Actively Recruiting
A Study of ATG-031 in Advanced Solid Tumors or B-cell Non-Hodgkin Lymphomas
Led by Antengene Biologics Limited · Updated on 2025-06-09
80
Participants Needed
4
Research Sites
185 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of ATG-031 in Advanced Solid Tumors or B-cell Non-Hodgkin Lymphomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed advanced solid tumor or B-NHL relapsed or refractory to all standard therapies
- AST and ALT less than or equal to 2.5 times the upper limit of normal (ULN), or up to 5 times ULN if liver metastases are present
- Total bilirubin less than or equal to 1.5 times ULN, except for Gilbert syndrome
- Lipase and amylase less than or equal to 2 times ULN
- Creatinine clearance of at least 40 mL/min calculated by Cockroft-Gault formula
- Adequate bone marrow function without growth factors or blood transfusion within 7 days before first dose
- Absolute neutrophil count at least 1.5 x 10^9/L
- Platelet count at least 100 x 10^9/L
- Hemoglobin at least 90 g/L
You will not qualify if you...
- Patients with central nervous system malignancies unless clinically stable for at least 4 weeks and off corticosteroids after prior treatments
- Received any investigational or systemic anticancer therapy within 21 days before first dose
- Grade 3 or higher immune-related adverse events or those leading to stopping prior immunotherapy
- Other primary cancers developed within 5 years prior to first dose
- Active or previous autoimmune diseases likely to recur or judged at risk by investigator
- Major cardiovascular diseases
- Active hepatitis B or C infection (detectable viral DNA or RNA)
- History of HIV infection or AIDS
- History of solid organ or allogeneic stem cell transplantation
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
University of California San Francisco (UCSF)
San Francisco, California, United States, 94102
Actively Recruiting
2
Regents of the University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
3
Yale University
New Haven, Connecticut, United States, 06520- 8087
Actively Recruiting
4
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Ashley Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
8
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