A Phase Ib/II Clinical Study of AK127 in Combination With AK112 in Patients With Advanced Solid Tumors

NCT ID: NCT05951608

Last Updated: 2023-07-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-31
• Study Completion Date: 2026-07-31

Brief Summary

A Phase Ib/II Open-label Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of AK127 in combination with AK112 in Patients with Advanced Malignant Tumors

Detailed Description

The study consisted of two parts. The first part, Phase Ib is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity of AK127 in combination with AK112 in adult subjects with advanced solid tumor malignancies. The part, as a dose escalation phase is to determine the maximum tolerated dose (MTD), or recommended Phase 2 dose (RP2D) for AK127 in combination with AK112, and describe Dose Limiting Toxicity (DLT).The second part, Phase II is to Evaluate the anti-tumor activity of AK127 in combination with AK112 in different tumor species cohorts.

Conditions

Advanced Solid Tumors

Study Design

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

Study Groups

AK127 in combination with AK112

Subjects will receive AK127 in combination with AK112 by intravenous administration

Group Type: EXPERIMENTAL

AK127 in combination with AK112

Intervention Type: DRUG

AK127 in combination with AK112 (administered on Day 1 of each cycle, Q3W) up to 2 years

Interventions

AK127 in combination with AK112

AK127 in combination with AK112 (administered on Day 1 of each cycle, Q3W) up to 2 years

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Ability to understand and voluntarily sign a written informed consent form (ICF), which must be signed before the specified study procedures required for the study are performed.

2. Males or females aged ≥ 18 to ≤ 75 years at the time of signing informed consent.

3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.

4. Life expectancy ≥3 months；

5. Histologically or cytologically documented advanced or metastatic solid tumor that is refractory/relapsed to standard therapies, or for which no effective standard therapy is available, or the subject is not suitable for standard therapy.

6. Adequate organ function.

7. Patients of childbearing potential must agree to use effective contraceptive measures.

Exclusion Criteria

1. The patient has received prior immunotherapy against TIGIT target.

2. The patient had previously been treated with anti-PD -(L)1 and anti-VEGF targets.

3. Currently enrolled in any other clinical study.

4. Receipt of any anticancer therapy within 4 weeks prior to the first dose of Investigational drug;

5. Symptomatic central nervous system metastases.

6. Active malignancies within the past 3 years, with the exception of tumors in this study and cured local tumors

7. Active autoimmune disease requiring systemic treatment prior to the start of study treatment.

8. There is a history of major diseases 1 year prior to the first dose.

9. Medical history of gastrointestinal perforation or gastrointestinal fistula within 6 months prior to the first dose

10. Received chest radiation therapy prior to the first dose

11. Presence of clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage.

12. Active or previously documented inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis).

13. Receipt of live or attenuated vaccination within 4 weeks prior to the first dose of Investigational drug.

14. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).

15. Known history of active tuberculosis.

16. History of organ transplant or hematopoietic stem cell.

17. History of primary immunodeficiency.

18. Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.

19. Other cases deemed inappropriate by the investigator.

• 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

Principal Investigators

shun lu, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Chest Hospital

yun fan, MD

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Cancer Hospital

Central Contacts

yong b li, PHD

Role: CONTACT

baiyong.li@akesobio.com

13023250310

Other Identifiers

AK127-104

Identifier Type: -

Identifier Source: org_study_id