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RecruitingLast updated: 2 October 2023

CLINCH: This study seeks to determine the recommended dose level of a new drug (called ATG-022) in people with advanced solid cancersAn Open, Multi-center, Phase I Clinical Study of ATG 022 in Patients With Advanced/Metastatic Solid Tumors

Clinical summary

Summary

This study has two stages. 

In the first stage (Dose Escalation), participants will be assigned to cohorts that will receive escalating doses of the study drug (called ATG-022). ATG-022 will be  given once every three weeks regardless of which dose is being given.

In the second stage (Dose Expansion), participants will receive ATG-022 at the dose level determined as safe and tolerable in the first stage. The aim of the second stage is to further evaluate the safety, tolerability and efficacy of ATG-022.

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

Trial Acronym

CLINCH

More information

Trial Identifiers

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Trial sponsor

Antengene Biologics Limited

Scientific Title

An Open, Multi-center, Phase I Clinical Study of ATG 022 in Patients With Advanced/Metastatic Solid Tumors

Eligibility

Inclusion

  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

  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.

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has not spread to other parts of the body.
  • but it is not possible to perform surgery to remove it.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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