A Study of AK131 in Patients With Advanced Solid Tumors

NCT06166888 | Recruiting Phase 1

• 1 other identifier: AK131-101
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase Ia/Ib study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of AK131 in advanced solid tumor patients

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Number of subjects with dose limiting toxicities (DLTs)

  DLTs will be assessed during the first 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 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

Secondary Outcomes (8)

• Serum PK concentration of AK131

  From first dose of study drug through 30 days after last dose of study drug

• Number of subjects who develop detectable anti-drug antibodies (ADAs)

  From first dose of study drug through 30 days after last dose of study drug

• Objective response rate (ORR)

  Up to approximately 2 years

• Disease control rate (DCR)

  Up to approximately 2 years

• Progression-free survival (PFS)

  Up to approximately 2 years

Study Arms (1)

AK131

EXPERIMENTAL

Subjects will receive AK131 via intravenously (IV) Q2W or Q3W, up to 2 years

Drug: AK131

Interventions

AK131 DRUG

AK131 is an anti-PD-1 and CD73 bispecific antibody

AK131

Eligibility Criteria

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

You may qualify if:

• Written and signed informed consent.
• Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.
• Life expectancy ≥3 months.
• Histologically or cytologically documented unresectable advanced or metastatic malignant tumor that has failed or intolerant of standard therapy, or for which no effective standard therapy is available.
• Subject must have at least one measurable lesion according to RECIST Version1.1.
• 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:

• Any malignancy other than the disease under study within the past 3 years except for radically cured local cancers.
• Being involved in another clinical study, except for observational clinical studies or follow-up period of interventional studies.
• Receipt of any anti-CD73 treatment.
• Anticancer therapy within 4 weeks prior to the first dose of investigational product.
• Experienced a toxicity that led to permanent discontinuation of prior immunotherapy.
• 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.
• Patients with clinically significant cardio-cerebrovascular disease.
• Active autoimmune diseases or history of autoimmune diseases that may relapse.
• History of interstitial lung disease or noninfectious pneumonitis.
• Major surgery, trauma,unhealed wound, ulcer or fracture within 4 weeks prior to first dose of investigational product.
• Any condition that required systemic treatment with corticosteroids 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.

Sponsors & Collaborators

• Akeso: lead

Study Sites (1)

Jinming Yu

Jinan, Shandong, 250117, China

RECRUITING

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: December 4, 2023
• First Posted: December 12, 2023
• Study Start: January 10, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)