Clinical trial · Interventional
A Study of D3L-001 as Monotherapy in Subjects With HER2-Positive Advanced Solid Tumors
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER-2 Positive Advanced Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| D3L-001 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- D3L-001
- description
- Part 1 Dose Escalation in subjects with HER2-positive advanced solid tumors * Cohort 1 (starting dose) * Cohort 2 * Cohort 3 * Cohort 4 * Cohort 5 * Cohort 6 * Cohort 7 * Cohort 8 Part 2 Dose Expansion * Cohort A for subjects with HER2-positive advanced breast cancer * Cohort B for subjects with HER2-positive advanced gastric cancer/gastroesophageal junction cancer
- interventionNames
- Biological: D3L-001
Primary outcomes (2)
- measure
- Number of Participants With Adverse Events (AEs)
- timeFrame
- Screening until Safety Follow Up visit (30 days after the last dose)
- measure
- Maximum Tolerated Dose based on Dose-Limiting Toxicities (DLTs)
- timeFrame
- At the end of Cycle 1 (each cycle is 21 days).
Secondary outcomes (10)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available