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Clinical Trials/NL-OMON52911
NL-OMON52911RecruitingNot Applicable

A Phase I/II, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF1001 in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications - DF1001-001

Dragonfly Therapeutics, Inc.0 sites25 target enrollmentStarted: TBDLast updated:
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Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
25
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 to 99 (—)

Inclusion Criteria

  • •General Inclusion criteria for all study parts:
  • •This study will enroll patients aged >=18 years who have provided written
  • •informed consent and have adequate hematologic, liver, renal and
  • •cardiac function and performance status.
  • •For all Safety/PK/PD Cohorts, monotherapy and combination therapy,
  • •paired biopsies (screening and on study) are mandatory for
  • •participation.
  • •Monotherapy Dose Escalation
  • •Histologically or cytologically proven locally advanced or metastatic solid
  • •tumors, for which no standard therapy exists, or standard therapy has
  • •failed. HER2 expression by immunohistochemistry and/or erbb2
  • •amplification and/or erbb2 activating mutations must be documented on
  • •either archival tissue or fresh tumor biopsy.
  • •Nivolumab Dose Escalation
  • •Patients must be eligible to receive nivolumab per its label for a
  • •malignancy of epithelial origin.
  • •Patients for which no standard therapy exists or standard therapy has
  • •Nab paclitaxel Dose Escalation
  • •Be eligible for treatment with nab-paclitaxel per its label, which includes
  • •metastatic breast cancer, after failure of combination chemotherapy for
  • •metastatic disease or relapse within 6 months of adjuvant
  • •chemotherapy. In this case, additional inclusion criteria also includes no
  • •exposure to taxanes in the last 6 months.
  • •Have a tumor that has no standard therapy or for which standard
  • •therapy has failed. In this case, patients should also not have been
  • •treated with a taxane over the last 6 months.
  • •First line advanced (unresectable/recurrent/metastatic) TNBC.
  • •Phase 2 Efficacy Expansion Cohorts Patients must have one of the
  • •following tumor types: Non-small cell lung cancer (NSCLC, HER2 low or erbb2
  • •amplified),
  • •Urothelial bladder cancer (UBC), Breast Cancer (HER2 high or HER2 low),
  • •Gastric cancer (HER2 high or HER2 low), Adenocarcinoma of the esophagus (HER2
  • •high or HER2 low)
  • •or a solid tumor with overexpressing of rb-B2 Receptor Tyrosine Kinase 2 (erbb2
  • •amplified).
  • •Patients must meet all inclusion criteria specific to their tumor type, as
  • •outlined in section 5.2.

Exclusion Criteria

  • •Exclusion Criteria for All Patients of Both Study Parts:
  • •1. Previous treatment with drugs that specifically target the HER2 pathway (mAb
  • •or tyrosine kinase inhibitor [TKI]) is acceptable providing washout period
  • •2. Concurrent anticancer treatment, immune therapy, or cytokine therapy
  • •3. Life expectancy of less than 3 months.
  • •4. Active or history of central nervous system (CNS) metastases.
  • •5. Receipt of any organ transplantation including autologous or allogeneic
  • •stem-cell transplantation.
  • •6. Significant acute or chronic infections
  • •7. Preexisting autoimmune disease needing treatment with systemic
  • •immunosuppressive agents >= 28 days within the last 3 years or clinically
  • •relevant immunodeficiencies (e.g, dys-gammaglobulinemia or congenital
  • •immunodeficiencies), or fever Grade 2 or higher within 7 days of Day
  • •1.Patients with a history of autoimmune-related hypothyroidism on a
  • •stable dose of thyroid replacement hormone may be eligible for this
  • •study. Patients with controlled Type 1 diabetes mellitus on a stable
  • •insulin regimen may be eligible for this study.
  • •8. Pregnancy or lactation in females during the study.
  • •9. Serious cardiac illness or clinically relevant uncontrolled cardiac risk

Investigators

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