A Study to Evaluate the Efficacy and Safety of AK127 in Patients With Advanced Solid Tumors

NCT05393063 | Unknown Phase 1 DMC

• 1 other identifier: AK127-102
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is to characterize the safety, tolerability and anti-tumor activity of AK127 as a single agent in adult subjects with advanced solid tumor malignancies.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

• 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 21 days of treatment for dose-escalation phase and are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected or definite relationship to study drug

  During the first 21 days

Secondary Outcomes (9)

• PFS

  Up to 2 years

• ORR

  Up to 2 years

• DCR

  Up to 2 years

• DOR

  Up to 2 years

• TTR

  Up to 2 years

Study Arms (1)

AK127

EXPERIMENTAL

Subjects will receive AK127 by intravenous administration

Drug: AK127

Interventions

AK127 DRUG

Subjects will receive AK127 by intravenous administration（administered on Day 1 of each cycle, Q3W）

Also known as: Subjects will receive AK127 by intravenous administration

AK127

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.
• Not currently enrolled in any other clinical study.
• Receipt of any anticancer therapy within 4 weeks or within 5 half-lives of the drug prior to the first dose of AK127.
• Symptomatic central nervous system metastases.
• Active malignancies within the past 1 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 AK127.
• Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
• Known history of active tuberculosis.
• History of organ transplant or hematopoietic stem cell.

Sponsors & Collaborators

• Akeso: lead

Study Officials

• Shun Lu, Chief doctor

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

• Yun Fan, Chief doctor

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shun Lu, Chief doctor

CONTACT

13601813062; shun_lu@hotmail.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: May 23, 2022
• First Posted: May 26, 2022
• Study Start: June 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2024
• Last Updated: May 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share