Trials / Active Not Recruiting
Active Not RecruitingNCT02974738
A Trial of Belzutifan (PT2977, MK-6482) Tablets In Patients With Advanced Solid Tumors (MK-6482-001)
A Phase 1, Dose-Escalation and Expansion Trial of PT2977, a HIF-2α Inhibitor, in Patients With Advanced Solid Tumors
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 120 (actual)
- Sponsor
- Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to identify the maximum tolerated dose (MTD) of belzutifan Tablets and/or the recommended Phase 2 dose (RP2D) of belzutifan Tablets in patients with advanced solid tumors
Detailed description
Part 1A: This is a Phase 1, multiple-dose, dose-escalation trial of belzutifan Tablets, where patients with advanced solid tumors will be assigned to sequential dose cohorts. Patient safety will be monitored with frequent physical examinations, vital sign measurements, electrocardiograms (ECGs), and hematology and chemistry laboratory studies, and by recording all adverse events (AEs). Blood will be obtained for analysis of the concentration of belzutifan and to assess biomarkers. Part 1B: Once the MTD and/or the RP2D is achieved, and expansion cohort of 50 patients with advanced clear cell renal cell carcinoma (ccRCC) will be enrolled. Part 2: After determination of the MTD/RP2D, up to 25 patients with other specified solid tumors may be enrolled. Up to 3 different tumor types may be included in this part of the study. Part 2A: A cohort of 25 patients with glioblastoma (GBM)
Conditions
- Advanced Solid Tumors
- Solid Tumor
- Solid Carcinoma
- Solid Tumor, Adult
- ccRCC
- RCC, Clear Cell Adenocarcinoma
- RCC
- Kidney Cancer
- Clear Cell Renal Cell Carcinoma
- Renal Cell Carcinoma, Metastatic
- Renal Cell Carcinoma Recurrent
- Renal Cell Carcinoma, Clear Cell Adenocarcinoma
- Glioblastoma
- Glioblastoma, Adult
- GBM
- Glioblastoma Multiforme
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Belzutifan | Belzutifan is a highly selective small molecule that inhibits the function of the HIF-2α transcription factor. As a result, hypoxic signaling in cancer cells is impaired, blocking the transcription of several genes involved in oncogenesis |
Timeline
- Start date
- 2016-12-07
- Primary completion
- 2018-01-12
- Completion
- 2027-04-14
- First posted
- 2016-11-28
- Last updated
- 2025-07-10
Source: ClinicalTrials.gov record NCT02974738. Inclusion in this directory is not an endorsement.