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AN0025 and Chemoradiotherapy Combination in Esophageal Cancer

Primary Purpose

Esophageal Cancer

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
AN0025
Sponsored by
Adlai Nortye Biopharma Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosed with histologically- and/or cytologically-confirmed locally advanced/locally recurrent squamous cell carcinoma or adenocarcinoma of the esophagus or of the esophagogastric junction (EGJ).
  2. Male or female, age≥18 years at the time of informed consent.
  3. Have provided signed informed consent for the trial and are willing to comply with all aspects of the protocol

Exclusion Criteria:

  1. With a history of another primary malignancy within the past 2 years, with the exception of basal or squamous cell skin cancer, or carcinoma in situ of the cervix or breast that has undergone potentially curative therapy.
  2. Participants with known Hepatitis B or C infections, or known to be positive for Hepatitis B antigen (HBsAg)/ Hepatitis B virus (HBV) DNA or Hepatitis C antibody (HepC Ab)/ Hepatitis C virus (HCV) RNA. Active Hepatitis B is defined by a known positive HepB Ab result and known quantitative HBV DNA results greater than the lower limits of detection of the assay. Active Hepatitis C is defined by a known positive HepC Ab result and known quantitative HCV RNA results greater than the lower limits of detection of the assay.
  3. Participants with known human immunodeficiency virus (HIV) infection (positive for HIV-1/2 antibody) or syphilis infection (positive for syphilis spiral antibody).
  4. Major surgery or severe trauma within 4 weeks before the first dose of study drug. Note: If participant received major surgery, they must have recovered adequately from surgery and the toxicity and/or complications requiring the intervention prior to starting study treatment.
  5. Have received prior systemic anti-cancer therapy including chemotherapy, target therapy, immunotherapy, anti-cancer traditional Chinese medicine, and other investigational oncology agents within 4 weeks or 5 half-lives, whichever is shorter. Participants who have entered the follow-up phase of an investigational study may participate as long as it has been at least 4 weeks (or 5 half-lives, whichever is shorter) after the last dose of the previous investigational agent.

    Note: Participants must have recovered from all AEs due to previous therapies to ≤ Grade 1 or returned to baseline. Participants with ≤ Grade 2 neuropathy or alopecia (per CTCAE v5.0) may be eligible.

  6. Are currently participating in a study of an investigational device within 4 prior to the first dose of study treatment.
  7. Have uncontrolled tumor-related pain.
  8. Have a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
  9. Have a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.

Sites / Locations

  • Jianming XuRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with unresectable locally advanced/locally recurrent esophageal cancer

Arm Description

Patients will receive AN0025 orally once daily (QD) and chemoradiotherapy followed by the maintenance of AN0025

Outcomes

Primary Outcome Measures

Number of participants with Dose Limiting Toxicities (DLTs)
DLTs are defined as study drug-related toxicities graded using Common Terminology Criteria for Adverse events of the National Cancer Institute (NCI CTCAE) V5.0 occurring during DLT period (the first 4 weeks of AN0025 administration in combination with dCRT)

Secondary Outcome Measures

Complete response rate (CRR)
The rate of patients with complete response in all tumor evaluable patients
Objective response rate (ORR)
The rate of patients with complete response and partial response in all tumor evaluable patients
Disease control rate (DCR)
The rate of patients with complete response, partial response and stable disease in all tumor evaluable patients
Progression-free survival (PFS)
The duration from the date of 1st dose to imageological progression or death, which earlier
Overall survival (OS)
The duration from the date of 1st dose to death

Full Information

First Posted
December 26, 2021
Last Updated
March 27, 2023
Sponsor
Adlai Nortye Biopharma Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05191667
Brief Title
AN0025 and Chemoradiotherapy Combination in Esophageal Cancer
Official Title
An Open-Label Multicenter Phase Ib Study of AN0025 in Combination With Chemoradiotherapy in Patients With Locally Advanced/Locally Recurrent Esophageal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 18, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Adlai Nortye Biopharma Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is an open-label, multicenter, phase Ib study to evaluate the safety, tolerability, and preliminary efficacy of AN0025 in combination with chemoradiotherapy (CRT) in patients with locally advanced/locally recurrent esophageal cancer.
Detailed Description
This study will enroll patients with unresectable locally advanced/locally recurrent esophageal cancer or esophagogastric junction cancer to assess the safety and tolerability of AN0025 at 250mg QD and 500mg QD combined with concurrent chemoradiotherapy to fix the MTD or RP2D. At RP2D level, another 20 patients with unresectable locally advanced/locally recurrent esophageal cancer or esophagogastric junction cancer will be enrolled at PR2D dose level to explore the preliminary efficacy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with unresectable locally advanced/locally recurrent esophageal cancer
Arm Type
Experimental
Arm Description
Patients will receive AN0025 orally once daily (QD) and chemoradiotherapy followed by the maintenance of AN0025
Intervention Type
Drug
Intervention Name(s)
AN0025
Other Intervention Name(s)
Paclitaxel, Carboplatin, Radiotherapy
Intervention Description
250 mg or 500 mg Q.D., oral administration
Primary Outcome Measure Information:
Title
Number of participants with Dose Limiting Toxicities (DLTs)
Description
DLTs are defined as study drug-related toxicities graded using Common Terminology Criteria for Adverse events of the National Cancer Institute (NCI CTCAE) V5.0 occurring during DLT period (the first 4 weeks of AN0025 administration in combination with dCRT)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Complete response rate (CRR)
Description
The rate of patients with complete response in all tumor evaluable patients
Time Frame
2 years
Title
Objective response rate (ORR)
Description
The rate of patients with complete response and partial response in all tumor evaluable patients
Time Frame
2 years
Title
Disease control rate (DCR)
Description
The rate of patients with complete response, partial response and stable disease in all tumor evaluable patients
Time Frame
2 years
Title
Progression-free survival (PFS)
Description
The duration from the date of 1st dose to imageological progression or death, which earlier
Time Frame
2 years
Title
Overall survival (OS)
Description
The duration from the date of 1st dose to death
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with histologically- and/or cytologically-confirmed locally advanced/locally recurrent squamous cell carcinoma or adenocarcinoma of the esophagus or of the esophagogastric junction (EGJ). Male or female, age≥18 years at the time of informed consent. Have provided signed informed consent for the trial and are willing to comply with all aspects of the protocol Exclusion Criteria: With a history of another primary malignancy within the past 2 years, with the exception of basal or squamous cell skin cancer, or carcinoma in situ of the cervix or breast that has undergone potentially curative therapy. Participants with known Hepatitis B or C infections, or known to be positive for Hepatitis B antigen (HBsAg)/ Hepatitis B virus (HBV) DNA or Hepatitis C antibody (HepC Ab)/ Hepatitis C virus (HCV) RNA. Active Hepatitis B is defined by a known positive HepB Ab result and known quantitative HBV DNA results greater than the lower limits of detection of the assay. Active Hepatitis C is defined by a known positive HepC Ab result and known quantitative HCV RNA results greater than the lower limits of detection of the assay. Participants with known human immunodeficiency virus (HIV) infection (positive for HIV-1/2 antibody) or syphilis infection (positive for syphilis spiral antibody). Major surgery or severe trauma within 4 weeks before the first dose of study drug. Note: If participant received major surgery, they must have recovered adequately from surgery and the toxicity and/or complications requiring the intervention prior to starting study treatment. Have received prior systemic anti-cancer therapy including chemotherapy, target therapy, immunotherapy, anti-cancer traditional Chinese medicine, and other investigational oncology agents within 4 weeks or 5 half-lives, whichever is shorter. Participants who have entered the follow-up phase of an investigational study may participate as long as it has been at least 4 weeks (or 5 half-lives, whichever is shorter) after the last dose of the previous investigational agent. Note: Participants must have recovered from all AEs due to previous therapies to ≤ Grade 1 or returned to baseline. Participants with ≤ Grade 2 neuropathy or alopecia (per CTCAE v5.0) may be eligible. Are currently participating in a study of an investigational device within 4 prior to the first dose of study treatment. Have uncontrolled tumor-related pain. Have a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study. Have a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianming Xu, MD
Phone
010-66937876
Email
Jianmingxu2014@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianming Xu, MD
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jianming Xu
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianming Xu, MD
Phone
010-66937876
Email
Jianmingxu2014@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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AN0025 and Chemoradiotherapy Combination in Esophageal Cancer

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