HER-2 Positive Advanced Solid Tumors
Conditions
Keywords
HER-2 Positive, Advanced Solid Tumors
Brief summary
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
BIOLOGICALD3L-001
Intravenous administration
Sponsors
D3 Bio (Wuxi) Co., Ltd
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events (AEs) | Screening until Safety Follow Up visit (30 days after the last dose) |
| Maximum Tolerated Dose based on Dose-Limiting Toxicities (DLTs) | At the end of Cycle 1 (each cycle is 21 days). |
Secondary
| Measure | Time frame |
|---|---|
| D3L-001 minimum serum concentration (Ctrough) | First dose up to 6 months |
| D3L-001 maximum observed plasma concentration (Cmax) | First dose up to 6 months |
| D3L-001 time to maximum plasma concentration (tmax) | First dose up to 6 months |
| D3L-001 half-life (t1/2) | First dose up to 6 months |
| D3L-001 area under the concentration-time curve (AUC) | First dose up to 6 months |
| Incidence of anti-drug antibodies (ADA) to D3L-001 | 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) | 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) | 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 | 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) | Until disease progression or end of treatment (up to approximately 6 months) |
Countries
Australia, China, United States
Contacts
CONTACTMedical Director
Outcome results
None listed