DFF332 + Combination Therapy for Renal Cell Carcinoma
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: Novartis Pharmaceuticals
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial is testing a new drug called DFF332 in patients with advanced kidney cancer and other cancers with certain genetic mutations. The drug works by blocking a protein that helps the cancer grow.
Eligibility Criteria
This trial is for adults with advanced clear cell renal cancer (ccRCC) who've tried all standard treatments, including PD-1/L1 inhibitors and VEGF therapies. It's also open to those with certain genetic mutations or syndromes related to other cancers, as long as they have no remaining standard treatment options. People can't join if they have heart issues, uncontrolled illnesses like high blood pressure or infections, recent major surgery, or are pregnant.Inclusion Criteria
My kidney cancer has spread, can't be surgically removed, and has worsened after all standard treatments.
I am 16 or older and mostly able to care for myself.
My kidney cancer is confirmed and can be measured.
My cancer is linked to a genetic condition or has certain gene mutations.
Exclusion Criteria
I have been treated with a HIF2α inhibitor before.
I have a history of seizures and movement disorders.
I had major surgery less than 4 weeks ago or haven't recovered from it.
I have heart problems that affect my daily activities.
I do not have any uncontrolled illnesses like high blood pressure or active infections.
Treatment Details
The study tests DFF332 alone and combined with Everolimus (RAD001), Spartalizumab (PDR001), and Taminadenant (NIR178). These drugs target different aspects of cancer growth: HIF2α protein by DFF332; mTOR pathway by RAD001; immune checkpoints by PDR001; and adenosine A2A receptors by NIR178.
7Treatment groups
Experimental Treatment
Group I: Arm 3a Dose Expansion DFF332 + Spartalizumab + Taminadenant in ccRCCExperimental Treatment3 Interventions
Combination treatment DFF332 + Spartalizumab + Taminadenant in patients with ccRCC (age 18 years old and above). This arm will not open.
Group II: Arm 3 Dose Escalation DFF332 + Spartalizumab + TaminadenantExperimental Treatment3 Interventions
Combination treatment DFF332 + Spartalizumab + Taminadenant. This arm will not open.
Group III: Arm 2a Dose Expansion DFF332 + Everolimus in ccRCCExperimental Treatment2 Interventions
Combination treatment DFF332 + Everolimus in patients with ccRCC (age 18 years old and above). This arm will not open.
Group IV: Arm 2 Dose Escalation DFF332 + EverolimusExperimental Treatment2 Interventions
Combination treatment DFF332 + Everolimus. This arm will not open.
Group V: Arm 1b Dose Expansion DFF332 in HIF stabilizing malignanciesExperimental Treatment1 Intervention
DFF332 Single Agent in patients with HIF stabilizing malignancies (age 12 years old and above). This arm will not open.
Group VI: Arm 1a Dose Expansion DFF332 in ccRCCExperimental Treatment1 Intervention
DFF332 Single Agent in patients with ccRCC (age 18 years old and above). This arm will not open.
Group VII: Arm 1 Dose Escalation DFF332Experimental Treatment1 Intervention
DFF332 Single Agent
Find a clinic near you
Research locations nearbySelect from list below to view details:
Washington Uni School of Med Main CenterSaint Louis, MO
Washington University School Main CenterSaint Louis, MO
WA Uni School Of MedSaint Louis, MO
Memorial Sloane Ketterin Cancer CtrNew York, NY
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Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor