Clinical trial NCT05559541: Study of AK119 Combined With AK104 in Patients With Advanced Solid Tumors
Official title: A Multicenter, Open-Label, Phase Ib/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of AK119 Combined With AK104 in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Solid Tumor, Adult
Lead sponsor: Akeso
Sponsor class: INDUSTRY
First posted: 2022-09-29
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Subjects must sign the written informed consent form (ICF) voluntarily.
2. Age ≥ 18 years.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status: 0 to1.
4. Life expectancy ≥12 weeks.
5. 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.
6. Subjects must have evaluable lesions according to RECIST v1.1.
7. Subjects must have adequate organ function.
8. 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.

Exclusion Criteria:

1. Prior malignancy active within the previous 3 years except for the locally curable cancers that have been apparently cured.
2. Being involved in another clinical study, except for observational clinical studies or follow-up period of interventional studies.
3. Have exposed to other products targeting T cell costimulation or immune checkpoint pathway excepts for PD-1/PD-L1 inhibitor.
4. 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.
5. 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.
6. Subjects with pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
7. 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.
8. Toxicities of prior anticancer therapy have not resolved to ≤ Grade 1 (NCI-CTCAE version 5.0).
9. Patients with clinically significant cardio-cerebrovascular or venous thromboembolic disease.
10. Active autoimmune diseases or history of autoimmune diseases that may relapse.
11. History of interstitial lung disease or noninfectious pneumonitis.
12. 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.
13. 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.
14. Receipt of live attenuated vaccines within 4 weeks prior to the first dose of investigational product.
15. Previous history of severe hypersensitivity reactions to other monoclonal antibodies.
16. Patients are pregnant or breastfeeding, or plan to breastfeed during the study.
17. Previous organ transplantation or allogeneic hematopoietic stem cell transplantation.
18. 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.

Primary outcomes:
measure: Number of subjects with dose limiting toxicities (DLTs)
timeFrame: During the first 3 or 4 weeks
measure: Number of subjects with adverse events (AEs)
timeFrame: From the time of informed consent signed through 90 days after the last dose of study drug.
measure: Objective response rate (ORR)
timeFrame: Up to 2 years
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Up to 2 years
measure: Disease control rate (DCR)
timeFrame: Up to 2 years
measure: Duration of response (DoR)
timeFrame: Up to 2 years
measure: Time to response (TTR)
timeFrame: Up to 2 years
measure: Overall survival (OS)
timeFrame: Up to 2 years
measure: PK parameters
timeFrame: From first dose of study drug through last dose
measure: Immunogenicity assessment
timeFrame: From first dose of study drug through 30 days after last dose
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Insitute & Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Cancer Insitute & Hospital
name: Jihui Hao, PhD
role: PRINCIPAL_INVESTIGATOR
References: