Advanced Solid Tumor study: Rezatapopt vs Pembrolizumab
Official title The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)
ClinicalTrials.gov ID: NCT04585750
What this study is testing
What is rezatapopt?
An investigational oral medicine being studied for advanced solid tumors that have a specific TP53 Y220C mutation. It is designed to reactivate the p53 protein in cancer cells that carry the Y220C mutation.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see how safe and effective rezatapopt is for patients with locally advanced or metastatic solid tumors that carry the TP53 Y220C mutation. It also looks at how the drug works with the immune drug pembrolizumab.
- Who it's for
- It is looking for adults who have advanced or metastatic solid tumors that have the TP53 Y220C mutation.
- What's involved
- Participants will receive rezatapopt alone, and in part of the study they may also receive the immune drug pembrolizumab. They will have regular visits for drug administration and medical tests to monitor safety and tumor response.
- Time commitment
- The study lasts several months, with multiple clinic visits for drug doses, blood tests, imaging scans, and follow‑up assessments.
- Phase 2: a mid-size study of how well it works
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- At least 18 years of age or 12 to 17 years of age after Safety Review Committee approval.
- Locally advanced or metastatic solid malignancy with a TP53 Y220C mutation
- Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
- Previously treated with one or more lines of anticancer therapy and progressive disease
- Adequate organ function
You likely can't join if
- Anti-cancer therapy within 21 days (or 5 half-lives) of receiving the study drug
- Radiotherapy within 14 days of receiving the study drug
- Primary CNS tumor
- History of leptomeningeal disease or spinal cord compression
- Brain metastases, unless neurologically stable and do not require steroids to treat associated neurological symptoms
- Stroke or transient ischemic attack within 6 months prior to screening
See the full eligibility criteria
- At least 18 years of age or 12 to 17 years of age after Safety Review Committee approval.
- Locally advanced or metastatic solid malignancy with a TP53 Y220C mutation
- Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
- Previously treated with one or more lines of anticancer therapy and progressive disease
- Adequate organ function
- Measurable disease per RECIST v1.1 (Phase 2) Additional Criteria for Inclusion in Phase 1b (rezatapopt) + pembrolizumab combination)
- Anti-PD-1/PD-L1 naive or must have progressed on treatment
- Measurable disease
- Anti-cancer therapy within 21 days (or 5 half-lives) of receiving the study drug
- Radiotherapy within 14 days of receiving the study drug
- Primary CNS tumor
- History of leptomeningeal disease or spinal cord compression
- Brain metastases, unless neurologically stable and do not require steroids to treat associated neurological symptoms
- Stroke or transient ischemic attack within 6 months prior to screening
- Heart conditions such as unstable angina within 6 months prior to screening, uncontrolled hypertension, a heart attack within 6 months prior to screening, congestive heart failure, prolongation of QT interval, or other...
- Strong CYP3A4 inducers and strong CYP2C9 inhibitors/inducers within 14 days of first dose of rezatapopt
- History of gastrointestinal (GI) disease that may interfere with absorption of study drug or patients unable to take oral medication
- History of prior organ transplant
- Known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer
- Known, active uncontrolled Hepatitis B, Hepatitis C, or human immunodeficiency virus infection Additional Criteria for Exclusion from Phase 2 (rezatapopt monotherapy)
- Known KRAS mutation, defined as a single nucleotide variant (SNV) (Phase 2). Exception: Ovarian cancer patients with a known KRAS SNV are permitted.
- Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and discontinued from that treatment due to a Grade 3 or higher...
- Received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention
- Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy within 7 days prior to the first dose of study drug
- Hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients
- Active autoimmune disease that has required systemic treatment in past 2 years
- History of radiation pneumonitis
- History of (non-infectious) or active pneumonitis / interstitial lung disease that required steroids
- Active infection requiring systemic therapy
- Known history of HIV infection
- Has previously received rezatapopt
The study team makes the final eligibility decision.
Where it is enrolling
- La Jolla, California, United States
- Los Angeles, California, United States
- Denver, Colorado, United States
- New Haven, Connecticut, United States
- Newark, Delaware, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Port Charlotte, Florida, United States
- Boston, Massachusetts, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Cleveland, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- York, Pennsylvania, United States
- Nashville, Tennessee, United States
- Austin, Texas, United States
- Bedford, Texas, United States
+ 40 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at La Jolla, California, United States; Los Angeles, California, United States; Denver, Colorado, United States; New Haven, Connecticut, United States; Newark, Delaware, United States; Miami, Florida, United States and 54 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.