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Tests treatment safety and results for Prostate Cancer Castration-resistant Prostate Cancer
Official title Phase 1/2 Dose Finding, Safety and PK Study in Advanced Refractory Solid Tumors
ClinicalTrials.gov ID: NCT07145255
What this study is testing
What is ADC?
ADC is an investigational medicine, being studied as a potential treatment for prostate cancer castration-resistant prostate 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 multicenter, open-label FIH, Phase 1a (dose escalation), Phase 1b (dose expansion) and Phase 2 study in patients with advanced metastatic solid tumors refractory to standard treatment.
- 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
- Patients are eligible to be included in the study only if all of the following criteria apply:
- 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...
- Must be nonlactating and have a negative serum (preferred) or urine pregnancy test results within 72 hours prior to the first dose of MBRC-201.
You likely can't join if
- Patients are excluded from the study if any of the following criteria apply:
- History of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed...
- Non-melanoma skin cancer considered completely cured;
- Localized prostate cancer treated with curative intent with no evidence of progression;
- Low-risk or very low-risk (per standard clinical guidelines) localized prostate cancer under active surveillance without immediate intent to treat;
- Malignancy that is otherwise considered cured with minimal risk of recurrence.
See the full eligibility criteria
Who can join
- Patients are eligible to be included in the study only if all of the following criteria apply:
- 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 patients of childbearing potential under the...
- Must be nonlactating and have a negative serum (preferred) or urine pregnancy test results within 72 hours prior to the first dose of MBRC-201.
- Must agree not to try to become pregnant during the study and for at least 6 months after the final dose of MBRC-201
- Must agree to practice 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...
- Male patients whose partners are of childbearing potential must agree to use effective contraception (must agree to use 2 forms of contraception, 1 of which must be a barrier method) (Section 10.4) for the duration 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 (except...
- Availability of a tumor tissue sample (formalin-fixed paraffin-embedded [FFPE]) must be confirmed if feasible. Patients without tumor sample may be eligible with medical monitor approval. Tumor biopsies are not required...
- For Dose Escalation (Phase 1a), patients may have evaluable disease or measurable disease according to Response Evaluation Criteria in Solid Tumor (RECIST) v1.1. For both Dose Expansion (Phase 1b) and Phase 2, patients...
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Life expectancy ≥ 3 months
- Patient must have adequate organ and marrow function as defined below.
- Absolute neutrophil count (ANC) ≥ 1500/uL
- Hemoglobin (Hgb) ≥ 9 g/dL
- Platelet count ≥ 100,000/uL
- International normalized ratio (INR) \< 1.5 (or ≤ 3.0 if on therapeutic anticoagulation)
- Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min by the CKD-EPI or similar equation or as measured by 24-hour urine collection
- Total bilirubin ≤ 1.5 × ULN [or ≤ 3-times ULN for patients with Gilbert's disease or documented hepatic tumor involvement]
- ALT and AST ≤ 3 × ULN [or ≤ 5-times ULN for patients with documented hepatic tumor involvement]
What rules you out
- Patients are excluded from the study if any of the following criteria apply:
- 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:
- Non-melanoma skin cancer considered completely cured;
- Localized prostate cancer treated with curative intent with no evidence of progression;
- Low-risk or very low-risk (per standard clinical guidelines) localized prostate cancer under active surveillance without immediate intent to treat;
- Malignancy that is otherwise considered cured with minimal risk of recurrence.
- Known or suspected sensitivity to any of the ingredients of the investigational product MBRC-201.
- Active cerebral/meningeal disease related to the underlying malignancy. Patients with a history of cerebral/meningeal disease related to the underlying malignancy are allowed if prior central nervous system disease has...
- Any uncontrolled viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study drug, unless deemed not clinically significant by the investigator (e.g., onychomycosis). Routine antimicrobial...
- Active or symptomatic viral hepatitis, including patients with active hepatitis C infection (positive by polymerase chain reaction or on antiviral therapy for hepatitis C within the last 6 months). Patients who have...
- Patients with HIV infection with 1 or more of the following:
- Acquired immunodeficiency syndrome (AIDs)-defining opportunistic infection within 6 months of the start of screening
- A change in antiretroviral therapy within 3 months of the start of screening and viral load \> 500 copies/mL
- Receiving antiretroviral therapy that may interfere with study drug
- CD4 count \< 350 at screening
- 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
- 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...
- 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 or patients with risk factors for Torsades de pointes
- Uncontrolled Inflammatory Bowel Disease (IBD)
- A history of (non-infectious) ILD/pneumonitis requiring steroid therapy, or active ILD/pneumonitis, or clinically suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
- Uncontrolled autoimmune disease or syndrome
- Active ocular surface disease at screening, including confluent superficial keratitis, cornea epithelial defect, corneal ulcer or stromal opacity or any components of the ophthalmologic history which, in the...
- 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...
- Use of any investigational drug within 14 days prior to the first dose of study drug.
- For Phase 1b and Phase 2: prior treatment with an ADC with a camptothecin (CPT) payload, such as Enhertu (trastuzumab deruxtecan), Datroway (datopotamab deruxtecan), or Trodelvy (sacituzumab govitecan). Prior treatment...
- Current use of any prohibited concomitant medication(s).
- Major surgery within 28 days prior to first dose of study drug.
- Patients who have not recovered from AEs due to prior anticancer therapy (i.e., have residual toxicities \> Grade 1) with the exception of alopecia
- 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.
- Condition or situation which, based on Investigator or Sponsor assessment, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the...
- Other serious underlying medical condition that would impair the patient's ability to receive or tolerate the planned treatment and follow-up
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
- Grand Rapids, Michigan, United States
- East Brunswick, New Jersey, United States
- Irving, Texas, United States
- San Antonio, Texas, United States
- West Valley City, Utah, 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; Grand Rapids, Michigan, United States; East Brunswick, New Jersey, United States; Irving, Texas, United States; San Antonio, Texas, United States; West Valley City, Utah, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.