A Multicenter, Single Arm Study to Evaluate the Preliminary Efficacy and Safety Profile of Inavolisib in Previously Treated Pancreatic Ductal Adenocarcinoma Patients

NCT07694973 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: ML46544
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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. Tumor tissue (via biopsies and/or surgical resection) and blood samples from eligible patients will be provided to a local laboratory and tested and analyzed for biomarkers that might be associated with clinical benefit, tumor immunobiology, mechanisms of resistance, et al. Patients will be closely monitored for adverse events throughout the study, including the incidence, nature and severity of adverse events and laboratory abnormalities graded per National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE 5.0).

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC)

Keywords

Pancreatic ductal adenocarcinoma (PDAC); INAVOLISIB; Phase II

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  defined as the proportion of patients with a complete response (CR) or partial response (PR). Response will be assessed by the investigator according to RECIST v1.1. CR and PR require confirmatory CT or MRI repeat assessment at least 4 weeks after the first detection of response.

  CR and PR require confirmatory CT or MRI repeat assessment at least 4 weeks after the first detection of response.

Secondary Outcomes (5)

• Progression free survival（PFS）

  From date of first dose of Inavolisib until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 15 months

• Overall survival（OS）

  from treatment starting with Inavolisib to death due to any cause

• Disease control rate（DCR）

  complete response (CR), partial response (PR) or stable disease (SD) and status last >= 4 weeks

• Duration of response (DOR)

  from first evidence of PR or CR to disease progression or death due to any cause，assessed up to 15months

• Time to response (TTR)

  from the start of first dose of Inavolisib until the first evidence of PR or CR，assessed up to 15 months

Study Arms (1)

Experimental

EXPERIMENTAL

inavolisib

Drug: Inavolisib

Interventions

Inavolisib DRUG

Safety run in stage: Inavolisib 9mg P.O. QD under 3+3 design If Inavolisib 9mg is not tolerable Inavolisib 6mg P.O. QD under 3+3 design Expansion stage: Inavolisib 9mg P.O. QD or Inavolisib 6mg P.O. QD follow the results in safety run in stage

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• At least one measurable lesion per RECIST v1.1 9.Adequate hematologic and organ function, defined by the following laboratory test results, obtained within 7 days prior to initiation of study treatment:
• ANC ≥ 1.5 × 109/L (1500/μL) without granulocyte colony-stimulating factor support
• Lymphocyte count ≥ 0.5 × 109/L (500/μL)
• Platelet count ≥ 100 × 109/L (100,000/μL) without transfusion
• Hemoglobin ≥ 90 g/L (9 g/dL) Patients may be transfused to meet this criterion, but must not have been transfused within 2 weeks prior to screening
• Fasting glucose \< 6.1.mmol/L and HbA1c \< 5.7%
• AST, ALT, and alkaline phosphatase (ALP) ≤ 2.5 × upper limit of normal (ULN).
• Total bilirubin ≤ 1.5 × ULN with the following exception:
• Patients with known Gilbert disease: total bilirubin ≤ 3 × ULN

You may not qualify if:

• 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
• Radiographic demonstration of improvement upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic assessments
• Screening CNS radiographic assessments ≥ 4 weeks since completion of radiotherapy
• No history of intracranial hemorrhage or spinal cord hemorrhage 9.Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures biweekly or more frequently Indwelling pleural or abdominal catheters may be allowed, provided the patient has adequately recovered from the procedure, is hemodynamically stable and symptomatically improved, and has prior approval from the Medical Monitor.
• Serious infection requiring IV antibiotics within 7 days prior to Day 1 of Cycle 1 11.Any concurrent ocular or intraocular condition excluding cataracts (e.g. , diabetic retinopathy) that, in the opinion of the investigator, would require medical or surgical intervention during the study period to prevent or treat vision loss that might result from that condition.
• Active inflammatory (e.g., uveitis or vitritis) or infectious (e.g., conjunctivitis, keratitis, scleritis, or endophthalmitis) conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye 13.Requirement for daily supplemental oxygen 14.Symptomatic active lung disease, including pneumonitis 15.History of or active inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis) Patients currently receiving immunosuppressants for inflammatory bowel disease (e.g., sulfasalazines) are considered to have active disease and are therefore ineligible.
• Any active bowel inflammation (including diverticulitis) 17.Any serious medical condition or abnormality in clinical laboratory tests that precludes an individual's safe participation in and completion of the study 18.Symptomatic hypercalcemia requiring continued use of bisphosphonate or denosumab therapy Bisphosphonate and denosumab therapy for bone metastases or osteopenia/osteoporosis is allowed.
• Clinically significant and active liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis 20.Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, metabolic, or infectious disease) or any other diseases, active or uncontrolled pulmonary dysfunction, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results, or that renders the patient at high risk from treatment complications 21.Chemotherapy, radiotherapy, or any other anti-cancer therapy within 2 weeks before study treatment 22.Investigational drug(s) within 4 weeks before study treatment 23.Prior radiotherapy to ≥ 25% of bone marrow, or hematopoietic stem cell or bone marrow transplantation 24.Unresolved toxicity from prior therapy, except for hot flashes, alopecia, and Grade ≤ 2 peripheral neuropathy 25.History of other malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer 26.History of or active clinically significant cardiovascular dysfunction, including the following:
• History of stroke or transient ischemic attack within 6 months prior to first dose of study treatment
• History of myocardial infarction within 6 months prior to first dose of study treatment

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

Location

MeSH Terms

Interventions

inavolisib

Study Officials

• Xianjun YV

  Fudan University

  STUDY CHAIR

Central Study Contacts

Xianjun Yu

CONTACT

+86+13801669875; yuxianjun@fudanpci.org

Miaoyan Wei

CONTACT

+86+13801669875

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 10, 2026
• Study Start (Estimated): August 29, 2026
• Primary Completion (Estimated): June 29, 2028
• Study Completion (Estimated): July 29, 2028
• Last Updated: July 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)