Study of DF1001 in Patients With Advanced Solid Tumors

Part of paid clinical trials in Irvine, California.

Sponsor
Dragonfly Therapeutics
Study ID
NCT04143711
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Solid Tumor, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DF1001 — DRUG
    Immunotherapy agent targeting NK cells.
  • Nivolumab — DRUG
    Anti-PD-1 immunotherapy agent
  • Nab paclitaxel — DRUG
    A chemotherapy treatment combining paclitaxel with albumin
  • Sacituzumab Govitecan-hziy — DRUG
    A Trop-2 (Tumor-associated calcium signal transducer 2) directed antibody and topoisomerase inhibitor drug conjugate

Study Details

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.

Key Dates

Start date
Nov 11, 2019
Status verified
Mar 2026
Primary completion
Dec 5, 2025
Completion
Dec 5, 2025

Study Design

Enrollment
270 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Monotherapy DF1001 Dose Escalation
    Dose escalation cohorts of DF1001 in sequential ascending order.
  • Experimental: Monotherapy DF1001 Safety/PK/PD Expansion
    Expansion cohorts of monotherapy DF1001 in multiple dose levels after evaluation for safety in Monotherapy Dose Escalation arm. Additional pharmacokinetic (PK) and pharmacodynamic (PD) samples included in this arm.
  • Experimental: Monotherapy DF1001 Expansion in Urothelial Bladder Cancer
    Monotherapy expansion cohort enrolling up to 20 patients with urothelial bladder cancer using the recommended phase 2 dose (RP2D) identified in the Monotherapy Dose Escalation arm.
  • Experimental: Monotherapy DF1001 Expansion in Metastatic Breast Cancer (HER2 Low)
    Monotherapy expansion cohort enrolling up to 20 patients with metastatic breast cancer with documented low expression of HER2 using the recommended phase 2 dose (RP2D) identified in the Monotherapy Dose Escalation arm.
  • Experimental: Monotherapy DF1001 Expansion in Cancers with Erbb2 Amplification
    Monotherapy expansion cohort enrolling up to 40 patients with solid tumors showing documented erbb2 amplification using the recommended phase 2 dose (RP2D) identified in the Monotherapy Dose Escalation arm.
  • Experimental: Combination Therapy with DF1001 and Nivolumab
    Combination dose escalation of DF1001 in combination with nivolumab in patients with select solid tumors.
  • Experimental: Combination Therapy with DF1001 and Nab-paclitaxel
    Combination dose escalation of DF1001 in combination with nab-paclitaxel in patients with select solid tumors.
  • Experimental: Combination Therapy with DF1001 and Nivolumab Safety/PK/PD Expansion
    Expansion cohort of DF1001 in combination with nivolumab after evaluation for safety in the Combination Therapy with DF1001 and nivolumab Dose Escalation arm. Additional pharmacokinetic (PK) and pharmacodynamic (PD) samples included in this arm.
  • Experimental: Combination Therapy with DF1001 and Nab-paclitaxel Safety/PK/PD Expansion
    Expansion cohort of DF1001 in combination with nab-paclitaxel after evaluation for safety in the Combination Therapy with DF1001 and nab-paclitaxel Dose Escalation arm. Additional pharmacokinetic (PK) and pharmacodynamic (PD) samples included in this arm.
  • Experimental: Combination Therapy with DF1001 and Nivolumab Expansion in Urothelial Bladder Cancer
    Combination therapy with DF1001 and nivolumab expansion cohort enrolling up to 20 patients with urothelial bladder cancer using the recommended phase 2 dose (RP2D) identified in the Combination Therapy with DF1001 and nivolumab arm.
  • Experimental: Monotherapy DF1001 Expansion in Metastatic Breast Cancer (HER2 High)
    Monotherapy expansion cohort enrolling up to 20 patients with metastatic breast cancer with documented high expression of HER2 using the recommended phase 2 dose (RP2D) identified in the Monotherapy Dose Escalation arm.
  • Experimental: Monotherapy DF1001 Expansion in NSCLC
    Monotherapy expansion cohort enrolling up to 20 patients with non-small cell lung cancer with documented erbb2 amplification using the recommended phase 2 dose (RP2D) identified in the Monotherapy Dose Escalation arm.
  • Experimental: Combination Therapy with DF1001 and Nivolumab Expansion in NSCLC
    Combination therapy with DF1001 and nivolumab expansion cohort enrolling up to 20 patients with non-small cell lung cancer with documented low expression of HER2 using the recommended phase 2 dose (RP2D) identified in the Combination Therapy with DF1001 and nivolumab arm.
  • Experimental: Monotherapy DF1001 Expansion in Gastric Cancer
    Monotherapy expansion cohort enrolling up to 20 patients with gastric cancer with documented high expression of HER2 using the recommended phase 2 dose (RP2D) identified in the Monotherapy Dose Escalation arm.
  • Experimental: Combination Therapy with DF1001 and Nivolumab Expansion in Gastric Cancer
    Combination therapy with DF1001 and nivolumab expansion cohort enrolling up to 20 patients with gastric cancer with documented low expression of HER2 using the recommended phase 2 dose (RP2D) identified in the Combination Therapy with DF1001 and nivolumab arm.
  • Experimental: Monotherapy DF1001 Expansion in Esophageal Cancer
    Monotherapy expansion cohort enrolling up to 20 patients with esophageal cancer with documented high expression of HER2 using the recommended phase 2 dose (RP2D) identified in the Monotherapy Dose Escalation arm.
  • Experimental: Combination Therapy with DF1001 and Nivolumab Expansion in Esophageal Cancer
    Combination therapy with DF1001 and nivolumab expansion cohort enrolling up to 20 patients with esophageal cancer with documented low expression of HER2 using the recommended phase 2 dose (RP2D) identified in the Combination Therapy with DF1001 and nivolumab arm.
  • Experimental: Monotherapy DF1001 Exploratory Efficacy Expansion in NSCLC
    Monotherapy expansion cohort enrolling up to 20 patients with non-small cell lung cancer with documentation of HER2 activation.
  • Experimental: Combo Therapy with DF1001 and Sacituzumab Govitecan-hziy Exploratory Efficacy Expansion in NSCLC
    Combination therapy with DF1001 and sacituzumab govitecan-hziy cohort enrolling up to 20 patients, including safety lead-in, with non-small cell lung cancer with documentation of HER2 activation.
  • Experimental: Monotherapy DF1001 Exploratory Efficacy Expansion in Metastatic Breast Cancer (HR+/HER2-)
    Monotherapy expansion cohort enrolling up to 20 patients with metastatic breast cancer with documentation of HR positive and HER2 negative expression.
  • Experimental: DF1001 with Sacituzumab Govitecan-hziy Exploratory Efficacy Expansion in Breast Cancer (HER2+)
    Combination therapy with DF1001 and sacituzumab govitecan-hziy cohort enrolling up to 40 patients, including safety lead-in, with metastatic breast cancer with documentation of HER2 positive expression.
  • Experimental: DF1001 with Sacituzumab Govitecan-hziy Exploratory Efficacy Expansion in Breast Cancer (HR+/HER2-)
    Combination therapy with DF1001 and sacituzumab govitecan-hziy cohort enrolling up to 40 patients, including safety lead-in, with metastatic breast cancer with documentation of HR positive and HER2 negative expression.

Primary Outcome Measure

Assessment of number of dose limiting toxicities experienced on study as defined per criteria in the study protocol [ Time Frame: First 3 weeks of treatment for each subject. ]

Locations (16)

FacilityCityStateZIPSite coordinators
University of California Irvine Medical CenterIrvineCalifornia92868-
University of Southern CaliforniaLos AngelesCalifornia90033-
Sharp HealthcareSan DiegoCalifornia92123-
University of California San FranciscoSan FranciscoCalifornia94143-
University of Kansas Medical Center Research Institute, Inc.WestwoodKansas66205-
Louisiana State UniversityNew OrleansLouisiana70112-
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimoreMaryland21287-
Icahn School of Medicine: Tisch Cancer Institute at Mount Sinai Medical CenterNew YorkNew York10023-
Montefiore Einstein Center for Cancer CareThe BronxNew York10461-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
The Ohio State UniversityColumbusOhio43210-
Rhode Island HospitalProvidenceRhode Island02903-
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-
MD Anderson Cancer CenterHoustonTexas77030-
Multicare Health System Tacoma General HospitalTacomaWashington98405-
University of WisconsinMadisonWisconsin53715-

Find similar trials in Irvine, CA

By research site
University of California Irvine Medical Center· Irvine, CAUniversity of Southern California· Los Angeles, CASharp Healthcare· San Diego, CAUniversity of California San Francisco· San Francisco, CAUniversity of Kansas Medical Center Research Institute, Inc.· Westwood, KSLouisiana State University· New Orleans, LA

Related Studies