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New treatment option for Endometrial Cancer
Official title Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors
ClinicalTrials.gov ID: NCT06293898
What this study is testing
What is BL-M07D1?
BL-M07D1 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for endometrial 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
- The objective of this study is to evaluate the safety, tolerability, and efficacy of BL-M07D1 in patients with HER2 expressing advanced tumors.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
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
- Participants must meet all the following to be eligible for participation in this study:
- Signed the informed consent form voluntarily and agreed to follow the program requirements.
- Either sex
- Age: ≥18 years
- Life expectancy of ≥3 months
You likely can't join if
- Participants who meet any of the following criteria will not be eligible for participation in this study:
- Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, targeted therapy (including small molecule inhibitor of tyrosine kinase), and...
- Participants with history of severe heart disease, such as symptomatic congestive heart failure (CHF) ≥ Grade 2 (CTCAE 5.0), New York Heart...
- Participants with prolonged QT interval corrected Fridericia formula ([QTcF]\>470 msec), complete left bundle branch block, Grade 3 atrioventricular...
- Active autoimmune diseases and inflammatory diseases, such as systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid...
- Participants with other prior malignancies except for: basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or carcinoma in situ...
See the full eligibility criteria
Who can join
- Participants must meet all the following to be eligible for participation in this study:
- Signed the informed consent form voluntarily and agreed to follow the program requirements.
- Either sex
- Age: ≥18 years
- Life expectancy of ≥3 months
- For Dose Escalation and Dose Finding: Documented locally advanced or metastatic HER2-expressing (IHC 1+ to 3+ and/or HER2 gene amplification or activating mutation [see Table 17-5] in tumor specimen by ISH or NGS) solid...
- Cohort 1: Participants with HER2 expression in endometrial cancers
- Cohort 2: Participants with HER2 expression in cervical cancers
- Cohort 3: Participants with HER2 expression in ovarian cancers, including fallopian tube cancer and primary peritoneal cancer
- Cohort 4: Participants with HER2 expression in urothelial cancers
- Cohort 5: Participants with HER2 expression in biliary tract cancers
- Cohort 6: Participants with HER2 expression in breast cancer
- Cohort 7: Participants with HER2 expression in lung cancer
- Cohort 8: Participants with HER2 expression in gastric, esophageal, or gastroesophageal junction (GEJ) cancers
- Cohort 9: Participants with HER2 expression in other solid tumors as approved by the medical monitor Note: For indications in which a HER2-directed therapy is approved, the approved treatment is recommended although not...
- Agree to provide most recent existing tumor samples (formalin-fixed paraffin-embedded [FFPE] tissue block or slides) from primary or metastatic sites for tissue-based IHC staining to centrally determine HER2 expression...
- In dose escalation and dose finding: archival tissue or fresh biopsy. If no archival tissue is available or it is not possible to obtain a fresh tissue biopsy, medical monitor approval is required to screen participant;
- In dose expansion: an FFPE block or slides from fresh biopsy or the most recent archival tissue is required.
- At least one measurable lesion based on RECIST (Response Evaluation Criteria in Solid Tumors) V1.1
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1
- Toxicity of previous antitumor therapy has returned to Grade ≤1 as defined by the National Cancer Institute (NCI) CTCAE V5.0, except for alopecia and endocrinopathies controlled by replacement therapy that must be Grade...
- No serious cardiac dysfunction, left ventricular ejection fraction ≥50%
- Adequate organ function before enrollment, defined as:
- Marrow function: Absolute neutrophil count (ANC) ≥1.5×10\^9/L, platelet (PLT) count ≥100×10\^9 /L, hemoglobin (Hb) ≥9.0 g/dL [blood transfusion, PLT transfusion, erythropoietin, hematopoiesis agents, and granulocyte...
- Hepatic function: Total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN) (≤3×ULN for participants with Gilbert's syndrome or liver metastasis at baseline), aspartate aminotransferase (AST) and alanine aminotransferase...
- Renal function:
- In dose escalation and dose finding: Creatinine (Cr) clearance ≥50 mL/minute (Cockcroft-Gault equation) or estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73 m\^2 (Chronic Kidney Disease Epidemiology...
- In dose expansion: Cr clearance ≥40 mL/minute (Cockcroft-Gault equation) or eGFR ≥40 mL/min/1.73 m\^2 (CKD-EPI equation)
- Coagulation parameters: International Normalized Ratio (INR) ≤1.5×ULN, and activated partial thromboplastin time (aPTT) ≤1.5×ULN, unless receiving anticoagulation therapy with prothrombin time and aPTT levels within the...
- Urine protein ≤2+ or ≤1000 mg/24 hours (in dose escalation and dose finding only)
- Sexually active fertile participants and their partners must agree to use highly effective methods of contraception (defined in Appendix D) during the course of the study and for a washout period after the last dose of...
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and must be nonlactating. Female participants are considered WOCBP unless one of the following criteria are met: documented...
- For participants with urothelial carcinoma (Part A: assigned by chance Doses):
- Histologically confirmed advanced or unresectable HER2-expressing (as defined in Inclusion Criterion #5) urothelial carcinoma of the upper or lower urinary tract, not amenable to curative surgery or radiation. Mixed...
- Participants with progression or recurrence following receipt of an ADC (eg, enfortumab vedotin or disitamab vedotin) and anti-PD1/PD-L1 therapy (either as a combination regimen or as separate lines of therapy) in the...
