Esophageal CancerPhase 1NCT05191667
AN0025 and Chemoradiotherapy Combination in Esophageal Cancer
A Phase 1 study testing AN0025 in people with Esophageal Cancer, run by Adlai Nortye Biopharma Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- AN0025
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 18 Jan 2022to Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Multicenter Phase Ib Study of AN0025 in Combination With Chemoradiotherapy in Patients With Locally Advanced/Locally Recurrent Esophageal Cancer
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.
Read the 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.
- Conditions
- Esophageal Cancer
- Being tested
- AN0025
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AN0025Drug
Also called Paclitaxel, Carboplatin, Radiotherapy
250 mg or 500 mg Q.D., oral administration
| Study group | Role | What they receive |
|---|---|---|
| Patients with unresectable locally advanced/locally recurrent esophageal cancer | Experimental | Patients will receive AN0025 orally once daily (QD) and chemoradiotherapy followed by the maintenance of AN0025 Receives: Drug: AN0025 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 4 weeks
Secondary outcomes (5)
Complete response rate (CRR)
The rate of patients with complete response in all tumor evaluable patients
Measured: 2 years
Objective response rate (ORR)
The rate of patients with complete response and partial response in all tumor evaluable patients
Measured: 2 years
Disease control rate (DCR)
The rate of patients with complete response, partial response and stable disease in all tumor evaluable patients
Measured: 2 years
Progression-free survival (PFS)
The duration from the date of 1st dose to imageological progression or death, which earlier
Measured: 2 years
Overall survival (OS)
The duration from the date of 1st dose to death
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start18 Jan 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: The study is not stopped but the enrollment is suspended until a further decision from sponsor.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adlai Nortye Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianming Xu, MD, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05191667
- Sponsor's protocol ID
- AN0025S0104
- Status last verified
- Feb 2025
- First submitted
- 26 Dec 2021
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Multicenter Phase Ib Study of AN0025 in Combination With Chemoradiotherapy in Patients With Locally Advanced/Locally Recurrent Esophageal Cancer
- ClinicalTrials.gov ID
- NCT05191667
- Acronym / sponsor ID
- AN0025S0104
- Conditions
- Esophageal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The study is not stopped but the enrollment is suspended until a further decision from sponsor.
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Adlai Nortye Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 13 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with unresectable locally advanced/locally recurrent esophageal cancer | Experimental | Drug: AN0025Patients will receive AN0025 orally once daily (QD) and chemoradiotherapy followed by the maintenance of AN0025 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AN0025Also: Paclitaxel, Carboplatin, Radiotherapy250 mg or 500 mg Q.D., oral administration | Drug | Patients with unresectable locally advanced/locally recurrent esophageal cancer |
Primary outcome
Number of participants with Dose Limiting Toxicities (DLTs)
Time frame: 4 weeks
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)
5 secondary outcomes
Complete response rate (CRR)
Time frame: 2 years
Objective response rate (ORR)
Time frame: 2 years
Disease control rate (DCR)
Time frame: 2 years
Progression-free survival (PFS)
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianming Xu, MD principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AN0025 in people with Esophageal Cancer, run by Adlai Nortye Biopharma Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Dose Limiting Toxicities (DLTs) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.