Study of AK119 Combined With AK104 in Patients With Advanced Solid Tumors

NCT05559541 | Terminated Phase 1

• 1 other identifier: AK119-104
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase Ib/II Study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of AK119 combined with AK104 in tumor patients.

Conditions

Solid Tumor, Adult

Outcome Measures

Primary Outcomes (3)

• Number of subjects with dose limiting toxicities (DLTs)

  DLTs will be assessed during the first 3 or 4 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 3 or 4 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 (7)

• 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

• Overall survival (OS)

  Up to 2 years

Study Arms (1)

AK119+AK104

EXPERIMENTAL

AK119 and AK104 IV every 2 or every 3 weeks.

Drug: AK119; Drug: AK104

Interventions

AK119 DRUG

AK119 is an anti-CD73 monoclonal antibody.

AK119+AK104

AK104 DRUG

AK104 is an anti-PD-1 and CTLA-4 bispecific antibody.

AK119+AK104

Eligibility Criteria

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

You may qualify if:

• Subjects must sign the written informed consent form (ICF) voluntarily.
• Age ≥ 18 years.
• Eastern Cooperative Oncology Group (ECOG) Performance Status: 0 to1.
• Life expectancy ≥12 weeks.
• Subjects must have histologically or cytologically confirmed advanced solid tumor that is refractory or relapsed to the current standard therapies, or for which no effective standard therapy is available.
• Subjects must have evaluable lesions according to RECIST v1.1.
• Subjects must have adequate organ function.
• Female subjects of childbearing potential and male subjects with female partners of childbearing potential must agree to use effective barrier methods of contraception during the study and for 120 days after last dose of study drug.

You may not qualify if:

• Prior malignancy active within the previous 3 years except for the locally curable cancers that have been apparently cured.
• Being involved in another clinical study, except for observational clinical studies or follow-up period of interventional studies.
• Have exposed to other products targeting T cell costimulation or immune checkpoint pathway excepts for PD-1/PD-L1 inhibitor.
• Anticancer therapy (e.g., chemotherapy, radiotherapy, etc.) within 4 weeks prior to the first dose of investigational product; Anticancer small-molecule targeted agent (e.g., tyrosine kinase inhibitor) within 2 weeks prior to the first dose of investigational product.
• Subjects with spinal cord compression or active brain metastases, except for subjects with untreated and asymptomatic brain metastases or with stable brain metastases after treatment.
• Subjects with pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
• Subjects whose imaging shows that the tumor has invaded important blood vessels or the investigator judges that the tumor is very likely to invade important blood vessels and cause fatal bleeding during the study.
• Toxicities of prior anticancer therapy have not resolved to ≤ Grade 1 (NCI-CTCAE version 5.0).
• Patients with clinically significant cardio-cerebrovascular or venous thromboembolic disease.
• Active autoimmune diseases or history of autoimmune diseases that may relapse.
• History of interstitial lung disease or noninfectious pneumonitis.
• Major surgery or trauma within 4 weeks prior to first dose of investigational product. Unhealed wound, ulcer or fracture within 4 weeks prior to first dose of investigational product.
• Any condition that required systemic treatment with corticosteroids (\> 10 mg daily prednisone or equivalent) or other immunosuppressive agents within 14 days prior to the first dose of investigational product.
• Receipt of live attenuated vaccines within 4 weeks prior to the first dose of investigational product.
• Previous history of severe hypersensitivity reactions to other monoclonal antibodies.

Sponsors & Collaborators

• Akeso: lead

Study Sites (1)

Tianjin Medical University Cancer Insitute & Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

Study Officials

• Jihui Hao, PhD

  Tianjin Medical University Cancer Insitute & Hospital

  PRINCIPAL INVESTIGATOR

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: September 26, 2022
• First Posted: September 29, 2022
• Study Start: December 15, 2022
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: February 19, 2025

Record last verified: 2025-02

Locations

CN (1)