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

NCT06491472 | Recruiting Phase 2

• 1 other identifier: AK112-IIT-004
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Pancreatic Cancer

Keywords

locally advanced or metastatic pancreatic cancer; Ivonescimab(AK112/SMT112); first-Line therapy; chemotherapy; SBRT

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate(ORR)

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

  Up to approximately 2 years

Secondary Outcomes (5)

• Progression-free Survival (PFS)

  Up to approximately 2 years

• Overall Survival(OS)

  Up to approximately 2 years

• Disease Control Rate (DCR)

  Up to approximately 2 years

• Adverse event (AE)

  Up to approximately 2 years

• Duration of Response(DOR)

  Up to approximately 2 years

Study Arms (1)

Ivonescimab(AK112/SMT112)+SBRT+gemcitabine+nab-paclitaxel

EXPERIMENTAL

Ivonescimab(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)

Drug: Ivonescimab; Drug: Gemcitabine; Drug: Nab paclitaxel; Radiation: SBRT

Interventions

Ivonescimab DRUG

20mg/kg,IV,d1,Q3W

Also known as: AK112/SMT112

Ivonescimab(AK112/SMT112)+SBRT+gemcitabine+nab-paclitaxel

Gemcitabine DRUG

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

Ivonescimab(AK112/SMT112)+SBRT+gemcitabine+nab-paclitaxel

Nab paclitaxel DRUG

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

Ivonescimab(AK112/SMT112)+SBRT+gemcitabine+nab-paclitaxel

SBRT RADIATION

5Gy \*5 F

Ivonescimab(AK112/SMT112)+SBRT+gemcitabine+nab-paclitaxel

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead
• Akesobio: collaborator

Study Sites (1)

Wuhan Union Hospital of China

Wuhan, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Taxes

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Economics; Health Care Economics and Organizations

Central Study Contacts

Tao Zhang

CONTACT

13808640033; 1277577866@qq.com

Study Design

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

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 9, 2024
• Study Start: July 15, 2024
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): July 15, 2027
• Last Updated: July 9, 2024

Record last verified: 2024-05

Locations

CN (1)