Testing ATG-022 for advanced solid tumors

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

This study is testing a new treatment called ATG-022 to see if it is safe and effective for people with advanced solid tumors.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 156 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Antengene Corporation (industry)
• Drugs / interventions: CAR-T, chemotherapy, immunotherapy
• Locations: 22 sites (Adelaide and 21 other locations)
• Trial ID: NCT05718895 on ClinicalTrials.gov

What this trial studies

This is a Phase I, multi-center, open-label clinical study designed to evaluate the safety, tolerability, and efficacy of ATG-022 in patients with advanced or metastatic solid tumors. The study includes a Dose Escalation Phase for all solid tumors and a Dose Expansion Phase specifically for tumors expressing Claudin 18.2 at the maximum tolerated dose. Participants will undergo assessments to determine the appropriate dosage and monitor responses to the treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with advanced or metastatic solid tumors that have progressed despite standard treatments.

Not a fit: Patients with early-stage tumors or those who have not yet undergone standard therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that have not responded to standard therapies.

How similar studies have performed: While this approach is novel in its specific targeting of Claudin 18.2, similar studies have shown promise in treating advanced solid tumors with targeted therapies.

Eligibility 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.

Where this trial is running

Adelaide and 21 other locations

• Cancer Research SA Pty Ltd — Adelaide, Australia (COMPLETED)
• Cabrini Health Limited — Malvern, Australia (RECRUITING)
• Integrated Clinical Oncology Network Pty Ltd (Icon) — South Brisbane, Australia (RECRUITING)
• Beijing GoBroad Hospital — Beijing, China (RECRUITING)
• West China Hospital, Sichuan University — Chengdu, China (RECRUITING)
• Fujian Cancer Hospital — Fuzhou, China (RECRUITING)
• Anhui Provincial Hospital — Hefei, China (RECRUITING)
• The First Affiliated Hospital of Anhui Medical University — Hefei, China (RECRUITING)
• Jinan Central Hospital — Jinan, China (RECRUITING)
• Gansu provincial cancer hospital [recruiting] — Lanzhou, China (RECRUITING)
• The Affiliated Hospital of Qingdao University — Qingdao, China (RECRUITING)
• Fudan University Shanghai Cancer Center — Shanghai, China (RECRUITING)
• Tongren Hospital Shanghai — Shanghai, China (RECRUITING)
• Liaoning Cancer Hospital — Shenyang, China (RECRUITING)
• The Fourth Hospital of Hebei Medical University — Shijiangzhuang, China (RECRUITING)
• Shanxi provincial cancer hospital — Taiyuan, China (RECRUITING)
• Tianjin Medical Universuty Cancer Institute & Hospital — Tianjin, China (RECRUITING)
• Hubei Cancer Hospital — Wuhan, China (RECRUITING)
• The First affiliated hospital of Xi'An Jiao Tong Ubiversity — Xi'an, China (RECRUITING)
• Xuzhou Central Hospital — Xuzhou, China (RECRUITING)
• General Hospital of Ningxia Medical University — Yinchuan, China (RECRUITING)
• The First Affiliated Hospital of Zhenghzou University — Zhengzhou, China (RECRUITING)

Study contacts

• Study coordinator: Felix Li

Conditions: Advanced/Metastatic Solid Tumors