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New treatment option for HER-2 Positive Advanced Solid Tumors
Official title A Study of D3L-001 as Monotherapy in Subjects With HER2-Positive Advanced Solid Tumors
ClinicalTrials.gov ID: NCT05957536
What this study is testing
What is D3L-001?
D3L-001 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for her-2 positive advanced solid tumors.
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
- This first-in-human (FIH) study, multi-center, open-label, dose escalation and dose expansion Phase I study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary anti-tumor activity of D3L-001 in subjects with HER2-positive advanced solid tumors.
- 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
- Subject must have documented HER2 positivity (determined by immunohistochemistry [IHC], in situ hybridization [ISH], Next Generation Sequencing [NGS]...
- Subject must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Subject must have left ventricular ejection fraction (LVEF) ≥50% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA) within the...
- Subject must have adequate organ and marrow function within the screening period.
You likely can't join if
- Subject has any prior treatment with anti-CD47 or SIRPα agent.
- Subject has any prior treatment without adequate washout periods as defined in the protocol.
- Subject has immunosuppressive medication that is not completed 14 days before the first dose of study medication.
- Subject has uncontrolled intercurrent illness that would limit compliance with study requirements, substantially increase risk of incurring AEs, or...
- Subject has unresolved treatment-related toxicities from previous anticancer therapy of NCI CTCAE Grade ≥2 (with exception of vitiligo or alopecia).
- Judgment by the Investigator that the subject should not participate in the study if the subject is unlikely to comply with study procedures...
The study team makes the final eligibility decision.
Where it's taking place
- Stanford, California, United States
- Boston, Massachusetts, United States
- New York, New York, United States
- San Antonio, Texas, United States
- Sydney, New South Wales, Australia
- Malvern, Victoria, Australia
- Harbin, Heilongjiang, China
- Shanghai, Shanghai Municipality, China
- Hangzhou, Zhejiang, China
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 Stanford, California, United States; Boston, Massachusetts, United States; New York, New York, United States; San Antonio, Texas, United States; Sydney, New South Wales, Australia; Malvern, Victoria, Australia and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.