West Cancer Center

RENAL: PHASE 1: Metastatic RCC; Combo H1F2a with nivo or cabo: “PT2385-101”

A phase I, multiple-dose, dose-escalation trial of PT2385 tablets, a HIF-2alpha inhibitor, in patients with advanced clear cell renal cell carcinoma

Title

Peloton PT2385-101

Study Title

A phase I, multiple-dose, dose-escalation trial of PT2385 tablets, a HIF-2alpha inhibitor, in patients with advanced clear cell renal cell carcinoma

Site Link

NCT02293980

Malignancy

Renal cell carcinoma, RCC. kidney cancer, clear cell RCC

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

2nd line, 3rd line, 4th line

Investigational Agent

PT2385

Drug Class

HIF-2 alpha inhibitor

Dan Vaena, MD

Sponsor

Peloton Therapeutics, Inc.

Phase

Phase 1

Status

Closed to Accrual

Key Eligibility Criteria

NCT02293980

Key Eligibility Criteria Details

Locally advanced or metastatic clear cell RCC
Must have progressed on treatment with at least 1, but no more than 2, VEGF-TKIs
Must have had no more than three prior lines of systemic therapy in advanced/metastatic setting
No current CNS mets
No known HIV
No uncontrolled or poorly controlled hypertension
May not be receiving warfarin
FOR NIVO ARM ONLY- no prior immunotherapy, no history of autoimmune disease, no history of CNS mets

Objective

Primary- MTD of combinations: Secondary- Safety, PK, PD, antitumor activity

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Clear cell, or clear cell component

Dosing Frequency

Control Agents

Study Protocol

Randomized