Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
Clinical summary
Summary
This Phase 1, open-label, multi-site study will run in two stages: dose escalation and dose expansion.
Part 1 (dose escalation) is planned for up to 5 cohort levels, with Cohort 1 being the starting dose. People with people with HER2-positive advanced solid cancers will be eligible for Part 1.
Part 2 (dose expansion) consists of two cohorts: Cohort A for participants with HER2-positive advanced breast cancer and
Cohort B for participants with HER2-positive advanced gastric cancer/gastroesophageal junction cancer.
The drug D3L-001 will be administered intravenously to approximately 110 study participants.
Conditions
This trial is treating people with HER2-positive advanced cancers
Eligibility
Inclusion
- Subject must have documented HER2 positivity (determined by immunohistochemistry [IHC], in situ hybridization [ISH], Next Generation Sequencing [NGS] or other analysis techniques as appropriate).
- 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 screening period.
- Subject must have adequate organ and marrow function within the screening period.
Exclusion
- Subject has any prior treatment with anti-CD47 or SIRPα agent.
- Subject has major surgery or radiotherapy, immunostimulatory agents, investigational agents, or any other anticancer treatment including chemotherapy, targeted therapy, biologics that is not completed 28 days before first dose of study medication.
- 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 compromise the ability of the subject to give written informed consent.
- 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, restrictions, and requirements.
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body (localised).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
D3 Bio (Wuxi) Co., Ltd
Scientific Title
A Phase 1, Open-label Dose Escalation and Dose-Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3L-001 Monotherapy in Subjects With HER2-Positive Advanced Solid Tumors.
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