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Study of DF1001 in Patients With Advanced Solid Tumors

NCT04143711 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2026-03-18

No results posted yet for this study

Summary

DF1001-001 is a study of a new molecule that targets natural killer (NK) cells and T-cell activation signals to specific receptors on cancer cells. The study will occur in two phases. The first phase will be a dose escalation phase, enrolling patients with various types of solid tumors that express human epidermal growth factor receptor 2 (HER2). The second phase will include a dose expansion using the best dose selected from the first phase of the study. Multiple cohorts will be opened with eligible patients having either HER2 activated non-small cell lung cancer, hormone receptor (HR) positive HER2 negative metastatic breast cancer, or HER2 positive metastatic breast cancer. DF1001-001 will be administered as monotherapy or in combination; combinations are DF1001 + nivolumab, DF1001 + Nab paclitaxel, and DF1001 + sacituzumab govitecan-hziy.

Conditions

  • Solid Tumor, Adult

Interventions

DRUG

DF1001

Immunotherapy agent targeting NK cells.

DRUG

Nivolumab

Anti-PD-1 immunotherapy agent

DRUG

Nab paclitaxel

A chemotherapy treatment combining paclitaxel with albumin

DRUG

Sacituzumab Govitecan-hziy

A Trop-2 (Tumor-associated calcium signal transducer 2) directed antibody and topoisomerase inhibitor drug conjugate

Sponsors & Collaborators

  • Dragonfly Therapeutics

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-11
Primary Completion
2025-12-05
Completion
2025-12-05
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Denmark
  • France
  • Netherlands
  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04143711 on ClinicalTrials.gov