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New treatment option for Malignant Germ Cell Tumor
Official title DBC-664 in Adult Patients With Solid Tumors Associated
ClinicalTrials.gov ID: NCT07705035
What this study is testing
What is DBC-664?
DBC-664 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for malignant germ cell tumor.
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
- DBC-664-ONC-101 is a first-in-human Phase 1a/1b open-label, multicenter study to evaluate the safety, tolerability, PK, pharmacodynamic, and preliminary anti-tumor activity of DBC-664 in patients with endometrial cancer, ovarian cancer, and other advanced solid tumors . This study is divided into 2 parts: Phase-1a Dose Escalation (Part 1), and Phase-1b Dose Expansion (Part 2).
- Phase 1: an early, usually small safety study
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
- Must be ≥18 years of age at the time consent is signed.
- Has a histologically or cytologically confirmed unresectable recurrent locally advanced or metastatic solid tumor
- Has measurable disease per RECIST v1.1 (or mRECIST 1.1 for patients with pleural mesothelioma), as assessed by the local site Investigator/radiology.
You likely can't join if
- Has a diagnosis of immunodeficiency.
- Has had a prior stem cell, bone marrow, or organ transplant.
- Has a known history of human immunodeficiency virus (HIV) infection.
- Has active or chronic hepatitis B virus (HBV), or hepatitis C virus (HCV) infection.
- Has an active autoimmune disease (non-immunotherapy induced conditions) that has required systemic treatment in the past 2 years (ie, with use of...
- Has a history of (noninfectious) pneumonitis that required steroids or current active pneumonitis/interstitial lung disease.
See the full eligibility criteria
- Must be ≥18 years of age at the time consent is signed.
- Has a histologically or cytologically confirmed unresectable recurrent locally advanced or metastatic solid tumor
- Has measurable disease per RECIST v1.1 (or mRECIST 1.1 for patients with pleural mesothelioma), as assessed by the local site Investigator/radiology.
- Has a diagnosis of immunodeficiency.
- Has had a prior stem cell, bone marrow, or organ transplant.
- Has a known history of human immunodeficiency virus (HIV) infection.
- Has active or chronic hepatitis B virus (HBV), or hepatitis C virus (HCV) infection.
- Has an active autoimmune disease (non-immunotherapy induced conditions) that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
- Has a history of (noninfectious) pneumonitis that required steroids or current active pneumonitis/interstitial lung disease.
- Has symptomatic visceral spread of disease that poses a risk of life-threatening complications in the short term, per Investigator's opinion (including massive uncontrolled effusions [pleural, pericardial, peritoneal]...
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Individuals with previously treated CNS metastases may participate provided they are radiologically stable (ie, without evidence...
- Has a history of a previous secondary malignancy within 3 years of Screening (except basal cell or squamous cell carcinoma of the skin or carcinoma in situ treated with curative therapy or other localized, low-grade...
- Has a known psychiatric or substance abuse disorder that would interfere with the individuals' ability to cooperate with the requirements of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Grand Rapids, Michigan, United States
- East Brunswick, New Jersey, United States
- Lake Success, New York, United States
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 Grand Rapids, Michigan, United States; East Brunswick, New Jersey, United States; Lake Success, New York, United States. 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.