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

NCT05689853 | Recruiting Phase 1

• 1 other identifier: Ak119-105
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Number of subjects with dose limiting toxicities (DLTs)

  DLTs will be assessed during the first three weeks of treatment. DLTs are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the DLT observation period.

  During the first three weeks

• Number of subjects with adverse events (AEs)

  AE refers to any untoward medical occurrence or deterioration of existing medical event after the subject signed the ICF, whether or not considered related to the study treatment.

  From the time of informed consent signed through 90 days after the last dose of study drug.

• Objective Response Rate (ORR)

  ORR is defined as the proportion of subjects with CR or PR (based on RECIST Version 1.1).

  Up to 2 years

Secondary Outcomes (6)

• Progression free survival (PFS)

  Up to 2 years

• Disease control rate (DCR)

  Up to 2 years

• Duration of response (DoR)

  Up to 2 years

• Time to response (TTR)

  Up to 2 years

• Time to progression (TTP)

  Up to 2 years

Study Arms (1)

AK119 in combination with AK112

EXPERIMENTAL

AK119 and AK112, IV, every 3 weeks

Drug: AK119; Drug: AK112

Interventions

AK119 DRUG

AK119 is an anti-CD73 monoclonal antibody.

AK119 in combination with AK112

AK112 DRUG

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

AK119 in combination with AK112

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily written informed consent and agree to comply with all protocol-specified procedures and follow-up evaluations
• Age ≥ 18 years and ≤ 75 years
• 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
• Measurable lesion based on RECIST v1.1
• ECOG status of 0 or 1
• Life expectancy ≥ 3 months
• Adequate organ function
• 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

You may not qualify if:

• 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
• Currently participating in another study unless it is an observational, non-interventional clinical study or a follow-up period of an interventional study
• 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
• 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
• Prior therapy targeting CD73 or CD39 or the adenosine signalling pathway
• Treatment with non-steroidal anti-inflammatory drugs, anti-platelet agents or anticoagulants within 7 days prior to the first dose of investigational product
• 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
• Presence of spinal cord compression or active brain metastases
• Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage
• History or presence of a serious hemorrhage or known bleeding tendency within 3 months
• Active autoimmune disease that has required systemic treatment in past 2 years
• Clinically significant cardiovascular disease
• History of interstitial lung disease or noninfectious pneumonitis
• Received systemic anti-infective therapy (excluding antiviral therapy for hepatitis B or C) within 14 days prior to the first dose of investigational product
• Major surgical procedure or serious trauma within 28 days prior to the first dose of investigational product

Sponsors & Collaborators

• Akeso: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100005, China

RECRUITING

Study Officials

• Wenming Wu, PhD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ting Liu, MD

CONTACT

+86(0760)8987 3999; clinicaltrials@akesobio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: January 19, 2023
• Study Start: April 14, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

CN (1)