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New treatment option for Ovarian Neoplasms
Official title A Study of DM002 in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06751329
What this study is testing
What is DM002?
DM002 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ovarian neoplasms.
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 goal of study： The study has two parts: Part 1 Dose Escalation and Part 2 Dose Expansion. In Part 1, a few participants will receive the lowest dose of study drug.
- Phase 2: a mid-size study of how well it works
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
- Common (Part 1 and Part 2)
- people must have the ability to understand and willingness to sign a written informed consent document.
- people must be ≥18 years of age at the time of signing the informed consent form.
- people must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
- Has a life expectancy of ≥3 months.
You likely can't join if
- people have another active invasive malignancy within 5 years, with the following exceptions and notes:
- History of noninvasive malignancy, such as cervical cancer in situ, in situ melanoma, or ductal carcinoma in situ of the breast that is in complete...
- Malignancies with a negligible risk of metastasis or death (such as adequately treated basal or squamous cell skin cancer and localized prostate...
- Current or history of a hematologic malignancy.
- Anticancer therapy (chemotherapy, immunotherapy, hormonal therapy, targeted therapy, biologic therapy, or other anti-cancer therapies, except for...
- Primary central nervous system (CNS) malignancies or CNS metastases. Individuals with brain metastases can be enrolled only if treated...
See the full eligibility criteria
Who can join
- Common (Part 1 and Part 2)
- people must have the ability to understand and willingness to sign a written informed consent document.
- people must be ≥18 years of age at the time of signing the informed consent form.
- people must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
- Has a life expectancy of ≥3 months.
- Participants must meet the following laboratory values within 7 days prior to first dose of study drug: Note: Transfusion (red blood cell or platelet) or granulocyte-colony stimulating factor (G-CSF) administration is...
- Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L;
- Platelet count ≥100 × 10⁹/L;
- Hemoglobin ≥9 g/dL;
- Calculated creatinine clearance (CrCL) \>60 mL/min (Cockroft-Gault Equation);
- Total bilirubin ≤ 1.5 x ULN;
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 × upper limit of normal (ULN), if liver metastases are present, ≤5 × ULN;
- International normalized ratio (INR)\<2.0, and prothrombin time and either partial thromboplastin time (PTT) or activated PTT (aPTT) ≤1.5 × ULN, except for participants receiving anti-vitamin K derivative anticoagulant...
- Has measurable disease based on RECIST version 1.1.
- Participants are required to provide tumor tissue specimens obtained within the previous 3 years for the measurement of MUC1 and/or HER3 and other biomarkers. For those people who are unable to provide tissue samples...
What rules you out
- people have another active invasive malignancy within 5 years, with the following exceptions and notes:
- History of noninvasive malignancy, such as cervical cancer in situ, in situ melanoma, or ductal carcinoma in situ of the breast that is in complete remission 5 years after treatment with curative intent is allowed.
- Malignancies with a negligible risk of metastasis or death (such as adequately treated basal or squamous cell skin cancer and localized prostate cancer).
- Current or history of a hematologic malignancy.
- Anticancer therapy (chemotherapy, immunotherapy, hormonal therapy, targeted therapy, biologic therapy, or other anti-cancer therapies, except for hormones for hypothyroidism or estrogen replacement therapy...
- Primary central nervous system (CNS) malignancies or CNS metastases. Individuals with brain metastases can be enrolled only if treated, nonprogressive brain metastases and off high-dose steroids (\>20 mg prednisone or...
- History of known allergies to ADC, or prior discontinuation of an ADC due to treatment-related toxicities. Has received prior treatment with ADCs that include topoisomerase I (Topo I) payload, and treatment history with...
- Has an uncontrolled infection requiring IV injection of antibiotics, antivirals, or antifungals.
- Has a pre-existing clinically significant lung diseases (e.g., interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or pre-existing ocular disorders.
- Clinically uncontrolled intercurrent illness, including but not limited to an ongoing active infection, active coagulopathy, uncontrolled cardiovascular disease, uncontrolled immune disease, uncontrolled diabetes...
- Mean resting corrected QT interval corrected by Fridericia's formula (QTcF) \>470 msec obtained from triplicate 12-lead ECGs at baseline; using concomitant medications that would prolong the QT interval.
- Left ventricular ejection fraction \<50% by either an echocardiogram (ECHO) or a multi-gated acquisition scan within 28 days before first dose of the study drug.
- Known active hepatitis B (HBV) or hepatitis C (HCV) infection. Chronic carriers of HBV infection (HBsAg-positive, undetectable HBV DNA or HBV DNA ≤2500 copies/ml or 500 IU/ml) receive prophylactic treatment during the...
- Known human immunodeficiency virus (HIV) infection which is not well controlled. Participants should be tested for HIV prior to enrollment if required by local regulations or institutional review board (IRB)/ethics...
- people who are from endemic areas (refer to WHO high tuberculosis burden country list, China is endemic area) will be specifically screened for tuberculosis with any available test. people with active tuberculosis are...
- Has received a live vaccine within 30 days prior to the first dose of study drug.
- Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia and anemia) not yet resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)...
- Females who are pregnant or lactating or who intend to become pregnant during participation in the study are not eligible to participate.
- Participants who are of reproductive potential refuse to use effective methods of birth control during participation of the study and within 7 months for female (and 4 months for male) after the last dose administration.
- Participants who took drugs or food which can strongly inhibit or induce the cytochrome P450 (CYP) isoenzyme, CYP3A4/5 within 2 weeks prior to the first dose of DM002 or within 5 half-lives, whichever is longer.
The study team makes the final eligibility decision.
Where it's taking place
- Oklahoma City, Oklahoma, United States
- Houston, Texas, United States
- Randwick, New South Wales, Australia
- Wollongong, New South Wales, Australia
- Adelaide, South Australia, Australia
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 Oklahoma City, Oklahoma, United States; Houston, Texas, United States; Randwick, New South Wales, Australia; Wollongong, New South Wales, Australia; Adelaide, South Australia, Australia. 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.