Study of Orellanine in Metastatic Clear-Cell or Papillary Renal Cell Carcinoma

Part of paid clinical trials in Palo Alto, California.

Sponsor
Oncorena AB
Study ID
NCT05287945
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Carcinoma, Renal Cell

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Orellanine — DRUG
    Orellanine administered intravenously

Study Details

A phase I/II, open-label, study to determine the safety and preliminary efficacy of orellanine in patients with metastatic clear-cell or papillary renal carcinoma who have failed standard-of-care therapy. All participants must have end-stage kidney disease and be receiving stable chronic hemodialysis.

Key Dates

Start date
Aug 4, 2023
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
75 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Part B - 24-Hour Exposure Cohort
    Participants receive orellanine (ONC175) as a 30 minute intravenous infusion once during each 28 day treatment cycle. Hemodialysis is performed the day before the infusion and again approximately 24 hours after the infusion to define the exposure period, as orellanine is eliminated primarily through dialysis. Participants will continue their regular hemodialysis schedule throughout the cycle.
  • Experimental: Part B - 72 Hour Exposure Cohort
    Participants receive orellanine (ONC175) as a 30 minute intravenous infusion once during each 28 day treatment cycle. In this cohort, hemodialysis is performed on the morning of the infusion, and additional hemodialysis sessions occur on the following days. Replacement doses of orellanine may be administered on the days after the initial infusion, depending on the assigned dose level. Hemodialysis is performed approximately 72 hours after the initial infusion to define the extended exposure period, as orellanine is eliminated primarily through dialysis.

Primary Outcome Measure

Adverse events and laboratory abnormalities as graded by NCI CTCAE v5.0. [ Time Frame: Through study completion, approximately 1 year ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
StanfordPalo AltoCalifornia94304
Sandhya Srinivas, M.D.
[email protected]
650-498-6000
Sandhya Srinivas, MD (PRINCIPAL_INVESTIGATOR)
Washington University in St. LouisSt LouisMissouri63130
Melissa Reimers, M.D.
[email protected]
314-273-3713
Melissa Reimers, MD (PRINCIPAL_INVESTIGATOR)
University of Texas - MD Anderson Cancer CenterHoustonTexas77030
Nizar Tannir, M.D.
[email protected]
713-563-7265
Nizar Tannir, M.D. (PRINCIPAL_INVESTIGATOR)

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