RECRUITING

A Study of ATG-031 in Advanced Solid Tumors or B-cell Non-Hodgkin Lymphomas

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

ATG-031 study (alias: PERFORM) is a multicenter, open-label, Phase 1 study of ATG-031 in patients with advanced solid tumors or B-NHL. The study design includes a Dose Escalation Phase and a Dose Expansion Phase, and will enroll patients with advanced solid tumors (i.e., preferred tumor types) or relapsed/refractory (R/R) B-NHLs. The study's primary objective is to evaluate the safety and tolerability of ATG-031 and determine the RP2D（Refered Phase II dose） of ATG-031.

Official Title

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

Quick Facts

Study Start:2023-12-08

Study Completion:2026-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06028373

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Ashley Liu

CONTACT

0431292256

ting.liu@antengene.com

Ran Wei

CONTACT

13810001510

ran.wei@antengene.com

Study Locations (Sites)

University of California San Francisco (UCSF)

San Francisco, California, 94102

United States

Regents of the University of Colorado

Aurora, Colorado, 80045

United States

Yale University

New Haven, Connecticut, 06520- 8087

United States

University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Antengene Biologics Limited

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-08

Study Completion Date2026-06-30

Study Record Updates

Study Start Date2023-12-08

Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

ATG-031
solid tumor
CD 24

Additional Relevant MeSH Terms

Advanced Solid Tumors
B-cell Non-Hodgkin Lymphomas