NCT07694973
A Multicenter, Single Arm Study to Evaluate the Preliminary Efficacy and Safety Profile of Inavolisib in Previously Treated Pancreatic Ductal Adenocarcinoma Patients
Not Yet Recruiting · Phase 2 · Fudan University · registry updated 2026-07-10
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
This is a phase II, multicenter, single arm study designed to evaluate the efficacy and safety of Inavolisib in second line pancreatic ductal adenocarcinoma（PDAC） patients. This study will be conducted in two stages and expected to enroll up to approximately 62 patients. In the safety run in stage, approximately up to 12 patients will be enrolled to receive Inavolisib under 3+3 design. After safety run-in, if the tolerability allows, an additional 50 patients will be enrolled.（expansion stage）. Dose Modification Guidelines for Inavolisib-Related Adverse Events: Inavolisib started at dose 9 mg QD, first reduction to 6 mg QD, second reduction to 3 mg QD. If the patient continues to experience specified drug-related adverse events after the second dose reduction, Inavolisib should be permanently discontinued. Tumor assessments will be performed every 8 weeks, including enhanced chest CT, abdominal CT / MRI and pelvic CT / MRI.Head CT/MRI also can be performed if necessary. Additional scans will be performed as clinically indicated. Tumor specimens acquired from biopsy will be collected for E-cadherin testing by IHC at each site....
Inclusion
- Signed Informed Consent Form 2.Age ≥ 18 years at time of signing Informed Consent Form 3.Ability to comply with the study protocol, in the investigator's judgment 4.Histologically or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma.
- The disease must have progressed after previous chemotherapy given in a neoadjuvant, adjuvant (only if distant metastases occurred within 6 months of completing adjuvant therapy), 1st line therapy of locally advanced, or metastatic setting.
- Availability of a representative tumor specimen that is suitable for pathological evaluation and biomarker expression analysis.
- A formalin-fixed, paraffin-embedded (FFPE) tumor specimen in approximately 8-10 slides containing unstained, freshly cut, serial sections should be submitted along with an associated pathology report within 4 weeks of randomization.
- If fewer than 8 slides are obtained, but there are enough slides for E-cadherin testing by local lab of each site patients are still eligible.
- ECOG Performance status (PS) of 0 or 1 within 7 days prior to initiation of study treatment.
Exclusion
- Prior treatment with any PI3K, AKT, or mTOR inhibitor, or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway.
- Prior treatment with any RAS inhibitor or BRCA inhibitor. 3.Known hypersensitivity to any of the components of study treatments. 4.Histology consistent with small cell carcinoma, Neuroendocrine carcinoma, or mixed carcinoma.
- Type 2 diabetes requires ongoing systemic treatment at the time of study entry;or pre-diabetes, or any history of Type 1 diabetes；or any other type of diabetes.
- Inability or unwillingness to swallow pills 7.Malabsorption syndrome or other condition that would interfere with enteral absorption 8.Known and untreated, or active CNS metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control). Patients with a history of treated CNS metastases are eligible, provided they meet all of the following criteria:
- Measurable disease outside the CNS
- No ongoing requirement for corticosteroids as therapy for CNS metastases, with corticosteroids discontinued for ≥ 2 weeks prior to enrollment and no ongoing symptoms attributed to CNS metastases