PhI/II FirstInHuman Study DF9001 Comb w/Nivolumab Pa w/Solid Tumors Selected Indications

Official Title

A Phase I/II, First-In-Human, Multi-Part, Open-Label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of DF9001 as a Monotherapy and in Combination with Nivolumab in Patients With Advanced (Unresectable, Recurrent, or Metastatic) Solid Tumors, and Expansion in Selected Indications

Details

DF9001-001 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 epidermal growth factor receptor (EGFR). A combination therapy cohort will be opened for enrollment, DF9001 + nivolumab. 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 selected solid tumors.

You can join if...

Inclusion Criteria:

1. You must sign a written informed consent.
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at study entry and an estimated life expectancy of at least 3 months.
3. You must have adequate hematological function.
4. You must have adequate hepatic function.
5. You must have adequate renal function.
6. You must use effective contraception for women of child bearing potential (WOCBP) patients as defined by World Health Organization (WHO) guidelines for 1 "highly effective" method or 2 "effective" methods.

Exclusion Criteria:

1. You must not have had chemotherapy, radiotherapy (other than palliative bone-directed radiotherapy), or major surgery, or received another investigational agent within 28 days or 5-half-lives of the drug (if known), whichever is shorter, before the start of study treatment.
2. You must not have concurrent anticancer treatment (eg, cytoreductive therapy, radiotherapy [except for palliative bone-directed radiotherapy], immune therapy, or cytokine therapy [except for erythropoietin]), major surgery (excluding prior diagnostic biopsy), concurrent systemic therapy with steroids or other immunosuppressive agents, or use of any investigational drug within 28 days or 5-half-lives of the drug (if known), whichever is shorter, before the start of study treatment. Short-term administration of systemic steroids (eg, for allergic reactions or the management of irAEs) is allowed.
3. Life expectancy of less than 3 months.