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Pancreatic Ductal Adenocarcinoma (PDAC)Phase 2NCT07694973

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

A Phase 2 study testing Inavolisib in people with Pancreatic Ductal Adenocarcinoma (PDAC), run by Fudan University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Ductal Adenocarcinoma (PDAC)
What is being tested?
Inavolisib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteChina
Study dates
29 Aug 2026to 29 Jul 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1.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.
  • 5.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.
  • 6.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.
  • 7.ECOG Performance status (PS) of 0 or 1 within 7 days prior to initiation of study treatment.
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  • 8.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
  • Serum creatinine ≤ 1.5 × ULN or Creatinine clearance ≥ 60 mL/min (calculated using the Cockcroft-Gault formula)
  • Albumin ≥ 25 g/L (2.5 g/dL)
  • For patients not receiving therapeutic anticoagulation: INR and aPTT ≤ 1.5 × ULN
  • For patients receiving therapeutic anticoagulation: stable anticoagulant regimen 10.Negative HIV test at screening 11.For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs, as defined below: Women must remain abstinent or use non-hormonal contraceptive methods with a failure rate of < 1% per year during the treatment period and for at least 1 week after the final dose of study treatment. Women must refrain from donating eggs during this same period.
  • A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). The definition of childbearing potential may be adapted for alignment with local guidelines or regulations. Examples of non-hormonal contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
  • 12.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.
  • The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. If required per local guidelines or regulations, information about the reliability of abstinence will be described in the local Informed Consent Form.

Who cannot join

  • 1.Prior treatment with any PI3K, AKT, or mTOR inhibitor, or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway.
  • 2.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.
  • 5.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.
  • 6.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
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  • 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.
  • 10.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.
  • 12.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.
  • 16.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.
  • 19.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
  • New York Heart Association Class III or IV cardiac disease or congestive heart failure requiring medication
  • Uncontrolled arrhythmias, history of or active ventricular arrhythmia requiring medication
  • Coronary heart disease that is symptomatic or unstable angina
  • Congenital long QT syndrome or QT interval corrected through use of Fridericia's formula > 470 ms demonstrated by at least two ECGs > 30 minutes apart, or family history of sudden unexplained death or long QT syndrome 27.Clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia) 28.Chronic corticosteroid therapy of ≥ 10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids or immunosuppressants for a chronic disease 29.Treatment with strong CYP3A4 inducers or strong CYP3A4 inhibitors within 1 week or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study treatment 30.Pregnant, lactating, or breastfeeding, or intending to become pregnant during the study or within 60 days after the final dose of study treatment.
  • Women of childbearing potential (including those who have had a tubal ligation) must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment or negative urine pregnancy test if serum pregnancy test is not available.
  • 31.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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xianjun Yu contact

+86+13801669875

yuxianjun@fudanpci.org

Miaoyan Wei contact

+86+13801669875

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai

    Xianjun Yu, +86+13801669875, yuxianjun@fudanpci.org

    Miaoyan Wei, +86+13801669875

Other trials in China

About this study

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）.

Read more

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).

Being tested
Inavolisib
Keywords
Pancreatic ductal adenocarcinoma (PDAC), INAVOLISIB, Phase II

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InavolisibDrug

    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

Study groups in NCT07694973
Study groupRoleWhat they receive
ExperimentalExperimentalinavolisib
Receives: Drug: Inavolisib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (5)

  1. Progression free survival（PFS）

    defined as the time between the date of first dose of Inavolisib and the date of disease progression assessed by investigator according to RECIST v1.1 or death due to any cause (whichever occurs first). Subjects who are alive and have not progressed, whether on-study or lost to follow-up will be censored at their last evaluable tumor assessment date.

    Measured: 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

  2. Overall survival（OS）

    defined as the time from treatment starting with Inavolisib to death due to any cause. Subjects without events will be censored at the date last known to be alive.

    Measured: from treatment starting with Inavolisib to death due to any cause

  3. Disease control rate（DCR）

    defined as the proportion of patients in whom the best overall response is determined as complete response (CR), partial response (PR) or stable disease (SD) and status last >= 4 weeks.Response will be assessed by the investigator according to RECIST v1.1

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

  4. Duration of response (DOR)

    ●The duration of response is defined as time from first evidence of PR or CR to disease progression or death due to any cause. DOR will be calculated only for subjects who achieve a confirmed response of PR or CR.

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

  5. Time to response (TTR)

    defined as the time from the start of first dose of Inavolisib until the first evidence of PR or CR. TTR will be calculated only for subjects who achieve a response of confirmed PR or better.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2026
  2. Study start29 Aug 2026 (estimated)
  3. Primary completion29 Jun 2028 (estimated)
  4. Study completion29 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
62 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07694973
Sponsor's protocol ID
ML46544
Status last verified
Jun 2026
First submitted
25 Jun 2026
Last updated
10 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Inavolisib in people with Pancreatic Ductal Adenocarcinoma (PDAC), run by Fudan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xianjun Yu (+86+13801669875, yuxianjun@fudanpci.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: CR and PR require confirmatory CT or MRI repeat assessment at least 4 weeks after the first detection of response.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07694973.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.

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