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

NCT05951608 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: AK127-104
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

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

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (4)

• Number of participants with adverse events (AEs)

  An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment

  From the subject signs the ICF to 30 days (AE) and 90 days (SAE) after the last dose of study treatment or initiation of other anti-tumor therapy, whichever occurs first

• Number of participants with a Dose Limiting Toxicity (DLT)

  DLTs will be assessed during the first 3 weeks of treatment for dose-escalation Ib phase and 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 first cycle (3 weeks) of treatment

  During the first 3 weeks

• Number of participants with ORR

  Efficacy measures such as overall response rate (ORR), which is the proportion of subjects with CR or PR by investigator based on RECIST v1.1

  Up to 2 years

• Progression-Free Survival

  PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first assessed by investigator Per RECIST 1.1.

  Up to 2 years

Secondary Outcomes (8)

• Disease control rate

  Up to 2 years

• Duration of response

  Up to 2 years

• Time to Progress

  Up to 2 years

• AUC of AK127 and AK112

  Up to 2 years

• PK of AK127 and AK112

  Up to 2 years

Study Arms (1)

AK127 in combination with AK112

EXPERIMENTAL

Subjects will receive AK127 in combination with AK112 by intravenous administration

Drug: AK127 in combination with AK112

Interventions

AK127 in combination with AK112 DRUG

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

AK127 in combination with AK112

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Males or females aged ≥ 18 to ≤ 75 years at the time of signing informed consent.
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
• Life expectancy ≥3 months；
• 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.
• Adequate organ function.
• Patients of childbearing potential must agree to use effective contraceptive measures.

You may not qualify if:

• The patient has received prior immunotherapy against TIGIT target.
• The patient had previously been treated with anti-PD -(L)1 and anti-VEGF targets.
• Currently enrolled in any other clinical study.
• Receipt of any anticancer therapy within 4 weeks prior to the first dose of Investigational drug;
• Symptomatic central nervous system metastases.
• Active malignancies within the past 3 years, with the exception of tumors in this study and cured local tumors
• Active autoimmune disease requiring systemic treatment prior to the start of study treatment.
• There is a history of major diseases 1 year prior to the first dose.
• Medical history of gastrointestinal perforation or gastrointestinal fistula within 6 months prior to the first dose
• Received chest radiation therapy prior to the first dose
• Presence of clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage.
• Active or previously documented inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis).
• Receipt of live or attenuated vaccination within 4 weeks prior to the first dose of Investigational drug.
• Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
• Known history of active tuberculosis.

Sponsors & Collaborators

• Akeso: lead

Study Sites (1)

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 430022, China

Location

Study Officials

• shun lu, MD

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

• yun fan, MD

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

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: July 11, 2023
• First Posted: July 19, 2023
• Study Start: October 16, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-03

Locations

CN (1)