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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors

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

Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors (NCT06293898) is a Phase 1 interventional studying Endometrial Cancer and Cervical Cancer, sponsored by SystImmune Inc.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Endometrial Cancer, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 280 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Endometrial Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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 antibodies or any of the components of BL M07D1 11\. Subjects 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, treatment with low dose glucocorticoids (≤10 mg/day equivalent of prednisone) is permitted. The chronic use of topical, inhaled, and locally injected steroids is permitted 12. Subjects who have received treatment with anthracyclines with a cumulative dose exceeding 360 mg/m2 13.Subjects with known human immunodeficiency virus (HIV) infection (HIV antibody positive). Subjects are allowed to participate if all the following criteria are met: 1. Undetectable HIV RNA and CD4 count ≥ 350 cells/μL at screening; 2. No AIDS-defining opportunistic infection within 12 months prior to screening; 3. 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. 14\. Subjects with known active hepatitis C virus (HCV) infection (HCV antibody positive and HCV-RNA \> the lower limit of detection). Subjects with a positive anti-HCV antibody are eligible only if PCR is negative for HCV RNA 15. Subjects with known active tuberculosis 16 .Subjects 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. Subjects on stable oral antimicrobials with no clinical or laboratory evidence of active infection are eligible. 17\. Subjects who are pregnant or, breastfeeding, or planning to become pregnant during the study 18. Other conditions that the investigator or sponsor believes are not suitable for participating in this clinical trial. 16\. Other conditions that the investigator believes are not suitable for participating in this clinical trial.

Treatments Being Tested

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

Locations (17)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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
Karmanos Cancer Institiute
Detroit, Michigan, United States
NYU Langone Hospital - Long Island Investigational Pharmacy
Mineola, New York, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States
Providence Portland Medical Center
Portland, Oregon, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Oncology Consultants
Houston, Texas, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06293898), the sponsor (SystImmune Inc.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06293898 clinical trial studying?

The objective of this study is to evaluate the safety, tolerability, and efficacy of BL-M07D1 in patients with HER2 expressing advanced tumors. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06293898?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06293898?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06293898. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06293898. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.