Study of AK119 Combined With AK112 in Patients With Advanced Solid Tumors

NCT ID: NCT05689853

Last Updated: 2023-04-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-14
• Study Completion Date: 2024-12-31

Brief Summary

This is a Phase Ib/II study to assess the safety, tolerability and preliminary efficacy of AK119 combined with AK112 in patients with advanced solid tumors.

Conditions

Solid Tumor, Adult

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AK119 in combination with AK112

AK119 and AK112, IV, every 3 weeks

Group Type: EXPERIMENTAL

AK119

Intervention Type: DRUG

AK119 is an anti-CD73 monoclonal antibody.

AK112

Intervention Type: DRUG

AK112 is a bispecific monoclonal antibody against VEGF and PD-1.

Interventions

AK119

AK119 is an anti-CD73 monoclonal antibody.

Intervention Type: DRUG

AK112

AK112 is a bispecific monoclonal antibody against VEGF and PD-1.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Voluntarily written informed consent and agree to comply with all protocol-specified procedures and follow-up evaluations

2. Age ≥ 18 years and ≤ 75 years

3. Histologically or cytologically-confirmed diagnosis of advanced/unresectable solid tumor that have been progressed or intolerant to at least one standard treatment regimen in the advanced or metastatic setting, if such a therapy exists

4. Measurable lesion based on RECIST v1.1

5. ECOG status of 0 or 1

6. Life expectancy ≥ 3 months

7. Adequate organ function

8. Women of childbearing potential and men with female partners of childbearing potential must agree to use effective contraception during treatment and for at least 120 days following the last dose of study treatment

Exclusion Criteria

1. Known other active malignancy within 3 years prior to the first dose of investigational product, with the exception of early stage cancers that have treated with curative intent

2. Currently participating in another study unless it is an observational, non-interventional clinical study or a follow-up period of an interventional study

3. Received systemic antineoplastic therapy ( e.g. chemotherapy, radiotherapy, immunotherapy) within 4 weeks prior to the first dose of investigational product; received small-molecule anticancer agents within 2 weeks prior to the first dose of investigational product

4. In addition to anti-PD-(L)1 monoclonal antibody, prior exposure to other immune checkpoint inhibitors or any other treatment directed to tumor immune mechanism

5. Prior therapy targeting CD73 or CD39 or the adenosine signalling pathway

6. Treatment with non-steroidal anti-inflammatory drugs, anti-platelet agents or anticoagulants within 7 days prior to the first dose of investigational product

7. Current dependency on systemic therapy with glucocorticoids (>10 mg/day prednisone or equivalent) or other immunosuppressive agents within 14 days prior to the first dose of investigational product

8. Presence of spinal cord compression or active brain metastases

9. Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage

10. History or presence of a serious hemorrhage or known bleeding tendency within 3 months

11. Active autoimmune disease that has required systemic treatment in past 2 years

12. Clinically significant cardiovascular disease

13. History of interstitial lung disease or noninfectious pneumonitis

14. Received systemic anti-infective therapy (excluding antiviral therapy for hepatitis B or C) within 14 days prior to the first dose of investigational product

15. Major surgical procedure or serious trauma within 28 days prior to the first dose of investigational product

16. History of immunodeficiency, human immunodeficiency virus infection (HIV)

17. Active tuberculosis or syphilis infection

18. History of organ transplantation or allogeneic haematopoietic stem cell transplantation

19. Toxicities of prior anticancer therapy have not resolved to ≤ Grade 1 (NCI-CTCAE version 5.0)

20. Any other conditions that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akeso

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wenming Wu, PhD

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ting Liu, MD

Role: CONTACT

clinicaltrials@akesobio.com

+86(0760)8987 3999

Facility Contacts

Wenming Wu, PhD

Role: primary

doctorwuu@126.com

+8613811138595

Other Identifiers

Ak119-105

Identifier Type: -

Identifier Source: org_study_id