AK137 (Bispecific Antibody Targeting CD73 and LAG-3) in Patients With Advanced Malignant Tumors

NCT ID: NCT06691360

Last Updated: 2024-11-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-31
• Study Completion Date: 2027-08-31

Brief Summary

A Phase I open label, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and antitumor activity of AK137 in patients with advanced malignant tumors.

Conditions

Advanced Malignant Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AK137

Each subject will receive a single dose of AK137 every 3-week cycle (Q3W) or every 2-week cycle (Q2W). Participants may continue on study drug until unacceptable toxicity, or other withdrawal criteria is met.

Group Type: EXPERIMENTAL

AK137

Intervention Type: DRUG

IV infusion, specified dose on specified days.

Interventions

AK137

IV infusion, specified dose on specified days.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Written and signed informed consent.

2. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.

3. Life expectancy ≥3 months.

4. 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.

5. Subject must have at least one measurable lesion according to RECIST Version1.1.

6. Adequate organ function.

Exclusion Criteria

1. Any malignancy other than the disease under study within the past 3 years except for radically cured local cancers, such as basal cell skin cancer, carcinoma in situ of the cervix, or carcinoma in situ of breast.

2. Receipt of any anti-CD73, anti-LAG-3 treatment.

3. Experienced a toxicity that led to the permanent discontinuation of prior immunotherapy. All adverse events (AEs) while receiving prior immunotherapy have not completely resolved or resolved to Grade 1 prior to screening. Additionally, the use of immunosuppression other than corticosteroids was required.

5. Major surgical procedure within 4 weeks prior to the first dose of AK137 or still recovering from prior surgery.

6. History of organ transplant.

7. Known allergy or reaction to any component of the AK137 formulation. History of severe hypersensitivity reactions to other mAbs.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akeso

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Pulmonary Hospital

Shanghai, , China

Countries

China

Central Contacts

Xufang Yu

Role: CONTACT

clinicaltrials@akesobio.com

+86(0760)89873999

Facility Contacts

Shengxiang Ren

Role: primary

Other Identifiers

AK137-101

Identifier Type: -

Identifier Source: org_study_id