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Endometrial CancerPhase 1NCT06293898

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

A Phase 1 study testing BL-M07D1 in people with Endometrial Cancer and Cervical Cancer, run by SystImmune Inc. at 26 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
BL-M07D1
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
280 participants
Where
26 sitesUnited States
Study dates
9 Feb 2024to 15 Apr 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must meet all the following inclusion criteria 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 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:
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  • 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 mandated, at the discretion of the investigator.
  • 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 (see details in Section 7.1.1).
  • 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 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 ≤2
  • 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 colony-stimulating factor (G-CSF) use are not allowed 1 week prior to screening]
  • 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 (ALT) without liver metastasis ≤3.0×ULN, AST and ALT with liver metastasis ≤5.0×ULN
  • 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 Collaboration [CKD-EPI] equation)
  • 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 intended therapeutic range
  • 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 study treatment (7 months for women of childbearing potential and 4 months for men). An additional contraceptive method, such as a barrier method (eg, condom), is recommended.
  • 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 permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman >45 years old in the absence of other biological or physiological causes). In addition, females <55 years old must have a serum follicle stimulating hormone (FSH) level >40 mIU/mL to confirm menopause. NOTE: Documentation may include review of medical records, medical examination, or medical history interview by study site staff. Additional Inclusion Criteria for Dose Expansion
  • For participants with urothelial carcinoma (Part A: Randomized 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 histological types are allowed if urothelial is the primary histology; however, small cell histology is excluded.
  • 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 advanced or metastatic setting. Patients treated with enfortumab/pembrolizumab in the localized muscle invasive setting will be eligible. Prior platinum therapy is allowed but not required.
  • Participants should have no more than 3 prior lines of systemic cytotoxic therapy (eg, ADC, chemotherapy) in the advanced or metastatic setting.
  • 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 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:
  • 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).

Who cannot join

  • 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 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
  • 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 myocardial infarction or unstable angina pectoris within 6 months before enrollment.
  • 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 skin diseases that do not require systemic treatment (such as vitiligo, psoriasis), well-controlled type 1 diabetes, or hypothyroidism are permitted. For autoimmune conditions that are active but stable and low grade on systemic therapy, discussion with the medical monitor is required prior to screening
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  • 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 intent with a disease-free interval of at least 3 years prior to screening
  • 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 by imaging at screening
  • 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 therapy for at least 3 weeks before enrollment
  • 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 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 (<10 mg prednisone or equivalent/day) may participate
  • 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, 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
  • 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 reaction is negative for HCV RNA
  • 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 stable oral antimicrobials with no clinical or laboratory evidence of active infection are eligible
  • 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

Trial locations and contacts

26 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Roy Daneker contact

425-453-6841

roy.daneker@systimmune.com

Hamza Abidi contact

425-453-6841

hamza.abidi@systimmune.com

26 sites in 1 country

United States26 sites, 24 recruiting

  • Georgia Cancer Center at Augusta University

    Augusta, Georgia, 30912

    Gwendolyn Stanley, 706-721-3473, gstanley@augusta.edu

    Marian S Johnson, MD

    Recruiting

  • University of Alabama Birmingham

    Birmingham, Alabama, 35294

    Desi Campbell, 205-644-2574, desidcampbell@uabmc.edu

    Ibrahim Muhsen, MD

    Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

    Joyce Liu, MD, MPH, 857-338-7425, Joyce_Liu@dfci.harvard.edu

    Joyce Liu, MD, MPH

    Recruiting

  • University of Illinois Cancer Center

    Chicago, Illinois, 60612

    Omer Qazi, 312-413-1069, omerqazi@uic.edu

    Oana Danciu, MD

    Recruiting

  • University of Chicago Medicine

    Chicago, Illinois, 60637

    Alex Morales, 773-702-3320, Alex.Morales@bsd.uchicago.edu

    Gini Fleming, MD

    Recruiting

  • Karmanos Cancer Institiute

    Detroit, Michigan, 48201

    Davonna Felder, 313-576-9014, FelderD@karmanos.org

    Wasif Saif, MD

    Recruiting

  • City of Hope

    Duarte, California, 91010

    Erin Morones, 626-218-9708, emorones@coh.org

    Abhishek Tripathi, MD

    Recruiting

  • START - New Jersey

    East Brunswick, New Jersey, 08816

    Julie Burns, julie.burns@startresearch.com

    Bruno Fang

    Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

    Janice Alcaide, 703-208-3771, janice.alcaide@usoncology.com

    Alexander Spira, MD

    Recruiting

  • Start - Dfw

    Fort Worth, Texas, 76014

    Karen McGee

    Henry Xiong

    Recruiting

  • Oncology Consultants

    Houston, Texas, 77030

    Laura Guerra, 713-600-0913

    Julio Peguero, MD

    Recruiting

  • Start (Nyli)

