Clinical trial · Interventional
A Phase Ib/II Study of the Combination of BYL719 Plus AMG 479 in Adult Patients With Selected Solid Tumors
- 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 was a multi-center, open-label, phase Ib/II study. The aim of the phase Ib part was to estimate the MTD(s) and/or identify the recommended phase II dose(s) (RP2Ds) for the combination of BYL719 and AMG 479 (ganitumab), followed by the phase II part to assess the clinical efficacy and to further assess the safety of the combination in selected patient populations. Patients were to be treated until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. All patients were to be followed up. At a minimum, patients must have completed the safety follow-up assessments 30 days after the last dose of the study treatment.
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 |
|---|---|---|---|
| PIK3CA Amplified Advanced Solid Tumors | — | UNRESOLVED | — |
| PIK3CA Mutated Advanced Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BYL719 + AMG 479
- description
- For: Dose escalation phase/Phase II Expansion Phase. Cohorts of 3-6 patients were to be enrolled sequentially until an MTD or a recommended Phase II dose were defined. All patients were to receive the combination treatment. Sequential cohorts may receive different doses of the combination. In the Phase II expansion, all patients were to receive the same combination treatment.
- interventionNames
- Drug: BYL719
- Drug: AMG 479
Primary outcomes (2)
- measure
- Dose Limiting Toxicities (DLTs) - Phase Ib
- timeFrame
- 28 days
- description
- Phase lb only
- measure
- Percentage of Patients With Overall Response Rate (RECIST) Based on Investigator Radiology Assessment for HR Positive Breast and Ovarian Cancer - Phase II
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key inclusion criteria: * Written informed consent. * Patients aged ≥ 18 years (male or female). * Patients with the following histologically/cytologically-confirmed advanced solid tumors with documented somatic PIK3CA mutations or amplifications in tumor tissue: * Hormone receptor positive breast carcinoma * Ovarian carcinoma * Other tumors upon agreement with sponsor * Adequate organ function * Negative serum pregnancy test Key exclusion criteria: * Patients with known history of severe infusion reactions to monoclonal antibodies. * Patients with primary CNS tumor or CNS tumor involvement. * History of thromboembolic event requiring full-dose anti-coagulation therapy any time prior to enrollment. * Clinically significant cardiac disease. * History of another malignancy within last 2 years. * Pregnant or nursing (lactating) women.
References
Publications (0)
Data not yet available