausal (defined as 2 years without menses), surgically sterile (at least 6 months prior to dosing; must be documented) or practicing effective contraception (must agree to use 2 forms of contraception, 1 of which must be a barrier method) and willing to continue to use effective contraception for the duration of study participation and for 6 months after the final dose of study drug. Female patients must be nonlactating and have a negative serum pregnancy test result at screening and baseline.
  • Male patients must agree to use effective contraception (must agree to use 2 forms of contraception, 1 of which must be a barrier method) for the duration of study participation and for 6 months after the final dose of study drug.
  • Have a histologic or cytologic diagnosis of malignant solid tumor for which there are no standard of care treatment options known to confer a clinical benefit or for which the patient is ineligible or declines.
  • For Phase 1 dose escalation: histologic or cytologic diagnosis of malignant solid tumor of any type. The Sponsor may remove specific tumor indications based on emerging, real-time study data.
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  • For Phase 1b dose expansion:
  • Cohort A: Histologic or cytologic diagnosis of NSLC (adenocarcinoma and SCC).
  • Cohort B: Histologic or cytologic diagnosis of TNBC or HR positive, HER2 negative breast cancer.
  • Cohort C: Histologic or cytologic diagnosis of the following advanced metastatic solid tumors refractory to standard treatment: pancreatic adenocarcinoma, gastric adenocarcinoma, hepatocellular carcinoma, ovarian adenocarcinoma, and squamous cell carcinoma including, but not limited to, primary malignancies of the head and neck, esophagus, cervix, and skin. The Sponsor may add or remove specific tumor indications based on emerging, real-time study results.
  • Availability of a tumor tissue sample (formalin-fixed paraffin embedded [FFPE]) must be confirmed for analysis of EphA5 expression based on IHC. Tumor biopsies are not required and should not be performed to assess eligibility.
  • For Dose Escalation (Phase 1) and Dose Expansion (Phase 1b), tumor EphA5 expression will not be required for enrollment.
  • For Dose Escalation (Phase 1), patients may have evaluable disease or measurable disease according to RECIST v1.1). For Dose Expansion (Phase 1b) and Phase 2, patients must have measurable disease according to RECIST v1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  • Life expectancy ≥ 3 months as assessed by the investigator.
  • Hematologic function, as follows (no red blood cell [RBC] or platelet transfusions are allowed within 14 days of the first dose of MBRC-101):
  • Absolute neutrophil count (ANC) ≥ 1.0 × 109/L B. Platelet count ≥ 100 × 109/L C. Hemoglobin ≥ 9 g/dL
  • Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min by the CKD-EPI or similar equation or as measured by 24-hour urine collection.
  • Total bilirubin ≤ 1.5 × upper limit normal (ULN).
  • AST ≤ 3.0 × ULN.
  • ALT ≤ 3.0 × ULN.
  • International normalised ratio (INR) < 1.5 (or ≤ 3.0 if on therapeutic anticoagulation).
  • Treatment with other agents for cancer, if received, must have been discontinued ≥ 2 weeks prior to first dose of study drug.
  • Prior ADC therapy is allowed. Prior agents conjugated to MMAE are allowed for Phase 1 but not for Phase 1b or Phase 2. These exclusionary agents include brentuximab vedotin, polatuzumab vedotin, enfortumab vedotin, disitamab vedotin, tisotumab vedotin, and any MMAE-conjugated agents approved subsequent to the publication of this Protocol.