    Lake Success, New York, 11040

    Geraldine O'Sullivan Coyne

    Recruiting

  • START - Los Angeles

    Los Angeles, California, 90025

    Maribeth De Perio, maribeth.deperio@startresearch.com

    Navid Hafez

    Recruiting

  • UCLA Department of Medicine - Hematology/Oncology

    Los Angeles, California, 90095

    Active, not recruiting

  • Cedars Sinai

    Los Angeles, California, 90211

    GroupCancerTrialINformation@cshs.org

    Jin Sun Bitar, MD

    Recruiting

  • University of Miami

    Miami, Florida, 33136

    Milton Ortega, mdo37@med.miami.edu

    Gilberto Lopes, MD

    Recruiting

  • NYU Langone Hospital - Long Island Investigational Pharmacy

    Mineola, New York, 11501

    Amy Ciriaco, 516-663-4895, Amy.Ciriaco@nyulangone.org

    Nancy Chan, MD

    Recruiting

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

    Scott Miller, 615-856-0995, Scott.Miller@scri.com

    Erika Hamilton, MD

    Recruiting

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

    New York, New York, 10016

    Catia Neves, 646-754-4403, Catia.Neves@nyulangone.org

    Nancy Chan, MD

    Recruiting

  • Sarah Cannon Research Institute - Lake Nona Florida

    Orlando, Florida, 32827

    Heather Taylor, 904-380-2410, Heather.Taylor@scri.com

    Cesar Perez Batista, MD

    Recruiting

  • Providence Portland Medical Center

    Portland, Oregon, 97213

    Lindsay Anderson, lindsay.d.anderson@providence.org

    Rachel Sanborn, MD

    Recruiting

  • Providence Cancer Institute (Westside)

    Portland, Oregon, 97225

    Rachel Sanborn, MD

    Recruiting

  • START - San Antonio

    San Antonio, Texas, 78229

    Karen McGee, karen.mcgee@startresearch.com

    Drew Rasco

    Recruiting

  • Scripps Health

    San Diego, California, 92121

    Jackie Dexter, Dexter.Jackie@scrippshealth.org

    Wesleigh Edwards, MD

    Recruiting

  • WashU - Siteman Cancer Center

    St Louis, Missouri, 63110

    Active, not recruiting

  • City of Hope - Chicago

    Zion, Illinois, 60099

    Sylvia Riehl, 847-746-6983, sriehl@coh.org

    Kevin Zhang

    Recruiting

Other trials in United States

About this study

Official title: 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

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

Read the detailed description

BL-M07D1-ST-101 is a global, multi-center, Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BL-M07D1 in participants with HER2 expressing advanced malignant solid tumors.

This study will be conducted in three parts (dose escalation, dose finding and dose expansion). Dosing will be conducted on Day 1 of a continuous 21-day treatment cycle. .

Being tested
BL-M07D1
Keywords
HER2
Medical subject headings
Endometrial Neoplasms, Uterine Cervical Neoplasms, Ovarian Neoplasms, Carcinoma, Transitional Cell, Biliary Tract Neoplasms, Breast Neoplasms, Lung Neoplasms, Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BL-M07D1Drug

    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-M07D1 will be administered on Day 1 by intravenous infusion every 3 weeks.

    Other Names:

    BL-M07D1

Study groups in NCT06293898
Study groupRoleWhat they receive
Experimental: Dose EscalationExperimentalBeginning with Cycle 1, BL-M07D1 will be administered on Day 1 by (IV) infusion every 3 weeks (D1Q3W)
Receives: Drug: BL-M07D1
Experimental: Dose FindingExperimentalBeginning with Cycle 1, BL-M07D1 will be administered on Day 1 by (IV) infusion every 3 weeks (D1Q3W)
Receives: Drug: BL-M07D1
Experimental: Dose ExpansionExperimentalBeginning with Cycle 1, BL-M07D1 will be administered on Day 1 by (IV) infusion every 3 weeks (D1Q3W)
Receives: Drug: BL-M07D1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Summary of safety

    The number of patients with dose-limiting toxicities, serious adverse events, treatment-emergent adverse events, physical exam findings, vital signs, laboratory tests, ECG parameters and echocardiograph

    Measured: Though study completion, an average of 24 months

  2. 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

    Determine the highest BL-M07D1 dose level at which subjects do not experience a DLT during the DLT evaluation period and highest BL-M07D1 dose administered in the event and MTD cannot be defined.

    Measured: 21 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2024
  2. Study start9 Feb 2024
  3. Primary completion15 Dec 2028 (estimated)
  4. Study completion15 Apr 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
280 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06293898
Sponsor's protocol ID
BL-M07D1-ST-101
Status last verified
Oct 2026
First submitted
22 Feb 2024
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BL-M07D1 in people with Endometrial Cancer and Cervical Cancer, run by SystImmune Inc. at 26 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 46 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Roy Daneker (425-453-6841, roy.daneker@systimmune.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Summary of safety (time frame: Though study completion, an average of 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06293898.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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