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

NCT06691360 | Not Yet Recruiting Phase 1

• 1 other identifier: AK137-101
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• AEs

  Incidence and severity of participants with adverse events

  From time ICF is signed until 90 days after last dose of AK137

• DLT

  During the first 28-day of treatment with AK137

Secondary Outcomes (9)

• Objective Response Rate (ORR)

  Up to approximately 2 years

• Disease Control Rate (DCR)

  Up to approximately 2 years

• Duration of Response (DoR)

  Up to approximately 2 years

• Time to response (TTR)

  Up to approximately 2 years

• Progression Free Survival (PFS)

  Up to approximately 2 years

Study Arms (1)

AK137

EXPERIMENTAL

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.

Drug: AK137

Interventions

AK137 DRUG

IV infusion, specified dose on specified days.

AK137

Eligibility Criteria

• Age: 18 Years - 75 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.

You may not qualify if:

• 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.
• Receipt of any anti-CD73, anti-LAG-3 treatment.
• 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.
• Major surgical procedure within 4 weeks prior to the first dose of AK137 or still recovering from prior surgery.
• History of organ transplant.
• Known allergy or reaction to any component of the AK137 formulation. History of severe hypersensitivity reactions to other mAbs.

Sponsors & Collaborators

• Akeso: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, China

Location

Central Study Contacts

Xufang Yu

CONTACT

+86(0760)89873999; clinicaltrials@akesobio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 15, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: November 15, 2024

Record last verified: 2024-11

Locations

CN (1)