Clinical trial · Interventional
An Initial Safety Study of Gedatolisib Plus PTK7-ADC for Metastatic Triple-negative Breast Cancer
NCT03243331CI-TRIAL-00049300completedPhase 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)
Phase 1 study to evaluate the safety and effect of Gedatolisib and PTK7-ADC for the treatment of triple negative breast cancer
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gedatolisib | Drug | — | UNRESOLVED |
| PTK7-ADC | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gedatolisb + PTK7-ADC
- interventionNames
- Drug: Gedatolisib
- Drug: PTK7-ADC
Primary outcomes (1)
- measure
- Safety of Gedatolisb + PTK7-ADC using NCI CTCAE v4.0
- timeFrame
- through study completion i.e. up to 1 year
- description
- safety and toxicity data will be assessed using NCI CTCAE v4.0 and tabulated and reported
Secondary outcomes (6)
- measure
- Efficacy in all enrolled subjects
- timeFrame
- 18 weeks
- description
- efficacy as determined by clinical benefit at 18 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Metastatic Triple-negative Breast Cancer * Willingness to undergo tumor biopsy * Patients must have received at least 1 prior chemotherapy regimen for metastatic disease Exclusion Criteria: * Previous treatment with mTOR inhibitor * Untreated brain metastases
References
Publications (0)
Data not yet available
No reference posted for this study.