Clinical trial · Interventional
A Study of PRT2527 in Participants With Advanced Solid Tumors
A Phase 1, Open-Label, Multicenter, Dose Escalation and Confirmation Study of PRT2527 in Participants With Advanced Solid Tumors
NCT05159518CI-TRIAL-00072134completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Phase 1 dose-escalation and confirmation study of PRT2527, a Cyclin-dependent Kinase 9 (CDK9) inhibitor, in participants with advanced solid tumors. The purpose of this study is to define the dosing schedule, and maximally tolerated dose to be used in subsequent development of PRT2527.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Castrate Resistant Prostate Cancer | — | UNRESOLVED | — |
| Hormone Receptor Positive HER2 Negative Breast Cancer | — | UNRESOLVED | — |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Solid Tumors With Known MYC Amplification | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PRT2527 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PRT2527
- description
- PRT2527 will be administered by intravenous infusion
- interventionNames
- Drug: PRT2527
Primary outcomes (3)
- measure
- Dose limiting toxicities (DLT) of PRT2527
- timeFrame
- Baseline through Day 21
- description
- Dose limiting toxicities will be evaluated over the 21-day observation period
- measure
- Maximally tolerated dose (MTD) of PRT2527
- timeFrame
- Baseline through approximately 1 year
- description
- The MTD will be established for further investigation in participants with advanced solid tumors
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Tumor types under study 1. Selected sarcomas with a documented gene fusion 2. Castrate resistant prostate cancer (CRPC) 3. Hormone receptor positive (HR+), HER2 negative (HER2-) breast cancer 4. Non-small cell lung cancer (NSCLC) 5. MYC amplified solid tumors * Must have measurable disease per RECIST 1.1; participants with CRPC or sarcoma may have nonmeasurable but evaluable disease * Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1 * Adequate organ function * Must provide tumor tissue sample to the central laboratory for biomarker analysis * Participants must have recovered from the effects of prior cancer-related therapy, radiotherapy, or surgery to ≤ Grade 1 Exclusion Criteria: * Primary malignancies of the CNS, or uncontrolled CNS metastases, including impending spinal cord compression * have a corrected QT interval \>480 msec from prior or baseline * have impaired cardiac function or clinically significant cardiac disease * Treatment with strong inhibitors or inducers of CYP3A4 * Prior exposure to a CDK9 inhibitor * History of another malignancy except for: 1. Curatively treated malignancy with no known active disease 2. Curatively treated non-melanoma skin cancer without evidence of disease 3. Curatively treated carcinoma in situ without evidence of disease * have undergone major surgery within 2 weeks prior to Week 1 Day 1 * have had chemotherapy, biologic therapy, targeted therapy, immunotherapy, extended-field radiotherapy, or investigational agents within 5 half-lives or 28 days (whichever is shorter) prior to administration of the first dose of study drug on Week 1 Day 1.
References
Publications (0)
Data not yet available
No reference posted for this study.