A Study of D3L-001 as Monotherapy in Subjects With HER2-Positive Advanced Solid Tumors

NCT05957536 | Recruiting Phase 1 FDA Drug

• 1 other identifier: D3L-001-100
• Study Type: interventional
• Target: 128
• Locations: 3 countries
• Sites: 9

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.

Conditions

HER-2 Positive Advanced Solid Tumors

Keywords

HER-2 Positive; Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• 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

Study Arms (1)

D3L-001

EXPERIMENTAL

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

Biological: D3L-001

Interventions

D3L-001 BIOLOGICAL

Intravenous administration

D3L-001

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify 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 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.

Sponsors & Collaborators

• D3 Bio (Wuxi) Co., Ltd: lead

Study Sites (9)

D3 Bio Investigative Site

Stanford, California, 94305, United States

RECRUITING

D3 Bio Investigative Site

Boston, Massachusetts, 02215, United States

RECRUITING

D3 Bio Investigative Site

New York, New York, 10065, United States

RECRUITING

D3 Bio Investigative Site

San Antonio, Texas, 78229, United States

TERMINATED

D3 Bio Investigative Site

Sydney, New South Wales, 2109, Australia

RECRUITING

D3 Bio Investigative Site

Malvern, Victoria, 3144, Australia

RECRUITING

D3 Bio Investigative Site

Harbin, Heilongjiang, 150088, China

RECRUITING

D3 Bio Investigative Site

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

D3 Bio Investigative Site

Hangzhou, Zhejiang, 310022, China

RECRUITING

Central Study Contacts

Medical Director

CONTACT

+86 21 61635900; D3bio_CT@d3bio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: July 24, 2023
• Study Start: September 19, 2023
• Primary Completion (Estimated): December 19, 2028
• Study Completion (Estimated): December 19, 2028
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3); US (4); AU (2)