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Tests treatment safety and results for Cancer
Official title Safety, PK, and Preliminary Efficacy of MBRC-101 in Advanced Refractory Solid Tumors
ClinicalTrials.gov ID: NCT06014658
What this study is testing
What is Antibody-Drug Conjugate?
Antibody-Drug Conjugate is an investigational medicine, being studied as a potential treatment for cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Provide written consent on an Informed Consent Form (ICF), approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior...
- 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...
- 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...
- Have a histologic or cytologic diagnosis of malignant solid tumor for which there are no standard of care treatment options known to confer a...
You likely can't join if
- 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...
- Strong CYP3A or inducers within 14 days prior to the first dose of study drug. 8\. 7. Thromboembolic events and/or bleeding disorders 14 days (e.g...
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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. A. For...
- 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...
- 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...
- 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): A. Absolute neutrophil count (ANC) ≥ 1.0 × 109/L B. Platelet count ≥ 100 ×...
- 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...
- 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...
- Strong CYP3A or inducers within 14 days prior to the first dose of study drug. 8\. 7. Thromboembolic events and/or bleeding disorders 14 days (e.g., venous thromboembolism [VTE] or pulmonary embolism [or PE]) prior to...
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
- Aurora, Colorado, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Lafayette, Indiana, United States
- Detroit, Michigan, United States
- Las Vegas, Nevada, United States
- New Brunswick, New Jersey, United States
- New York, New York, United States
- Huntersville, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- Charleston, South Carolina, United States
- Greenville, South Carolina, United States
- Austin, Texas, United States
- Irving, Texas, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States; Aurora, Colorado, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States; Lafayette, Indiana, United States; Detroit, Michigan, United States and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.