Clinical trial · Interventional
A Study of PRT1419 in Patients With Advanced Solid Tumors
A Phase 1, Open-Label, Multicenter, Dose Escalation Study of PRT1419 in Patients With Advanced Solid Tumors
NCT04837677CI-TRIAL-00064723completedPhase 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 study of PRT1419, a myeloid cell leukemia 1 (MCL1) inhibitor, in patients with advanced solid tumors. The purpose of this study is to define the dosing schedule, maximally tolerated dose and/or estimate the optimal biological dose to be used in subsequent development of PRT1419.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PRT1419 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PRT1419
- description
- PRT1419 will be administered by intravenous infusion
- interventionNames
- Drug: PRT1419
Primary outcomes (3)
- measure
- Dose limiting toxicities (DLT) of PRT1419
- timeFrame
- Baseline through Day 28
- description
- Dose limiting toxicities will be evaluated through the first cycle
- measure
- Maximally tolerated dose (MTD) and/or optimal biological dose (OBD)
- timeFrame
- Baseline through approximately 2 years
- description
- The MTD and/or OBD 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: * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 * Adequate organ function (bone marrow, hepatic, renal, cardiovascular) * Left ventricular ejection fraction of ≥ 50% * Female patients of childbearing potential must have a negative pregnancy test within 7 days of the start of treatment and must agree to use a highly effective method of contraception during the trial * Patients must have recovered from the effects of any prior cancer related therapy, radiotherapy or surgery (toxicity ≤ Grade 1) * All patients on prior investigational agents must wait at least 5 half-lives of the agent in question, or 28 days, whichever is longer before study entry * Most recent lab values meet the following criteria: * Absolute neutrophil count \> 1.0 x 10\^3/μL; * Platelet count \> 75,000/μL; * Hemoglobin \> 9.0 g/dL * Histologically confirmed advanced or metastatic solid tumor indicated below that is relapsed, refractory, or intolerant to available therapies with known benefit: * Sarcoma not amendable to curative treatment with surgery or radiotherapy; * Melanoma (non-resectable or metastatic); * Small cell lung cancer (extensive-stage); * Non-small cell lung cancer; * Triple negative breast cancer (histopathologically or cytologically confirmed). * Esophageal cancer * Cervical cancer * Head and neck cancer Exclusion Criteria: * Known hypersensitivity to any of the components of PRT1419 * Primary malignancies of the CNS, or uncontrolled CNS metastases, including impending spinal cord compression * Female patients who are pregnant or lactating * Inflammatory disorders of the gastrointestinal tract, or subjects with GI malabsorption * Mean QTcF interval of \>480 msec * History of heart failure, additional risk factors for arrhythmias or requiring concomitant medications that prolong the QT/QTc interval * HIV positive; known active hepatitis B or C * Uncontrolled intercurrent illnesses * Treatment with strong inhibitors of CYP2C8 * Prior exposure to an MCL1 inhibitor * History of another malignancy except: * Malignancy treated with curative intent with no known active disease for \>2 years at study entry; * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; * Adequately treated carcinoma in situ without evidence of disease; * Other concurrent low-grade malignancies (i.e chronic lymphocytic leukemia (Rai 0)) may be considered after consultation with Sponsor.
References
Publications (0)
Data not yet available
No reference posted for this study.