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Tests treatment safety and results for Gastric Adenocarcinoma
Official title Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects With Solid Tumors
ClinicalTrials.gov ID: NCT07021066
What this study is testing
What is BL-M05D1?
BL-M05D1 is an investigational medicine, being studied as a potential treatment for gastric adenocarcinoma.
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, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects with Advanced or Metastatic Solid Tumors.
- Phase 1: an early, usually small safety study
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
- Signed the informed consent form voluntarily and agreed to follow the program requirements.
- Age ≥18 years.
- Life expectancy of ≥3 months.
- Dose Escalation and Dose Finding (Parts 1 and 2): Documented locally advanced or metastatic solid tumor(s) that are known to potentially express...
- Gastric or gastroesophageal junction (G/GEJ) adenocarcinoma (AC): Participants with CLDN18.2, HER2, PD-L1, and/or microsatellite instability high...
You likely can't join if
- Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, targeted therapy (including small-molecule inhibitor of tyrosine kinase), or...
- Participants with history of severe heart disease such as symptomatic congestive heart failure (CHF) Grade ≥2 (CTCAE v5.0), New York Heart...
- Participants with prolonged QT interval corrected (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...
- Participants with other prior malignancies. Exceptions: Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in...
- Participants with advanced or clinically significant lung diseases such as poorly controlled chronic obstructive pulmonary disease (COPD) or asthma...
See the full eligibility criteria
Who can join
- Signed the informed consent form voluntarily and agreed to follow the program requirements.
- Age ≥18 years.
- Life expectancy of ≥3 months.
- Dose Escalation and Dose Finding (Parts 1 and 2): Documented locally advanced or metastatic solid tumor(s) that are known to potentially express CLDN18.2, as defined below, that have recurred or progressed on at least 1...
- Gastric or gastroesophageal junction (G/GEJ) adenocarcinoma (AC): Participants with CLDN18.2, HER2, PD-L1, and/or microsatellite instability high (MSI-H)/mismatch repair deficiency (dMMR) positive tumors must have...
- Pancreatic ductal AC (PDAC): Participants who have received at least 1 line of standard therapy.
- Esophageal AC (EAC): Participants with HER2, PD-L1, and/or MSI-H/dMMR positive tumors must have received targeted treatment in their prior lines of therapy.
- Biliary tract cancers (BTCs): Participants with HER2 overexpression, NTRK fusions, KRAS mutations, IDH1 mutations, FGFR2 fusions, BRAF mutations, and/or MSI-H/ dMMR positive tumors must have received targeted treatment...
- Other solid tumors not specified above may be included if they have documented CLDN18.2 expression by IHC (1+). As applicable per standard of care, participants with HER2 and/or PD-L1 positive tumors must have received...
- Agree to provide most recent existing tumor samples (formalin-fixed paraffin-embedded [FFPE] tissue block or slides) from primary or metastatic sites (see details in Section 7.1.1) for tissue-based evaluation of...
- At least 1 measurable lesion based on RECIST 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. Exceptions: Alopecia and endocrinopathies controlled by replacement therapy must be Grade ≤2.
- No serious cardiac dysfunction, left ventricular ejection fraction ≥50%.
- Adequate organ function before enrollment, defined as follows:
- Marrow function: absolute neutrophil count (ANC) ≥1.5×109/L, platelet (PLT) count ≥100×109/L, hemoglobin (Hb) ≥9.0 g/dL (blood transfusion, platelet transfusion, erythropoietin (EPO), hematopoiesis agents, and G-CSF use...
- 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...
- Renal function: creatinine clearance (CrCl) ≥60 mL/min (Cockcroft-Gault equation) or estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73 m2 (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] creatinine...
- 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...
- Sexually active fertile participants and their partners must agree to use highly effective methods of contraception (defined in Section 17.5 [Appendix E]) during the course of the study and after the last dose of study...
- Individuals of childbearing potential (IOCBP) must have a negative serum pregnancy test at screening and must be nonlactating. Female participants are considered IOCBP unless one of the following criteria are met...
- All participants must be willing to receive prophylactic G-CSF during their time on study (see Section 6.3.4.5). Additional for Dose Optimization (Part 3)
- PDAC Expansion Arm: Participants who have received at least 1 line of standard therapy and no more than 2 lines of systemic therapy (refer to Section 6.3.1). Note: Participants who have received prior treatment with a...
- Basket Expansion Arm: Documented locally advanced or metastatic solid tumor(s) that are known to potentially express CLDN18.2 as defined below that have recurred or progressed on at least 1 line of prior systemic...
- G/GEJ AC: Participants with CLDN18.2, HER2, PD-L1, and/or MSI-H/dMMR positive tumors must have received targeted treatment in their prior lines of therapy.
- G/GEJ AC and BTCs: Participants who have received prior treatment with an anti-CLDN18.2 antibody must be able and willing to provide tissue sample obtained following treatment with anti-CLDN18.2 agent.
- BTCs: Participants with HER2 overexpression, NTRK fusions, KRAS mutations, IDH1 mutations, FGFR2 fusions, BRAF mutations, and/or MSI-H/dMMR positive tumors must have received targeted treatment in their prior lines of...
What rules you out
- Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, targeted therapy (including small-molecule inhibitor of tyrosine kinase), or 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 v5.0), New York Heart Association (NYHA) Grade ≥2 heart failure at any time, or history of myocardial...
- Participants with prolonged QT interval corrected (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, or Hashimoto's thyroiditis...
- Participants with other prior malignancies. Exceptions: 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 advanced or clinically significant lung diseases such as poorly controlled chronic obstructive pulmonary disease (COPD) or asthma, restrictive lung disease, or pulmonary hypertension.
- Participants who have a history of noninfectious interstitial lung disease (ILD)/pneumonitis that required treatment with steroids or 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, pulmonary embolism) within 6 months before enrollment. Exception: Those who are clinically stable and receiving treatment with adequate anticoagulant...
- Participants with primary tumors in the central nervous system (CNS), or active or untreated CNS metastases and/or carcinomatous meningitis. Exception: Participants 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, human-mouse chimeric antibodies, or any of the components of BL-M05D1.
- Participants who are receiving treatment with systemic glucocorticoids \>10 mg/day equivalent of prednisone. Exceptions:
- Treatment of COPD and infusion-related reactions (IRRs) is permitted.
- Treatment with low-dose glucocorticoids (≤10 mg/day equivalent of prednisone), including antiemetics, is permitted.
- The chronic use of topical, inhaled, and locally injected steroids is permitted.
- Participants with known or suspected human immunodeficiency virus (HIV) infection (HIV antibody positive). Exceptions: Participants are allowed to participate if all the following criteria are met:
- undetectable HIV RNA and CD4 count ≥350 cells/μL at screening;
- no acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within 12 months prior to screening; and
- 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 known active hepatitis B virus (HBV) infection (positive hepatitis B surface antigen [HBsAg] test). Exceptions: Participants with a chronic inactive HBV infection are eligible if all the following...
- HBV DNA viral load \<500 IU/mL;
- normal AST and ALT, or if liver metastasis is present, AST and ALT \<3 × ULN that are not attributed to HBV infection; and
- on antiviral treatment as clinically indicated.
- Participants with known active hepatitis C virus (HCV) infection (HCV antibody positive and HCV-RNA \> the lower limit of detection). Exception: Participants with a positive anti-HCV antibody are eligible only if...
- Participants with known active tuberculosis.
- Participants with active infections that require IV antibiotic, antiviral, or antifungal treatment, such as severe pneumonia, bacteremia, or sepsis, within 1 week prior to first dose of study treatment. Exception...
- 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 Optimization Only: Prior treatment with any topoisomerase inhibitor ADC.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Los Angeles, California, United States
- Aurora, Colorado, United States
- New Haven, Connecticut, United States
- New Orleans, Louisiana, United States
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
- Hackensack, New Jersey, United States
- New York, New York, United States
- Nashville, Tennessee, United States
- Austin, Texas, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Temple, Texas, 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 Phoenix, Arizona, United States; Scottsdale, Arizona, United States; Los Angeles, California, United States; Aurora, Colorado, United States; New Haven, Connecticut, United States; New Orleans, Louisiana, 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.