Who cannot join

  • Preexisting sensory neuropathy Grade ≥ 2.
  • Preexisting motor neuropathy Grade ≥ 2.
  • Uncontrolled central nervous system metastases.
  • Use of any investigational drug within 14 days prior to the first dose of study drug.
  • Any anticancer therapy within 14 days prior to the first dose of study drug, including: small molecules, immunotherapy, chemotherapy, monoclonal antibody therapy, radiotherapy, or any other agents to treat cancer (anti-hormonal therapy given for advanced prostate cancer or as adjuvant therapy for early stage, hormone receptor (HR) positive breast cancer is not considered cancer therapy for the purpose of this Protocol).
  • Strong CYP3A or inducers within 14 days prior to the first dose of study drug.
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  • 8. 7. Thromboembolic events and/or bleeding disorders 14 days (e.g., venous thromboembolism [VTE] or pulmonary embolism [or PE]) prior to the first dose of study drug.
  • 8. Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms (including congestive heart failure) consistent with New York Heart Association Class 3-4 within 6 months prior to the first dose of MBRC-101.
  • 9. A baseline QT (time from the beginning of the Q wave to the end of the T wave) interval as corrected by Fridericia's formula (QTcF) > 470 msec.
  • 10. Human immunodeficiency virus (HIV) infection with 1 or more of the following: A. Acquired immunodeficiency syndrome (AIDs)-defining opportunistic infection within 6 months of the start of screening; B. A change in antiretroviral therapy within 3 months of the start of screening and viral load > 500 copies/mL; C. Receiving antiretroviral therapy that may interfere with study drug; D. CD4 count < 350 at screening. 11. Active or symptomatic viral hepatitis. Patients who have been properly treated for hepatitis C infection can be included if they do not have active hepatitis C.
  • 12. Known sensitivity to any of the ingredients of the investigational product MBRC-101.
  • 13. Major surgery within 28 days prior to first dose of study drug. 14. History of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Allowed exceptions are patients with: A. Non-melanoma skin cancer considered completely cured; B. Localized prostate cancer treated with curative intent with no evidence of progression; C. Low-risk or very low-risk (per standard clinical guidelines) localized prostate cancer under active surveillance without immediate intent to treat; D. Malignancy that is otherwise considered cured with minimal risk of recurrence.
  • 15. Currently receiving systemic antimicrobial treatment for active infection (bacterial, viral, or fungal) at the time of first dose of MBRC-101. Routine antimicrobial prophylaxis is permitted.
  • 16. Condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study.
  • 17. Any medical, psychiatric, addictive, or other kind of disorder which compromises the ability of the patient to give written informed consent and/or to comply with procedures.
  • 18. Active ocular surface disease at baseline or any components of the ophthalmologic history which, in the investigator's opinion, may place the patient at significant risk.

Trial locations and contacts

17 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Kellogg Parsons, MD, M.H.S. contact

858-703-8086

clinicalsupport@mbracetrx.com

17 sites in 1 country

United States17 sites, 15 recruiting

  • Winship Cancer Institute, Emory University

    Atlanta, Georgia, 30322

    Ticiana Leal, MD

    Recruiting

  • University of Colorado, Anschutz Cancer Pavilion (ACP(

    Aurora, Colorado, 80045

    Jennifer R Diamond, MD

    Recruiting

  • NEXT Oncology

    Austin, Texas, 78758

    Andrae Vandross, MD

    Recruiting

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29425

    Mariam Alexander, MD

    Recruiting

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

    Nan Chen, MD

    Recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

    Khalil Choucair, MD

    Recruiting

  • NEXT Oncology

    Fairfax, Virginia, 22031

    Adham Salkeni, MD

    Recruiting

  • PRISMA Health, Institute for Translational Oncology

    Greenville, South Carolina, 29605

    William J Edenfield, MD

    Recruiting

  • Carolina BioOncology Institute

    Huntersville, North Carolina, 28078

    Active, not recruiting

  • NEXT Oncology

    Irving, Texas, 75039

    Shiraj Sen, MD

    Recruiting

  • Horizon Oncology Research

    Lafayette, Indiana, 47905

    Completed

  • Comprehensive Cancer Center of Nevada

    Las Vegas, Nevada, 89169

    Kyaw Z Thein, MD

    Recruiting

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

    Sanjay Goel, MD

    Sanjay Goel, MD

    Recruiting

  • Columbia University Irving Medical Center

    New York, New York, 10032

    Linda Wu, MD

    Recruiting

  • University of Pennsylvania, Abramson Cancer Center

    Philadelphia, Pennsylvania, 19014

    Kim Reiss-Binder, MD

    Recruiting

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

    Martin Edelman, MD

    Recruiting

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94158

    Phu Lam, Phu.Lam@ucsf.edu

    Pam Munster, MD

    Recruiting

Other trials in United States

About this study

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

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.

Read the detailed description

Phase 1, dose escalation, will enroll approximately 30 patients with advanced or metastatic solid tumors refractory to standard therapy. EphA5 expression will not be required for enrollment into Phase 1 but will be assessed retrospectively.

