Testing ATG-031 in patients with advanced solid tumors or B-cell non-Hodgkin lymphomas

A First-in-Human Phase I Study of ATG-031 in Patients With Advanced Solid Tumors or B-cell Non-Hodgkin Lymphomas

This study is testing a new drug called ATG-031 to see if it is safe and effective for people with advanced solid tumors or certain types of lymphoma.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Antengene Corporation (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 4 sites (San Francisco, California and 3 other locations)
• Trial ID: NCT06028373 on ClinicalTrials.gov

What this trial studies

This multicenter, open-label Phase 1 study evaluates the safety and tolerability of ATG-031 in patients with advanced solid tumors or relapsed/refractory B-cell non-Hodgkin lymphomas. The study consists of a Dose Escalation Phase, enrolling approximately 30-48 patients, followed by a Dose Expansion Phase based on initial findings. The primary goal is to determine the recommended Phase II dose (RP2D) of ATG-031, using data on adverse events, dose-limiting toxicity, and efficacy. Patients will be monitored closely throughout the trial to assess the drug's effects.

Who should consider this trial

Good fit: Ideal candidates include individuals with histologically confirmed advanced solid tumors or B-cell non-Hodgkin lymphomas that are relapsed or refractory to standard treatments.

Not a fit: Patients with central nervous system malignancies or those who have received other investigational products 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 or B-cell non-Hodgkin lymphomas that have not responded to existing therapies.

How similar studies have performed: While this approach is novel, similar studies targeting advanced solid tumors and B-cell non-Hodgkin lymphomas have shown promise in the past.

Eligibility criteria

Key Inclusion Criteria:

1. Histological or cytologically confirmed advanced solid tumor or B-NHL which have relapsed from or been refractory to all locally available standard therapies.
2. Adequate hepatic function:

   1. AST and ALT ≤ 2.5×times ULN (≤ 5 × ULN if liver metastases).
   2. Total bilirubin ≤ 1.5×ULN (except Gilbert syndrome).
   3. Lipase and amylase ≤ 2×ULN.
3. Adequate renal function: calculated creatinine clearance of ≥ 40 mL/min using the Cockroft- Gault formula.
4. Adequate bone marrow function without growth factors or blood transfusion within 7 days of the first dose of study treatment.

   1. Absolute neutrophil count (ANC) ≥ 1.5×109/L.
   2. Platelet count ≥ 100×109/L.
   3. Hemoglobin ≥ 90 g/L.

Key Exclusion Criteria:

1. Patients with CNS malignancies, except those who are clinically stable for ≥ 4 weeks and off corticosteroids following prior surgery, whole-brain radiation, or stereotactic radiosurgery.
2. Received any other investigational product or prior systemic anticancer therapy including chemotherapy, immunotherapy, radiotherapy, or other anticancer within 21 days prior to first dose of study
3. Grade ≥3 irAEs or irAEs that lead to discontinuation of prior immunotherapy.8. Other primary malignancies developed within 5 years prior to the first dose of the study treatment
4. Other primary malignancies developed within 5 years prior to the first dose of the study treatment
5. Have active or previous autoimmune diseases that are likely to recur or are at risk of such diseases judged by the investigator.
6. Major cardiovascular disease
7. Active hepatitis B and/or hepatitis C (HBV-DNA or HCV-RNA detectable by local laboratory, respectively).
8. Patients with history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
9. A history of allograft organ transplantation for solid tumor or allogeneic hematopoietic stem cell transplantation for B-NHL patients).
10. Patients who are pregnant or lactating.

Where this trial is running

San Francisco, California and 3 other locations

• University of California San Francisco (UCSF) — San Francisco, California, United States (Recruiting)
• Regents of the University of Colorado — Aurora, Colorado, United States (Recruiting)
• Yale University — New Haven, Connecticut, United States (Recruiting)
• University of Texas M.D. Anderson Cancer Center — Houston, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Ashley Liu

Conditions Advanced Solid Tumors; B-cell Non-Hodgkin Lymphomas; ATG-031; solid tumor; CD 24