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Recruiting NCT05689853

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

Phase I / Phase II Interventional Solid Tumor, Adult

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AK119, AK112.
Who it may be relevant to
Registry conditions: Solid Tumor, Adult. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Open-label, Multicenter, Phase Ib/II Study to Evaluate the Safety, Tolerability and Antitumor Activity of AK119 in Combination With AK112 in Patients With Advanced Solid Tumors

Overview

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.

Interventions

  • Drug AK119
    AK119 is an anti-CD73 monoclonal antibody.
  • Drug AK112
    AK112 is a bispecific monoclonal antibody against VEGF and PD-1.

Primary outcome measures

  • Number of subjects with dose limiting toxicities (DLTs) [Time frame: During the first three weeks]
  • Number of subjects with adverse events (AEs) [Time frame: From the time of informed consent signed through 90 days after the last dose of study drug.]
  • Objective Response Rate (ORR) [Time frame: Up to 2 years]
Secondary outcome measures (6)
  • Progression free survival (PFS) [Time frame: Up to 2 years]
  • Disease control rate (DCR) [Time frame: Up to 2 years]
  • Duration of response (DoR) [Time frame: Up to 2 years]
  • Time to response (TTR) [Time frame: Up to 2 years]
  • Time to progression (TTP) [Time frame: Up to 2 years]
  • Overall survival (OS) [Time frame: Up to 2 years]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • History of immunodeficiency, human immunodeficiency virus infection (HIV)
  • Active tuberculosis or syphilis infection
  • History of organ transplantation or allogeneic haematopoietic stem cell transplantation
  • Toxicities of prior anticancer therapy have not resolved to ≤ Grade 1 (NCI-CTCAE version 5.0)
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking Union Medical College Hospital — Beijing

Identifiers

NCT: NCT05689853 · Ak119-105

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