A Phase I Study of DFF332, Alone or with Everolimus or Other Anticancer Drugs, to Treat Advanced Kidney Cancer

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Full Title

A Phase I/Ib, Open Label, Multi-center Study of DFF332 as a Single Agent and in Combination with Everolimus or IO Agents in Patients with Advanced / Relapsed ccRCC and Other Malignancies with HIF2a Stabilizing Mutations

Purpose

The purpose of this study is to find the highest and safest dose of the investigational drug DFF332 that can be given alone or in combination with other anticancer drugs in people with advanced clear cell renal cell carcinoma that cannot be successfully treated with standard therapies. Clear cell renal cell carcinoma is the most common form of kidney cancer.

There will be two groups of patients participating in this study. The first group includes those with clear cell renal cell carcinoma. The second group includes patients whose cancer has a genetic change in specific genes, including VHL, FH, SDH, EPAS/HIF2, or ELOC/TCEB1. These mutated genes play a major role in the survival and growth of cancer cells, and are sometimes responsible for syndromes that predispose people to hereditary kidney cancers. Many of these lead to a disorder in a protein called HIF2-alpha; DFF332 targets and blocks this protein, which may slow or stop cancer growth.

Participants in this study will receive one of these treatments:

  • DFF332 alone
  • DFF332 with everolimus
  • DFF332 plus taminadenant and spartalizumab

Spartalizumab (a type of immunotherapy) is given intravenously (by vein) and the other medications are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • In one group, participants must have inoperable or metastatic clear cell renal cell cancer that persists despite prior treatment that included immunotherapy and targeted therapy.
  • In the other group, a patient’s cancer must contain a mutation in one of these genes: VHL, FH, SDH, EPAS1/HIF2A, or ELOC/TCEB1.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

For more information and to ask about eligibility for this study, please contact the office of Dr. Ritesh Kotecha at 646-422-4839.

Protocol

21-513

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators