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Small Molecule

DFF332 + Combination Therapy for Renal Cell Carcinoma

Phase 1

Waitlist Available

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study Summary

This trial will test a new drug, DFF332, to see if it can stop the growth of certain types of cancer.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include typical reactions from targeted cancer therapies such as fatigue, nausea, skin rash, increased risk of infections due to immune system suppression. Specific side effects will depend on the drug combination received.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney cancer has spread, can't be surgically removed, and has worsened after all standard treatments.

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I am 16 or older and mostly able to care for myself.

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My kidney cancer is confirmed and can be measured.

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My cancer is linked to a genetic condition or has certain gene mutations.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose intensity for DFF332 for dose escalation and expansion

Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

Incidence of Dose Limiting Toxicities (DLTs) in Cycle 1 (28 days) for DFF332 as a single agent and in combinations

+1 more

Secondary outcome measures

Area under the concentration-time curve (AUC) of DFF332 single agent and combination

Best Overall Response (BOR)

Disease Control Rate (DCR)

+4 more

Trial Design

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)

Group II: Arm 3 Dose Escalation DFF332 + Spartalizumab + TaminadenantExperimental Treatment3 Interventions

Combination treatment DFF332 + Spartalizumab + Taminadenant

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)

Group IV: Arm 2 Dose Escalation DFF332 + EverolimusExperimental Treatment2 Interventions

Combination treatment DFF332 + Everolimus

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)

Group VI: Arm 1a Dose Expansion DFF332 in ccRCCExperimental Treatment1 Intervention

DFF332 Single Agent in patients with ccRCC (age 18 years old and above)

Group VII: Arm 1 Dose Escalation DFF332Experimental Treatment1 Intervention

DFF332 Single Agent

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

RAD001

2012

Completed Phase 3

~1570

PDR001

2016

Completed Phase 2

~2700

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,855 Previous Clinical Trials

4,197,310 Total Patients Enrolled

Media Library

DFF332 (Small Molecule) Clinical Trial Eligibility Overview. Trial Name: NCT04895748 — Phase 1

Renal Cell Carcinoma Research Study Groups: Arm 3 Dose Escalation DFF332 + Spartalizumab + Taminadenant, Arm 1b Dose Expansion DFF332 in HIF stabilizing malignancies, Arm 2a Dose Expansion DFF332 + Everolimus in ccRCC, Arm 1a Dose Expansion DFF332 in ccRCC, Arm 3a Dose Expansion DFF332 + Spartalizumab + Taminadenant in ccRCC, Arm 2 Dose Escalation DFF332 + Everolimus, Arm 1 Dose Escalation DFF332

Renal Cell Carcinoma Clinical Trial 2023: DFF332 Highlights & Side Effects. Trial Name: NCT04895748 — Phase 1

DFF332 (Small Molecule) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04895748 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many healthcare institutions are currently involved in this experiment?

"Currently, this clinical trial is enrolling patients at University of Texas MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(8) in Houston, TX, Massachusetts General Hospital in Boston, MA and City of Hope National Medical Center in Duarte, CA as well as 5 additional sites."

Answered by AI

What primary medical conditions has DFF332 been proven to ameliorate?

"DFF332 has both preventative and curative applications, ranging from treating kidney transplants to combating Waldenstrom macroglobulinemia, advanced carcinoid tumor, and lung issues."

Answered by AI

What is the uppermost limit of participants for this clinical experiment?

"Novartis Pharmaceuticals is the sponsor of this clinical trial and have established multiple sites for recruitment. In order to commence with the study, 180 participants fitting the inclusion criteria are needed. Two notable locations include University of Texas MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(8) in Houston, TX and Massachusetts General Hospital located in Boston, MA."

Answered by AI

Has DFF332 been granted clearance from the FDA?

"There is limited data available to gauge the safety of DFF332, resulting in a score of 1 on our team's scale. This drug is currently undergoing Phase 1 testing and still requires further evidence for its efficacy."

Answered by AI

What are the goals of this experiment?

"The primary objective of the 28 day trial is to assess dose intensity for DFF332 in regards to escalation and expansion. Secondary outcomes include assessing Progression Free Survival (PFS) through Recommended Dose (RD), Disease Control Rate (DCR), as well as Maximum Concentration (Cmax) levels of both single agent and combination treatments, which will be assessed via plasma concentration data collected from patients with advanced ccRCC or malignancies featuring HIF stabilizing mutations."

Answered by AI

Is enrollment open for this experiment?

"Indeed, the clinicaltrials.gov website shows that recruitment for this trial has been ongoing since its initial posting on November 30th 2021 and most recently updated on October 6th 2022. Thus far, 180 individuals have volunteered to participate across 5 sites."

Answered by AI

Could you provide me with a synopsis of previous research involving DFF332?

"DFF332 was originally assessed by Sheba Medical Center in 2008. 425 trials have since been completed, with 119 currently active studies being conducted primarily out of Houston, Texas."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

DFF332 as a Single Agent and in Combination With Everolimus & Immuno-Oncology Agents in Advanced/Relapsed Renal Cancer & Other Malignancies

2021. "DFF332 as a Single Agent and in Combination With Everolimus & Immuno-Oncology Agents in Advanced/Relapsed Renal Cancer & Other Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04895748.

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