A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M07D1 in Subjects With HER2 Expressing Advanced Malignant Solid Tumors

Plain English Summary

Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors is a Phase 1 clinical trial sponsored by SystImmune Inc. studying Endometrial Cancer, Cervical Cancer, Ovarian Cancer, Urothelial Carcinoma, Biliary Tract Cancer, Breast Cancer, Lung Cancer, Gastric Cancer, Gastroesophageal-junction Cancer, Esophageal Cancer. This trial tests a new drug called BL-M07D1 for advanced cancers that have a specific protein (HER2) on their surface. It is for adults with various advanced solid tumors, including endometrial, cervical, ovarian, breast, lung, and others, who have already tried at least two standard treatments. Participants will receive BL-M07D1 through an IV infusion every three weeks, and their health will be closely monitored. Alternative treatments depend on the specific cancer type and previous treatments, and may include chemotherapy, immunotherapy, or targeted therapies. The trial aims to enroll 280 participants.

Official Summary

The objective of this study is to evaluate the safety, tolerability, and efficacy of BL-M07D1 in patients with HER2 expressing advanced tumors.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults aged 18 and older with advanced cancers that test positive for HER2. Patients must have tried at least two prior treatments for their cancer, or have cancer that is resistant to standard care. Individuals with a life expectancy of at least 3 months and good overall health, including normal organ function and heart function, can participate. People with active autoimmune diseases, severe heart conditions, recent blood clots, or untreated brain metastases are generally excluded. This trial is studying Endometrial Cancer, Cervical Cancer, Ovarian Cancer, Urothelial Carcinoma, Biliary Tract Cancer, Breast Cancer, Lung Cancer, Gastric Cancer, Gastroesophageal-junction Cancer, Esophageal Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcomes will show how safe the drug is and determine the best dose to use for future studies, helping doctors understand how well the drug might work. The specific primary outcome measures are: Summary of safety (Though study completion, an average of 24 months); To determine the maximum tolerated dose (MTD) if reached or maximum administered dose (MAD) and two or more recommended doses for dose expansion (RDEs) of BL-M07D1 (21 Days). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 1, the first major stage of clinical testing. Phase 1 trials typically involve 20-100 participants and focus on safety, dosage levels, and side effects. The primary goal is not to test whether the treatment works but to establish that it is safe enough for further testing. About 70% of Phase 1 drugs advance to Phase 2. If successful, the treatment will proceed to Phase 2 efficacy testing.

Why This Trial Matters

This trial is important because it explores a new treatment option for patients with advanced HER2-expressing cancers who have limited treatment choices. This research targets Endometrial Cancer, Cervical Cancer, Ovarian Cancer, Urothelial Carcinoma, Biliary Tract Cancer, Breast Cancer, Lung Cancer, Gastric Cancer, Gastroesophageal-junction Cancer, Esophageal Cancer, where improved treatment options are needed.

Investor Insight

This trial signals potential for a new targeted therapy in a market with significant unmet needs for HER2-positive advanced cancers, with a moderate probability of success depending on early safety an Phase 1 trials have approximately a 10% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor if your cancer is HER2-positive and if this trial is a suitable option for you. Be prepared for regular clinic visits for infusions and monitoring of your health and potential side effects. You will need to provide tumor samples for testing HER2 status and agree to use effective birth control during and after the trial. This trial is currently recruiting participants. The trial is being conducted at 17 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NON_RANDOMIZED
• Model: SEQUENTIAL
• Masking: NONE
• Enrollment: 280 participants

Interventions

• DRUG: BL-M07D1 — Drug: BL-M07D1 The study includes 3 parts: Part 1 Dose escalation. Part 2 Dose Finding non-randomized and Part 3 Dose expansion randomized. BL-M17D1 will be administered on Day 1 by intravenous infusion every 3 weeks. Other Names: BL-M07D1

Primary Outcomes

• Summary of safety (Though study completion, an average of 24 months)
• To determine the maximum tolerated dose (MTD) if reached or maximum administered dose (MAD) and two or more recommended doses for dose expansion (RDEs) of BL-M07D1 (21 Days)

Full Eligibility Criteria

Inclusion Criteria:

1. Age: ≥18 years
2. Has a life expectancy of ≥3 months
3. Has documented locally advanced or metastatic HER2expressing (IHC 1+ to 3+ and/or HER2 gene amplification or activating mutation in tumor specimen by ISH or NGS) solid tumor(s) not amenable to curative surgery or radiation and has received at least 2 lines of standard therapy, including adjuvant/neoadjuvant treatment, or whose cancer is considered refractory to the standard of care or for which no standard treatment is available, including:

