A Multicenter, Single Arm Study to Evaluate the Preliminary Efficacy and Safety Profile of Inavol… (NCT07694973) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Multicenter, Single Arm Study to Evaluate the Preliminary Efficacy and Safety Profile of Inavolisib in Previously Treated Pancreatic Ductal Adenocarcinoma Patients
China62 participantsStarted 2026-08-29
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
.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.
.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:
2.For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, as defined below: With a female partner of childbearing potential or pregnant female partner, men must remain abstinent or use a condom during the treatment period and for at least 1 week after the final dose of study treatment to avoid exposing the embryo. Men must refrain from donating sperm during this same period.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective response rate (ORR)
Timeframe: CR and PR require confirmatory CT or MRI repeat assessment at least 4 weeks after the first detection of response.
.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:
0.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.
2.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.
6.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.
9.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:
1.Major surgical procedure, or significant traumatic injury, within 28 days prior to Day 1 of Cycle 1 or anticipation of the need for major surgery during the course of study treatment 32.Minor surgical procedures \<7 days prior to first dose of study treatment. Patients must have sufficiently recovered from surgery, including adequate wound healing.