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
- Conditions
- Locally Advanced or Metasatic Metastatic Tumor / Locally Advanced or Metastatic Cancer10027476
- Registration Number
- NL-OMON52911
- Lead Sponsor
- Dragonfly Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 25
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.
OR
Patients for which no standard therapy exists or standard therapy has
failed.
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.
OR
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.
OR
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 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method