   1. Cohort 1: Subjects with HER2 expression in endometrial cancers (EC)
   2. Cohort 2: Subjects with HER2 expression in cervical cancers (CC)
   3. Cohort 3: Subjects with HER2 expression in ovarian cancers (OC) including fallopian tube cancer and primary peritoneal cancer
   4. Cohort 4: Subjects with HER2 expression in urothelial cancers (UC)
   5. Cohort 5: Subjects with HER2 expression in biliary tract cancers (BTC)
   6. Cohort 6: Subjects with HER2 expression in breast cancer (BC)
   7. Cohort 7: Subjects with HER2 expression in lung cancer (LC)
   8. Cohort 8: Subjects with HER2 expression in gastric, esophageal, or gastroesophageal junction (GEJ) cancers
4. Agree to provide most recent existing tumor samples (FFPE tissue block or slides) from primary or metastatic sites for tissue-based IHC staining to centrally determine HER2 expression:

   1. 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 subject;
   2. In dose expansion: an FFPE block or slides from fresh biopsy or the most recent archival tissue is required.
5. Has at least one measurable lesion based on RECIST (Response Evaluation Criteria in Solid Tumors) V1.1
6. Has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1
7. Toxicity of previous antitumor therapy has returned to Grade ≤1
8. Has no serious cardiac dysfunction, left ventricular ejection fraction ≥50%
9. Has adequate organ function before enrollment, defined as:
10. Coagulation function: 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 intended therapeutic range
11. Urinary protein ≤2+ or ≤1000 mg/24 hours
12. For premenopausal women with childbearing potential, a pregnancy test must be taken within 7 days prior to the start of treatment. Serum or urine pregnancy test must be negative and subject must be nonlactating.
13. Must agree to use adequate contraceptive measures during the treatment and for 6 months after the end of treatment for all subjects (regardless of gender)

Exclusion Criteria:

1. 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 shorter) prior to the first administration; major surgery within 4 weeks prior to the first administration; mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration
2. Subjects with history of severe heart disease
3. Subjects with prolonged QT interval (QTc \>470 msec), complete left bundle branch block, Grade 3 atrioventricular block
4. Active autoimmune diseases and inflammatory diseases
5. Other malignant tumors diagnosed within 3 years prior to the first administration considered to be in remission
6. Subjects with poorly controlled hypertension by 2 types of antihypertensive drugs (systolic blood pressure \>150 mmHg or diastolic blood pressure \>100 mmHg)
7. Subjects with advanced or clinically significant lung diseases, such as poorly controlled chronic obstructive pulmonary disease and asthma, restrictive lung disease, pulmonary hypertension, etc.
8. Subjects with stroke, transient ischemic attack within 6 months before enrollment
9. Subjects with a thromboembolic event (eg, deep vein thrombosis \[DVT\] or pulmonary embolism \[PE\]) within 6 months before enrollment except for those who are clinically stable and receiving treatment with adequate anticoagulant therapy for at least 3 weeks before enrollment
10. Patients 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 participate provided they are clinically stable for at least 4 weeks and have no evidence of new or enlarging brain metastases and no requirements for corticosteroids 14 days prior to dosing with the investigational product (IP). Patients on low dose corticosteroids (\<20 mg prednisone or equivalent/day) may participate.
11. Subjects with pre-existing Grade ≥2 peripheral neuropathy Subjects who have a history of allergies to recombinant humanized antibodies or human-mouse chimeric an

Trial Locations

• University of Alabama Birmingham, Birmingham, Alabama, United States
• City of Hope, Duarte, California, United States
• Cedars Sinai, Los Angeles, California, United States
• Scripps Health, San Diego, California, United States
• University of Miami, Miami, Florida, United States
• Sarah Cannon Research institute - Lake Nona Florida, Orlando, Florida, United States
• Georgia Cancer Center at Augusta University, Augusta, Georgia, United States
• University of Illinois Cancer Center, Chicago, Illinois, United States
• University of Chicago Medicine, Chicago, Illinois, United States
• Dana Farber Cancer Institute, Boston, Massachusetts, United States
• ...and 7 more locations

Frequently Asked Questions

Related Conditions

• Endometrial Cancer
• Cervical Cancer
• Ovarian Cancer
• Urothelial Carcinoma
• Biliary Tract Cancer
• Breast Cancer
• Lung Cancer
• Gastric Cancer
• Gastroesophageal-junction Cancer
• Esophageal Cancer

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