- Multiple Indications (Part B: Basket Dosing): Has documented locally advanced or metastatic HER2-expressing (as defined in Inclusion Criterion #5) solid tumor(s) not amenable to curative surgery or radiation and has...
- Participants with HER2 expression in endometrial cancer
- Participants with HER2 expression in cervical cancer
- Participants with HER2 expression in ovarian cancer, including fallopian tube cancer and primary peritoneal cancer
- Participants with HER2 expression in breast cancer, status post-trastuzumab deruxtecan
- Participants with HER2 expression in breast cancer, trastuzumab deruxtecan-naïve
- Participants with HER2 expression in gastric, esophageal, or GEJ cancers
- Participants deemed at high-risk for infection, including those with an indwelling catheter or ostomy, must be willing to receive prophylactic G-CSF during their time on study (see Section 6.3.3.5).
What rules you out
- Participants who meet any of the following criteria will not be eligible for participation in this study:
- Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, targeted therapy (including small molecule inhibitor of tyrosine kinase), and other antitumor therapy within 4 weeks or 5 half-lives (whichever is...
- Participants with history of severe heart disease, such as symptomatic congestive heart failure (CHF) ≥ Grade 2 (CTCAE 5.0), New York Heart Association (NYHA) ≥ Grade 2 heart failure at any time, or history of...
- Participants with prolonged QT interval corrected Fridericia formula ([QTcF]\>470 msec), complete left bundle branch block, Grade 3 atrioventricular block
- Active autoimmune diseases and inflammatory diseases, such as systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory bowel disease, and Hashimoto's thyroiditis, etc...
- Participants with other prior malignancies except for: basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or carcinoma in situ after adequate resection, or other malignancy treated with curative...
- Participants with poorly controlled hypertension by 2 types of antihypertensive drugs (systolic blood pressure \>150 mmHg or diastolic blood pressure \>100 mmHg)
- Participants with advanced or clinically significant lung diseases, such as poorly controlled chronic obstructive pulmonary disease and asthma, restrictive lung disease, pulmonary hypertension, etc.
- Participants who have a history of noninfectious interstitial lung disease (ILD)/ pneumonitis that required treatment with steroids, have current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out...
- Participants with stroke or transient ischemic attack (TIA) within 6 months before enrollment
- Participants with a thromboembolic event (eg, deep vein thrombosis or pulmonary embolism) within 6 months before enrollment except for those who are clinically stable and receiving treatment with adequate anticoagulant...
- Participants with primary tumors in the central nervous system (CNS) and active or untreated CNS metastases and/or carcinomatous meningitis should be excluded. Patients with previously treated brain metastases may...
- Participants with pre-existing Grade ≥2 peripheral neuropathy
- Participants who have a history of anaphylaxis or severe hypersensitivity to recombinant humanized antibodies or human-mouse chimeric antibodies or any of the components of BL-M07D1
- Participants who are receiving treatment with systemic glucocorticoids \>10 mg/day equivalent of prednisone, except for the treatment of chronic obstructive pulmonary disease, antiemetic, infusion reactions; however...
- Participants who have received treatment with anthracyclines with a cumulative dose exceeding 360 mg/m\^2
- Participants with known human immunodeficiency virus (HIV) infection (HIV antibody positive). Participants who are HIV positive are allowed to participate if all the following criteria are met:
- Undetectable HIV RNA and CD4 count ≥ 350 cells/μL at screening;
- No AIDS-defining opportunistic infection within 12 months prior to screening;
- On stable antiretroviral therapy (ART) for at least 4 weeks prior to enrollment with projected continuation of ART as clinically indicated while on the study.
- Participants with active hepatitis B virus (HBV) infection (positive HBsAg test). Participants with a chronic inactive HBV infection are eligible if all the following criteria are met:
- Have an HBV DNA viral load \< 500 IU/mL;
- Have normal AST and ALT, OR if liver metastasis is present, have AST and ALT \<3×ULN which are not attributed to HBV infection;
- Are on antiviral treatment, as clinically indicated.
- Participants with active hepatitis C virus (HCV) infection (HCV antibody positive and HCV RNA \> the lower limit of detection). Participants with a positive anti-HCV antibody are eligible only if polymerase chain...
- Participants with known active tuberculosis
- Participants with active infections requiring IV antibiotic, antiviral, or antifungal treatment, such as severe pneumonia, bacteremia, sepsis, etc., within 1 week prior to first dose of study treatment. Participants on...
- Participants who are pregnant, breastfeeding, or planning to become pregnant during the study
- Other conditions that the investigator or sponsor believes are not suitable for participating in this clinical trial.
- For Dose Expansion Only: Prior treatment with any topoisomerase inhibitor ADC. If the topoisomerase I ADC is sacituzumab govitecan, prior discussion with the medical monitor is required for potential inclusion
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Duarte, California, United States
- Los Angeles, California, United States
- San Diego, California, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Augusta, Georgia, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Mineola, New York, United States
- New York, New York, United States
- Portland, Oregon, United States
- Nashville, Tennessee, United States
- Houston, 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 Birmingham, Alabama, United States; Duarte, California, United States; Los Angeles, California, United States; San Diego, California, United States; Miami, Florida, United States; Orlando, Florida, United States and 10 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.