What is ATG-022 studying for advanced or metastatic solid tumors?

ATG-022 is being studied to find the best dose and to evaluate its safety and effects in patients with advanced or metastatic solid tumors. This Phase I trial by Antengene Biologics Limited focuses on patients whose tumors have progressed despite standard treatments or who are not eligible for such treatments. The trial aims to explore how ATG-022 works in these difficult-to-treat tumors.

Who may be eligible for this advanced or metastatic solid tumor clinical trial?

Adults aged 18 years or older with advanced or metastatic solid tumors that have progressed or are intolerant to standard therapies may be eligible. Both men and women can participate, but women must not be pregnant or breastfeeding and must use contraception if of childbearing potential. Participants should have measurable tumors and be willing to provide biopsy samples if needed. Please review eligibility criteria for more details.

Is there any cost to participate in this advanced or metastatic solid tumor clinical trial?

Study-related care, including the study drug ATG-022 and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for these potential costs.

Actively Recruiting

Phase 1

Age: 18Years +

All Genders

ID05718895

Phase I Study of ATG-022 for Adults With Advanced or Metastatic Solid Tumors

Led by Antengene Biologics Limited · Updated on 2026-04-15

156

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating ATG-022 in patients with advanced or metastatic solid tumors in this Phase I, multi-center, open-label clinical trial. The study aims to find the best dose of ATG-022 and to assess its safety and how well it is tolerated. The trial includes patients whose tumors have progressed despite standard treatments or who cannot undergo standard therapies, with a focus on solid tumors and those expressing Claudin 18.2 in the Dose Expansion Phase. The study consists of two main parts a Dose Escalation Phase and a Dose Expansion Phase. In the Dose Escalation Phase, patients receive ATG-022 in cycles of 21 days, starting with a low dose of 0.3 mgkg every three weeks, increasing through defined dose levels to find the maximum tolerated dose. The Dose Expansion Phase enrolls up to 120 patients with Claudin 18.2-positive tumors at the recommended dose to further evaluate safety and efficacy. Participants will undergo biopsies if recent tumor samples are unavailable and must have measurable tumors per RECIST v1.1 criteria. Researchers will monitor side effects and dose-limiting toxicities within 21 days and assess progression-free survival, overall response rate, and duration of response up to 12 months after the last patient is enrolled. Women of childbearing potential and men must use contraception during and after the study. The total participation time varies depending on treatment and follow-up schedules.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling, and analyses.
Aged at least 18 years as of the date of consent.
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).
Dose Escalation Phase: all solid tumors.
Dose Expansion Phase: Claudin 18.2 positive solid tumors.
Willingness to receive a biopsy at screening if no tumor tissue samples within 36 months are available.
At least 1 measurable lesion per RECIST v1.1.
Estimated life expectancy of a minimum of 12 weeks.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Females should use adequate contraception until 180 days after treatment ends, not be breastfeeding, and have a negative pregnancy test if of child-bearing potential.
Male subjects should use effective contraception during the study and for 180 days after the final dose.

You will not qualify if you...

Primary central nervous system disease or central nervous system metastatic disease.
Prior exposure to a Claudin 18.2 targeting agent.
Prior chemotherapy, immunotherapy, anticancer agents, or investigational products within 28 days before the first study dose or until cleared from the body.
Prior vaccination within 28 days of the first dose of study therapy.
Prior solid organ transplant.
Autologous stem cell transplant or CAR-T cell infusion less than 6 months before the first dose.
Active infection including hepatitis B or C.
Known history of HIV infection.
Unresolved toxicities from prior therapy greater than Grade 1, except alopecia.
Pregnant or nursing females.
History of allergic reactions to drugs similar to ATG-022.
Other primary malignancies within 5 years before first study dose, except locally curable malignancies after radical treatment.
Conditions or complications that may affect study compliance or suitability as judged by the investigator.

Research Team

Felix Li

Sunny He

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Phase I Study of ATG-022 for Adults With Advanced or Metastatic Solid Tumors

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria