EUCTR2019-004706-10-BE
Active, not recruiting
Phase 1
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
Conditionsocally Advanced or Metastatic Solid Tumors, and Expansion in Selected IndicationsMedDRA version: 21.1Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: HLGTClassification code 10027476Term: MetastasesSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Dragonfly Therapeutics, Inc.
- Enrollment
- 358
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Common Inclusion Criteria For All Groups/Cohorts/Combinations:
- •\- Signed written informed consent.
- •\- Male or female patients aged \= 18 years.
- •\- ECOG performance status of 0 to 1 at study entry.
- •\- Disease must be measurable with at least 1 unidimensional measurable
- •lesion by RECIST 1\.1\. (Not applicable to Accelerated Titration and 3\+3
- •Dose Escalation cohorts.
- •\- Baseline LVEF \= 55% measured by echocardiography (preferred) or
- •\- Adequate hematological function defined by white blood cell (WBC)
- •count \= 3 × 109/L with absolute neutrophil count (ANC) \= 1\.5 × 109/L,
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 factors
Investigators
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