A Phase 1, Dose-Escalation Trial of PT2385 Tablets In Patients With Advanced Clear Cell Renal Cell Carcinoma

• Status: Active, not recruiting
• Trial end date: 2022-11-30
• Target enrollment: 0
• Participant gender: All

Summary

PART 1: The primary objective of this study is to identify the maximum tolerated dose (MTD) of PT2385 Tablets and/or the recommended Phase 2 dose (RP2D) of PT2385 Tablets in patients with advanced clear cell renal cell carcinoma (ccRCC).

PART 2: The primary objective of this study is to identify the MTD of PT2385 Tablets up to the RP2D, in combination with nivolumab, in patients with advanced ccRCC.

PART 3: The primary objective of this study is to identify the MTD of PT2385 Tablets up to the RP2D, in combination with cabozantinib tablets, in patients with advanced ccRCC.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peloton Therapeutics, Inc.
• Treatments: Antibodies, Monoclonal; Nivolumab

Criteria

Inclusion Criteria

PART 1

• Has locally advanced or metastatic ccRCC and has progressed during treatment with at least one prior therapeutic regimen

• Is of age ≥ 18 years

• Has a life expectancy of ≥ 3 months

• Has adequate organ function

• If a female patient, must be surgically sterile, post-menopausal, or must agree to use physician-approved method of birth control during the study and for a minimum of 30 days after the last study drug administration, or if a male patient with a female partner, must agree to use physician-approved method of birth control during the study and for a minimum of 30 days after the last study drug administration

• Able to swallow oral medications

PART 2 - In addition to PART 1

• Received no more than three prior systemic treatment regimens in the advanced or metastatic setting

• Must have received at least one but not more than two prior anti-angiogenic therapy regimens

PART 3 - In addition to PART 1

• Must have received at least one vascular endothelial growth factor receptor (VEGFR) targeting tyrosine kinase inhibitor

Exclusion Criteria

PART 1

• Has a history of untreated brain metastasis or history of leptomeningeal disease or spinal cord compression

• Has failed to recover from the reversible effects of prior anticancer therapy

• Has uncontrolled or poorly controlled hypertension

• Is receiving warfarin anticoagulant therapy or expected to require warfarin

• Has had any major cardiovascular event within 6 months prior to study drug administration

• Has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with participation in the trial or interfere with the interpretation of trial results

• Has had major surgery within 4 weeks before first study drug administration

• Has known HIV

• Has an active infection requiring systemic treatment

• Is participating in another therapeutic clinical trial

PART 2 - In addition to PART 1

• Has received prior immunotherapy

• Has any active or recent history of a known or suspected autoimmune disease

PART 3 - In addition to PART 1

• Gastrointestinal (GI) disorders

• Any history of congenital long QT syndrome