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Pancreatic CancerPhase 2NCT06491472

Ivonescimab(AK112/SMT112) in Combination With Stereotactic Body Radiation Therapy and Chemotherapy in Patients With Pancreatic Cancer

A Phase 2 study testing Ivonescimab, Gemcitabine and Nab paclitaxel in people with Pancreatic Cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study is an open-label, single-arm Phase II clinical study to evaluate the efficacy and safety of ivonescimab(AK112/SMT112) in combination with stereotactic body radiation therapy and chemotherapy in patients with pancreatic cancer Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
Ivonescimab, Gemcitabine and Nab paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteChina
Study dates
15 Jul 2024to 15 Jul 2027
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

  • Be able and willing to provide written informed consent and comply with all requirements of study participation (including all study procedures).
  • Histologically- or cytologically-confirmed diagnosis of pancreatic ductal adenocarcinoma (including adenosquamous carcinoma)
  • Have a life expectancy of at least 3 months.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator
  • No previous history of radiotherapy or no overlap between the secondary radiotherapy site and the original radiotherapy site
  • Has adequate organ function
  • All female and male subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment.

Who cannot join

  • Has known active brain metastases or meningeal metastases
  • Compression fractures of the spine not treated with surgery and/or radiation; Treated spinal compression fractures require stable disease for at least 2 weeks randomization
  • There was a high risk of gastrointestinal bleeding or abdominal bleeding
  • Uncontrolled cancer pain; Anesthetic painkillers did not reach a stable dose at the time of enrollment
  • During the initial 72 hours of the study, patients experienced a weight loss of 10 percent or more compared to their initial body weight when they signed the ICF
  • Within 72 hours prior to the study, the subjects' ECOG physical status score increased by ≥1 point compared to the score at ICF signing.
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  • Unable to lie flat or for 10-20 minutes with radiotherapy.
  • Prior exposure to any agent targeting T cell costimulation or immune checkpoint pathways (e.g., anti-PD 1, anti-PD L1, anti-PD L2, anti-CTLA 4, anti CD137 or anti-OX40 antibody, etc)
  • Known germ line BRAC1/2 mutation
  • Liver metastases account for more than 50% of the total liver volume
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy within 2 years before the first dose of study treatment;
  • Received chemotherapy, tyrosine kinase inhibitors, immunotherapy (such as interleukin, interferon or thymosin) and other anti-tumor therapy within 28 days before the study, and received Chinese medicine with anti-tumor indications within 14 days before the administration
  • Has undergone major surgery within 30 days prior to the first dose of study treatment
  • Has received radical radiotherapy within 3 months before the study; Palliative radiotherapy was allowed 2 weeks before administration, and the radiotherapy dose was in line with local palliative treatment standards
  • Systemic corticosteroids (>10 mg/ day of prednisone or equivalent equivalent of other corticosteroids, continuous treatment ≥7 days) or immunosuppressant therapy were required during the first 14 days of the study; Except inhaled or topical use of hormones, or physiological replacement dose of hormone therapy due to adrenal insufficiency; Short-term (≤7 days) corticosteroids are permitted for prevention (e.g., contrast agent allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity caused by exposure to allergens)
  • has a decline in albumin that was difficult to correct
  • Has received a live virus vaccine within 28 days prior to first dose of study treatment.
  • Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
  • Has an active infection requiring systemic therapy
  • Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected)
  • History of myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or surgery within 6 months prior to day 1 of study treatment
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of this subject to participate, in the opinion of the treating investigator
  • Has received a live virus vaccine within 28 days prior to first dose of study treatment
  • Is pregnant, breastfeeding, or expecting to conceive or father a child within the projected duration of the study including 120 days following the last dose of study treatment.
  • Other cases deemed inappropriate by the investigator.

Trial locations and contacts

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

Tao Zhang contact

13808640033

1277577866@qq.com

China1 site, 1 recruiting

  • Wuhan Union Hospital of China

    Wuhan

    Tao Zhang, 13808640033, 1277577866@qq.com

    Recruiting

Other trials in China

About this study

Official title: Efficacy and Safety of Ivonescimab(AK112/SMT112) in Combination With Stereotactic Body Radiation Therapy and Chemotherapy in Patients With Pancreatic Cancer：A Single-arm, Open-label, Phase II Clinical Study

This study is an open-label, single-arm Phase II clinical study to evaluate the efficacy and safety of ivonescimab(AK112/SMT112) in combination with stereotactic body radiation therapy and chemotherapy in patients with pancreatic cancer

Being tested
Ivonescimab, Gemcitabine, Nab paclitaxel, SBRT
Keywords
locally advanced or metastatic pancreatic cancer, Ivonescimab(AK112/SMT112), first-Line therapy, chemotherapy, SBRT
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • IvonescimabDrug

    Also called AK112/SMT112

    20mg/kg,IV,d1,Q3W

  • GemcitabineDrug

    1000mg/m2, IV, d1/8, Q3W

  • Nab paclitaxelDrug

    125mg/m2, IV, d1/8, Q3W

  • SBRTRadiation

    5Gy *5 F

Study groups in NCT06491472
Study groupRoleWhat they receive
Ivonescimab(AK112/SMT112)+SBRT+gemcitabine+nab-paclitaxelExperimentalIvonescimab(AK112/SMT112) (20mg/kg,Q3W) +gemcitabine(1000 mg/m²,IV, d1/8, Q3W)+nab-paclitaxel(25mg/m2, IV, d1/8, Q3W) +SBRT(5Gy *5 F)
Receives: Drug: Ivonescimab; Drug: Gemcitabine; Drug: Nab paclitaxel; Radiation: SBRT

What is being measured

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

  1. Objective Response Rate(ORR)

    ORR is the proportion of subjects with CR or PR , based on RECIST v1.1.

    Measured: Up to approximately 2 years

Secondary outcomes (5)

  1. Progression-free Survival (PFS)

    PFS is defined as the time from the date of first dosing till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the investigator or death due to any cause (whichever occurs first).

    Measured: Up to approximately 2 years

  2. Overall Survival(OS)

    OS is the time from the date of randomization or first dosing date to death due to any cause.

    Measured: Up to approximately 2 years

  3. Disease Control Rate (DCR)

    DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST Version 1.1

    Measured: Up to approximately 2 years

  4. Adverse event (AE)

    Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and clinically significant abnormal laboratory results

    Measured: Up to approximately 2 years

  5. Duration of Response(DOR)

    Time from first documented response (CR or PR) until documented disease progression or death, whichever occurs first

    Measured: Up to approximately 2 years

Timeline

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

  1. First posted9 Jul 2024
  2. Study start15 Jul 2024 (estimated)
  3. Primary completion15 Jul 2026 (estimated)
  4. Study completion15 Jul 2027 (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
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06491472
Sponsor's protocol ID
AK112-IIT-004
Status last verified
May 2024
First submitted
27 Jun 2024
Last updated
9 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ivonescimab, Gemcitabine and Nab paclitaxel in people with Pancreatic Cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 8 inclusion and 25 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: looking for participants now, as of the sponsor's last update on 9 Jul 2024. 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 Tao Zhang (13808640033, 1277577866@qq.com), 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: Up to approximately 2 years). 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 NCT06491472.

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 9 Jul 2024.

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