DFF332 as a Single Agent and in Combination With Everolimus & Immuno-Oncology Agents in Advanced/… (NCT04895748) | Clinical Trial Compass
TerminatedPhase 1
DFF332 as a Single Agent and in Combination With Everolimus & Immuno-Oncology Agents in Advanced/Relapsed Renal Cancer & Other Malignancies
Stopped: Business decision and not related to safety concerns
United States40 participantsStarted 2021-11-30
Plain-language summary
This was a first in human study of DFF332, a small molecule that targets a protein called HIF2α. By acting on HIF2α, DFF332 may be able to stop the growth of certain types of cancer. DFF332 was planned to be tested at different doses as single agent and in combination with Everolimus (RAD001, an mTOR inhibitor), and also in combination with Spartalizumab (PDR001, an anti-PD1) plus Taminadenant (NIR178, an adenosine A2A receptor antagonist), in patients with advanced clear cell renal cell carcinoma and other malignancies with HIF stabilizing mutations.
Who can participate
Age range18 Years – 100 Years
SexALL
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Inclusion criteria
✓. Male and female ≥ 18 years of age For Arm 1B: Male and female of age ≥ 12 years of age
✓. Histologically confirmed and documented clear cell renal cell carcinoma (ccRCC). Disease must be measurable as determined by RECIST v1.1.
✓. Patient with unresectable, locally advanced or metastatic ccRCC with documented disease progression following all standard of care therapy, including PD-1/L1 checkpoint inhibitor and a VEGF targeted therapy as monotherapy or in combination.
✓. For patients age ≥ 16 years: ECOG performance status ≤ 1 For patients age ≥ 12 and \< 16 years: Lansky performance status ≥ 70
Exclusion criteria
✕. History of seizure disorder \& extrapyramidal (EPS) symptoms
✕. Impaired cardiac function or clinically significant cardiac disease, including any of the following:
✕. Treatment with any of the following anti-cancer therapies prior to the first dose of study treatment within the stated timeframes:
✕. ≤ 4 weeks for radiation therapy or limited field radiation for palliation within ≤ 2 weeks prior to the first dose of study treatment.
What they're measuring
1
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Timeframe: 3 years
2
Number of participants with dose interruptions and dose reductions
Timeframe: 3 years
3
Dose intensity for DFF332 for dose escalation and expansion
Timeframe: 3 years
4
Incidence of Dose Limiting Toxicities (DLTs) in Cycle 1 (28 days) for DFF332 as a single agent and in combinations
✕. ≤ 4 weeks or ≤ 5 half-lives (whichever is shorter) for chemotherapy or biological therapy (including monoclonal antibodies) or continuous or intermittent small molecule therapeutics or any other investigational agent.
✕. ≤ 6 weeks for cytotoxic agents with major delayed toxicities, such as nitrosourea and mitomycin C.
✕. ≤ 4 weeks for immuno-oncologic therapy, such as CTLA-4, PD-1, or PD-L1 antagonists.
✕. Patients who have undergone major surgery ≤ 4 weeks prior to first dose of study treatment or who have not recovered for the surgical procedure.