RecruitingPhase 1

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

United States280 participantsStarted 2024-02-09

Plain-language 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

Age range18 Years

SexALL

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Inclusion criteria

✓. Age: ≥18 years
✓. Has a life expectancy of ≥3 months
✓. 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:
✓. Cohort 1: Subjects with HER2 expression in endometrial cancers (EC)
✓. Cohort 2: Subjects with HER2 expression in cervical cancers (CC)
✓. Cohort 3: Subjects with HER2 expression in ovarian cancers (OC) including fallopian tube cancer and primary peritoneal cancer
✓. Cohort 4: Subjects with HER2 expression in urothelial cancers (UC)
✓. Cohort 5: Subjects with HER2 expression in biliary tract cancers (BTC)

Exclusion criteria

✕. 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
✕. Subjects with history of severe heart disease
✕. Subjects with prolonged QT interval (QTc \>470 msec), complete left bundle branch block, Grade 3 atrioventricular block
✕. Active autoimmune diseases and inflammatory diseases
✕. Other malignant tumors diagnosed within 3 years prior to the first administration considered to be in remission
✕. Subjects with poorly controlled hypertension by 2 types of antihypertensive drugs (systolic blood pressure \>150 mmHg or diastolic blood pressure \>100 mmHg)
✕. Subjects with advanced or clinically significant lung diseases, such as poorly controlled chronic obstructive pulmonary disease and asthma, restrictive lung disease, pulmonary hypertension, etc.
✕. Subjects with stroke, transient ischemic attack within 6 months before enrollment

What they're measuring

Summary of safety

Timeframe: 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

Timeframe: 21 Days

Trial details

NCT IDNCT06293898

SponsorSystImmune Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-12-15

Contact for this trial

Christine LaRock

425-453-6841 christine.larock@systimmune.com

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