Pilot Study of Casdatifan-Treated Refractory Renal Cell Carcinoma

Conditions

• Refractory Renal Cell Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - 100 Years

Healthy Volunteers

Not accepted

Interventions

• casdatifan — DRUG
  Casdatifan will be taken orally at a fixed dose of 100 mg once daily, with or without food, on a continuous schedule beginning on Cycle 1, Day 1.

Study Details

This is a single-institution, pilot study of oral casdatifan, a selective HIF-2α inhibitor, in patients with metastatic clear cell renal cell carcinoma refractory to prior IO- and VEGF-based therapies. The study will assess changes in HIF2-regulated gene expression through RNA sequencing of serial tumor biopsies obtained at baseline, during treatment, and at progression. Blood samples will also be collected for future analyses.

Key Dates

First listed

Aug 6, 2026

Start date

Jul 1, 2029

Status verified

Jul 2026

Primary completion

Jul 1, 2030

Completion

Jan 1, 2031

Study Design

Enrollment

12 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Casdatifan
  Casdatifan will be taken orally at a fixed dose of 100 mg once daily, with or without food, on a continuous schedule beginning on Cycle 1, Day 1.

Primary Outcome Measure

To determine the change in expression of predefined HIF2-regulated target genes in metastatic tumor tissue following casdatifan therapy in a refractory ccRCC population. [ Time Frame: 1 year ]

Central Contacts

• Vanderbilt-Ingram Services for Timely Access
  800-811-8480
  [email protected]

Locations (1)

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