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AN0025 and Chemoradiotherapy Combination in Esophageal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05191667
Recruitment Status : Not yet recruiting
First Posted : January 13, 2022
Last Update Posted : January 13, 2022
Sponsor:
Information provided by (Responsible Party):
Adlai Nortye Biopharma Co., Ltd.

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. This study will enroll different cohorts of patients based on the assessment of original lesions, including patients that can be surgically resected with potential (but primary resection without CRT is unlikely to achieve clear margins as defined by MRI), patients with unresectable locally advanced esophageal cancer or esophagogastric junction cancer, and patients with unresectable locally recurrent esophageal cancer or esophagogastric junction cancer where the recurrent region has not received radiotherapy. Histologic classification can be squamous cell carcinoma or adenocarcinoma.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Drug: AN0025 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Multicenter Phase Ib Study of AN0025 in Combination With Chemoradiotherapy in Patients With Locally Advanced/Locally Recurrent Esophageal Cancer
Estimated Study Start Date : January 2022
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ph1: Patients that can be surgically resected with potential
Patients will receive AN0025 orally once daily (QD) and chemoradiotherapy as neoadjuvant treatment followed by a surgery
Drug: AN0025
250 mg or 500 mg Q.D., oral administration

Experimental: Ph1: Patients can be surgically resected with potential but are evaluated as inoperable later
Patients will receive AN0025 orally once daily (QD) and chemoradiotherapy as neoadjuvant treatment followed by a radical chemoradiotherapy.
Drug: AN0025
250 mg or 500 mg Q.D., oral administration

Experimental: Ph1: Patients with unresectable locally advanced/locally recurrent esophageal cancer
Patients will receive AN0025 orally once daily (QD) and chemoradiotherapy.
Drug: AN0025
250 mg or 500 mg Q.D., oral administration




Primary Outcome Measures :
  1. Number of participants with Dose Limiting Toxicities (DLTs) [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. The rate of histopathologically confirmed complete response (pCR) rate [ Time Frame: 2 years ]
  2. R0 resection rate [ Time Frame: 2 years ]
  3. Disease-free survival (DFS) [ Time Frame: 2 years ]
  4. Progression-free survival (PFS) [ Time Frame: 2 years ]
  5. Overall survival (OS) [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. Have measurable disease per RECIST 1.1 as assessed by the local site investigator and/or radiologist.
  3. Male or female, age≥18 years at the time of informed consent.
  4. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05191667


Locations
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China
Chinese PLA General Hospital
Beijing, China
Sponsors and Collaborators
Adlai Nortye Biopharma Co., Ltd.
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Responsible Party: Adlai Nortye Biopharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT05191667    
Other Study ID Numbers: AN0025S0104
First Posted: January 13, 2022    Key Record Dates
Last Update Posted: January 13, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases