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A Study of ATG-022 in Patients With Advanced/Metastatic Solid Tumors (CLINCH)

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: NCT05718895
Recruitment Status : Recruiting
First Posted : February 8, 2023
Last Update Posted : April 10, 2024
Sponsor:
Information provided by (Responsible Party):
Antengene Corporation ( Antengene Biologics Limited )

Study Description
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Brief Summary:
This is an Open, Multi-center, Phase I Clinical Study of ATG 022 in Patients with Advanced/metastatic Solid Tumors

Condition or disease Intervention/treatment Phase
Advanced/Metastatic Solid Tumors Drug: ATG-022 Phase 1

Detailed Description:
This is a Phase I, multi-center, open-label, dose-finding study of ATG-022 in patients with advanced solid tumours. The study design includes a Dose Escalation Phase which will enroll subjects with advanced/metastatic solid tumors, and a Dose Expansion Phase which will enroll select advanced/metastatic solid tumors with Claudin 18.2-positive expression at the defined maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) to further evaluate the safety, tolerability, and efficacy of ATG-022.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Intervention Model Description: A treatment cycle of ATG-022 will be defined as 21 days. Dosing will begin at 0.3 mg/kg Q3W with 1 subject
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open, Multi-center, Phase I Clinical Study of ATG 022 in Patients With Advanced/Metastatic Solid Tumors
Actual Study Start Date : March 27, 2023
Estimated Primary Completion Date : June 30, 2026
Estimated Study Completion Date : June 30, 2026
Arms and Interventions
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Arm Intervention/treatment
Experimental: ATG-022

Dose Escalation Phase:

for subjects with solid tumors,approximately 16-36 subjects will be enrolled .

Dose Expansion Phase:

The tumor types in the Dose Expansion Phase may involve other tumor types based on the signals from the Dose Escalation Phase. The total number of patients in dose expansion will be up to approximately 120 patients.

 Drug: ATG-022

Dose Escalation Phase:

A treatment cycle of ATG-022 will be defined as 21 days. Dosing will begin at 0.3 mg/kg once every 3 weeks (Q3W) with 1 subject ,the following dose cohorts (0.9, 1.8, 2.4, 3.0, and 3.6 mg/kg Q3W) will require at least 3 and up to 6 evaluable subjects by using dose escalation plan of "3+3" design.


Outcome Measures
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Primary Outcome Measures :
  1. DLT [ Time Frame: Up to 21 Days ]
    Number of Participants with Dose Limiting Toxicity

  2. MTD [ Time Frame: Up to 21 Days ]
    Maximum Tolerated Dose

  3. RP2D [ Time Frame: Up to 21 Days ]
    RP2D= Recommended Phase 2 Dose


Secondary Outcome Measures :
  1. PFS [ Time Frame: 12 months after the last subject enrolled ]
    Progression Free Survival

  2. ORR [ Time Frame: 12 months after the last subject enrolled ]
    Overall Response Rate

  3. DOR [ Time Frame: 12 months after the last subject enrolled ]
    Duration of Response


Other Outcome Measures:
  1. OS [ Time Frame: 12 months after the last subject enrolled ]
    Overall Survival


Eligibility Criteria
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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. Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling, and analyses.
  2. Aged at least 18 years as of the date of consent.

  3. Histological or cytological confirmation of a solid tumor, and have progressed despite standard therapy(ies), or are intolerant to standard therapy(ies), or not applicable for standard therapy(ies).

    1. Dose Escalation Phase: all solid tumors.
    2. Dose Expansion Phase: Claudin 18.2 positive solid tumors.
  4. Subjects should be willing to receive a biopsy at screening, if no former available tumor tissue samples within 36 months prior to participating in the study are provided.
  5. At least 1 measurable lesion per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
  6. Estimated life expectancy of a minimum of 12 weeks.
  7. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 .
  8. Females should be using adequate contraceptive measures until 180 days after the end of treatment, should not be breastfeeding, and must have a negative pregnancy test prior to the start of dosing if of child-bearing potential or must have evidence of nonchild-bearing potential by fulfilling one of the following criteria at screening
  9. Male subjects should be willing to use effective contraception, ie condoms, for the duration of the study and 180 days after the final dose of study treatment.

Exclusion Criteria:

  1. Primary central nervous system disease or central nervous system metastatic disease.
  2. Prior exposure to a Claudin 18.2 targeting agent.
  3. Prior therapy with any chemotherapy, immunotherapy, anticancer agents, or investigational products from a previous clinical study within 28 days of the first dose of study treatment or within a period during which the investigational product or systemic anticancer treatment has not been cleared from the body (eg, a period of 5 'half-lives'.
  4. Prior vaccination within 28 days of the first dose of study therapy.
  5. Prior any solid organ transplant. Autologous stem cell transplant or CAR-T cell infusion < 6 months prior to the first dose of study treatment.
  6. Active infection including hepatitis B, and/or hepatitis C.
  7. Known history of human immunodeficiency virus (HIV) infection.
  8. Any unresolved toxicities from prior therapy greater than Grade 1 at the time of ICF signature, with the exception of alopecia.
  9. Pregnant or nursing females.
  10. History of hypersensitivity or history of allergic reactions attributed to drugs with a similar chemical or biologic structure or class to ATG-022.
  11. Other primary malignancies developed within 5 years prior to the first dose of the study drug, except locally curable malignancies after radical treatment .
  12. In the opinion of the investigator, subject's complications, or other conditions (psychological, familial, sociological, or geographical etc.) may affect protocol compliance or may be unsuitable for participation in the study.
Contacts and Locations
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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): NCT05718895


Contacts
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Contact: Huifen Zheng 18620667595 huifen.zheng@antengene.com
Contact: Sunny He sunny.he@antengene.com

Locations
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Australia
Cancer Research SA Pty Ltd Recruiting
Adelaide, Australia
Contact: Kelly Kelly Mead       kmead@cancerresearchsa.com.au   
Principal Investigator: SARWAN BISHNOI, Doctorate         
Cabrini Health Limited Recruiting
Malvern, Australia
Contact: Deb Macdonald       researchgovernance@cabrini.com.au   
Principal Investigator: SHEHARA MENDIS, MD         
Integrated Clinical Oncology Network Pty Ltd (Icon) Recruiting
South Brisbane, Australia
Contact: Senior Operations Manager       CFRemittances@Icon.team   
Principal Investigator: Jermaine COWARD         
China
West China Hospital, Sichuan University Recruiting
Chengdu, China
Contact: Li Zheng, MD       18980601950@163.com   
Principal Investigator: Li Zheng, MD         
Principal Investigator: Dan Cao, MD         
Gansu provincial cancer hospital [recruiting] Recruiting
Lanzhou, China
Contact: Yuhua Liu, MD       tianlujyx@163.com   
Principal Investigator: Yuhua Liu, MD         
The Affiliated Hospital of Qingdao University Not yet recruiting
Qingdao, China
Contact: Jing Lv, MD       qdfy82912773@126.com   
Principal Investigator: Jing Lv, MD         
Tongren Hospital Shanghai Recruiting
Shanghai, China
Contact: Jianjun Zhang, MD       robustzhang168@aliyun.com   
Principal Investigator: Jianjun Zhang, MD         
Liaoning Cancer Hospital Recruiting
Shenyang, China
Contact: Jingdong Zhang, MD       jdzhang@cancerhosp-ln-cmu.com   
Principal Investigator: Jingdong Zhang, MD         
The Fourth Hospital of Hebei Medical University Recruiting
Shijiangzhuang, China
Contact: Qun Zhao, MD       zhaoqun516@126.com   
Principal Investigator: Qun Zhao, MD         
Shanxi provincial cancer hospital Recruiting
Taiyuan, China
Contact: Jinfeng Ma, MD       mjinfeng99@163.com   
Principal Investigator: Jinfeng Ma, MD         
Hubei Cancer Hospital Recruiting
Wuhan, China
Contact: Xinjun Liang, MD       459992533@qq.com   
Principal Investigator: Xinjun Liang, MD         
Sponsors and Collaborators
Antengene Biologics Limited
More Information
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Responsible Party: Antengene Biologics Limited
ClinicalTrials.gov Identifier: NCT05718895    
Other Study ID Numbers: ATG-022-ST-001
First Posted: February 8, 2023    Key Record Dates
Last Update Posted: April 10, 2024
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms