Recruiting NCT05957536
A Study of D3L-001 as Monotherapy in Subjects With HER2-Positive Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: D3L-001.
- Who it may be relevant to
- Registry conditions: HER-2 Positive Advanced Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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.
Overview
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.
Interventions
- Biological D3L-001
Intravenous administration
Primary outcome measures
- Number of Participants With Adverse Events (AEs) [Time frame: Screening until Safety Follow Up visit (30 days after the last dose)]
- Maximum Tolerated Dose based on Dose-Limiting Toxicities (DLTs) [Time frame: At the end of Cycle 1 (each cycle is 21 days).]
Secondary outcome measures (10)
- D3L-001 minimum serum concentration (Ctrough) [Time frame: First dose up to 6 months]
- D3L-001 maximum observed plasma concentration (Cmax) [Time frame: First dose up to 6 months]
- D3L-001 time to maximum plasma concentration (tmax) [Time frame: First dose up to 6 months]
- D3L-001 half-life (t1/2) [Time frame: First dose up to 6 months]
- D3L-001 area under the concentration-time curve (AUC) [Time frame: First dose up to 6 months]
- Incidence of anti-drug antibodies (ADA) to D3L-001 [Time frame: First dose up to 6 months]
- Objective response rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) [Time frame: Until disease progression or end of treatment (up to approximately 6 months)]
- Duration of Response (DOR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) [Time frame: Until disease progression or end of treatment (up to approximately 6 months)]
- Disease control rate (DCR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 [Time frame: Until disease progression or end of treatment (up to approximately 6 months)]
- Progression-free survival (PFS) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) [Time frame: Until disease progression or end of treatment (up to approximately 6 months)]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 4 centers
- D3 Bio Investigative Site — Stanford
- D3 Bio Investigative Site — Boston
- D3 Bio Investigative Site — New York
- D3 Bio Investigative Site — San Antonio
China · 3 centers
- D3 Bio Investigative Site — Harbin
- D3 Bio Investigative Site — Shanghai
- D3 Bio Investigative Site — Hangzhou
Australia · 2 centers
- D3 Bio Investigative Site — Sydney
- D3 Bio Investigative Site — Malvern
Identifiers
NCT: NCT05957536 · D3L-001-100