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

Conditions

• HER-2 Positive Advanced Solid Tumors

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• D3L-001 — BIOLOGICAL
  Intravenous administration

Study Details

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.

Key Dates

Start date

Sep 19, 2023

Status verified

Mar 2026

Primary completion

Dec 19, 2028

Completion

Dec 19, 2028

Study Design

Enrollment

128 participants (estimated)

Allocation

NA

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: D3L-001
  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

Primary Outcome Measure

Number of Participants With Adverse Events (AEs) [ Time Frame: Screening until Safety Follow Up visit (30 days after the last dose) ]

Central Contacts

• Medical Director
  +86 21 61635900
  [email protected]

Locations (4)

Find similar trials in Stanford, CA