Phase1b, the dose expansion phase will evaluate the safety and preliminary clinical activity of MBRC-101 at potential OBRDs and dosing regimens in patients with advanced or metastatic solid tumors refractory to standard therapy. Phase 1b will enroll 3 expansion cohorts of ≈ 20 patients per cohort (n ≈ 60 total).

The Phase 2 portion will begin when the RP2D has been determined from Phase 1b and all Phase 1b patients have completed at least two cycles of treatment or have discontinued from the study prior to completing two cycles of treatment. Phase 2 will evaluate anti-tumor activity and safety of the RP2D determined during Phase 1b. Phase 2 will focus on a specific tumor type identified during Phase 1/1b and will enroll approximately 30 patients.

Safety will be monitored by the Safety Review Committee (SRC) at each dose escalation in Phase 1 and at regular intervals throughout Phase 1b and Phase 2.

Overall Response Rate (ORR), Progression Free Survival (PFS), Response Rate (RR), Overall Survival (OS), Disease Control Rate (DCR), and Complete and Partial response (CR and PR) will be used to evaluate efficacy per RECIST v1.1 criteria based on the results of positron emission tomography and computed tomography (PET-CT), computerized tomography (CT), and magnetic resonance imaging (MRI) scans.

Conditions
Cancer
Being tested
Antibody-Drug Conjugate
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Antibody-Drug ConjugateDrug

    MBRC-101: AN ANTI-EPHA5 MONOMETHYL AURISTATIN E (MMAE) ANTIBODY DRUG CONJUGATE

Study groups in NCT06014658
Study groupRoleWhat they receive
Phase 1 Dose EscalationExperimentalNot described
Receives: Drug: Antibody-Drug Conjugate
Phase 1b ExpansionExperimentalNot described
Receives: Drug: Antibody-Drug Conjugate
Phase 2ExperimentalNot described
Receives: Drug: Antibody-Drug Conjugate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of treatment-emergent adverse events (TEAEs)

    TEAEs will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v.5.0.

    Measured: Up to 24 Months

  2. Occurrence of dose limiting toxicities (DLTs) during the DLT evaluation period

    The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.

    Measured: 21 Days

Secondary outcomes (4)

  1. Objective Response Rate (ORR)

    ORR is defined as the percentage of participants who have a partial response (PR) or better according to the response evaluation criteria in solid tumors (RECIST) version 1.1.

    Measured: Up to 24 Months

  2. Duration of Response (DOR)

    DOR will be calculated among responders (PR or better) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease per RECIST version 1.1 response criteria, or death due to any cause, whichever occurs first.

    Measured: Up to 24 Months

  3. Progression-Free Survival (PFS)

    PFS will be calculated from the date of first dose of MBRC-101 to the date of first documented evidence of progressive disease as defined by RECIST version 1.1 response criteria or death due to any cause, whichever occurs first.

    Measured: Up to 24 Months

  4. Disease Control Rate (DCR)

    DCR will be defined as the proportion of patients with best overall response of Complete Response, Partial Response, or Stable Disease (SD) according to the response evaluation criteria in solid tumors (RECIST) version 1.1.

    Measured: Up to 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2023
  2. Study start7 Nov 2023
  3. Primary completionJul 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06014658
Sponsor's protocol ID
MBRC-101-001
Status last verified
Mar 2025
First submitted
1 Aug 2023
Last updated
2 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Staquicini FI, Tang FH, de Oliveira V, Kim SY, Chen ER, Markosian C, Staquicini DI, Wu Y, Parsons JK, Barnhart KF, Alley SC, Chen I, Arap W, Pasqualini R. First-generation and preclinical evaluation of an EphA5-targeted antibody-drug conjugate in solid tumors. J Clin Invest. 2025 Jul 15;135(14):e188492. doi: 10.1172/JCI188492. eCollection 2025 Jul 15.

    PubMed 40662373

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Antibody-Drug Conjugate in people with Cancer, run by MBrace Therapeutics at 17 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 24 inclusion and 16 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 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Kellogg Parsons, MD, M.H.S. (858-703-8086, clinicalsupport@mbracetrx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of treatment-emergent adverse events (TEAEs) (time frame: Up to 24 Months). The study lists 2 primary outcomes in all. 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 NCT06014658, 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 2 Mar 2026.

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