Advanced Solid TumorsPhase 1NCT06028373

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

A Phase 1 study testing ATG-031 in people with Advanced Solid Tumors and B-cell Non-Hodgkin Lymphomas, run by Antengene Biologics Limited at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Solid Tumors, B-cell Non-Hodgkin Lymphomas
What is being tested?: ATG-031
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 4 sitesUnited States
Study dates: 8 Dec 2023to 12 Jun 2026
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Histological or cytologically confirmed advanced solid tumor or B-NHL which have relapsed from or been refractory to all locally available standard therapies.
Adequate hepatic function:
AST and ALT ≤ 2.5×times ULN (≤ 5 × ULN if liver metastases).
Total bilirubin ≤ 1.5×ULN (except Gilbert syndrome).
Lipase and amylase ≤ 2×ULN.
Adequate renal function: calculated creatinine clearance of ≥ 40 mL/min using the Cockroft- Gault formula.

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Adequate bone marrow function without growth factors or blood transfusion within 7 days of the first dose of study treatment.
Absolute neutrophil count (ANC) ≥ 1.5×109/L.
Platelet count ≥ 100×109/L.
Hemoglobin ≥ 90 g/L.

Who cannot join

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.
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
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
Other primary malignancies developed within 5 years prior to the first dose of the study treatment
Have active or previous autoimmune diseases that are likely to recur or are at risk of such diseases judged by the investigator.
Major cardiovascular disease

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Active hepatitis B and/or hepatitis C (HBV-DNA or HCV-RNA detectable by local laboratory, respectively).
Patients with history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
A history of allograft organ transplantation for solid tumor or allogeneic hematopoietic stem cell transplantation for B-NHL patients).
Patients who are pregnant or lactating.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Regents of the University of Colorado
Aurora, Colorado, 80045
University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
Yale University
New Haven, Connecticut, 06520- 8087
University of California San Francisco (UCSF)
San Francisco, California, 94102

Other trials in United States

About this study

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

Read the detailed description

This 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. Dose Escalation Phase: approximately 30-48 patients . Dose Expansion Phase: the number of patients enrolled will depend on the number of disease cohorts to be expanded and data observed in the Dose Escalation Phase.The Dose Escalation Phase will enroll patients with advanced solid tumors. Based on data from dose escalation (e.g., adverse events [AEs], dose-limiting toxicity [DLT], efficacy data, pharmacodynamic [PDx] data, or pharmacokinetic [PK] data), the Dose Expansion Phase will enroll patients with selected advanced solid tumors or B-NHL.

Conditions: Advanced Solid Tumors, B-cell Non-Hodgkin Lymphomas
Being tested: ATG-031
Keywords: ATG-031, solid tumor, CD 24

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ATG-031Drug
ATG-031 will be infused Q3W on Day 1 of each cycle, at the starting dose of 0.03 mg/kg and a maximum dose of 9 mg/kg in the Dose Escalation Phase, and the defined MTD if available or OBD in the Dose Expansion Phase. Based on the emerging PK, PDx, safety, and other relevant data, SRC may decide to explore alternative dosing schedules.

Study groups in NCT06028373
Study group	Role	What they receive
ATG-031 dose level 1	Active comparator	Patients with advanced solid tumors or B-cell non-Hodgkin lymphomas will be enrolled in the Dose-Escalation Phase. Dose level is 0.03 mg/kg Receives: Drug: ATG-031
ATG-031 dose level 2	Active comparator	Patients with advanced solid tumors or B-cell non-Hodgkin lymphomas will be enrolled in the Dose-Escalation Phase. Dose level is 0.1 mg/kg Receives: Drug: ATG-031
ATG-031 dose level 3	Active comparator	Patients with advanced solid tumors or B-cell non-Hodgkin lymphomas will be enrolled in the Dose-Escalation Phase. Dose level is 0.3 mg/kg Receives: Drug: ATG-031
ATG-031 dose level 4	Active comparator	Patients with advanced solid tumors or B-cell non-Hodgkin lymphomas will be enrolled in the Dose-Escalation Phase. Dose level is 1.0 mg/kg Receives: Drug: ATG-031
ATG-031 dose level 5	Active comparator	Patients with advanced solid tumors or B-cell non-Hodgkin lymphomas will be enrolled in the Dose-Escalation Phase. Dose level is 2.0 mg/kg Receives: Drug: ATG-031
ATG-031 dose level 6	Active comparator	Patients with advanced solid tumors or B-cell non-Hodgkin lymphomas will be enrolled in the Dose-Escalation Phase. Dose level is 4.0 mg/kg Receives: Drug: ATG-031
ATG-031 dose level 7	Active comparator	Patients with advanced solid tumors or B-cell non-Hodgkin lymphomas will be enrolled in the Dose-Escalation Phase. Dose level is 6.0 mg/kg Receives: Drug: ATG-031
ATG-031 dose level 8	Active comparator	Patients with advanced solid tumors or B-cell non-Hodgkin lymphomas will be enrolled in the Dose-Escalation Phase. Dose level is 9.0 mg/kg Receives: Drug: ATG-031

What is being measured

The primary outcome is the main question the study is designed to answer.

AE
Evaluate the safety and tolerability of ATG-031
Measured: 90 days after last dose of treatment
DLT
Evaluate the safety and tolerability of ATG-031
Measured: at the end of cycle 2 ( each cycle is 21 days)
RP2D
RP2D will be determined based on safety, tolerability, PK, and preliminary efficacy data
Measured: at the end of dose escalation, about 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Dec 202312 Jun 2026

First posted8 Sep 2023
Study start8 Dec 2023
Primary completion8 Apr 2026
Study completion12 Jun 2026

Why it stopped: The study was terminated because of sponsor's development strategy change

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Model description: Dose levels are 0.03 mg/kg、 0.1 mg/kg、0.3 mg/kg 、0.5mg/kg ,or other dose level less than 1.0mg/kg determined by SRC
Masking: None (open label)
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06028373
Sponsor's protocol ID: ATG-031-001
Status last verified: Jul 2026
First submitted: 25 Aug 2023
Last updated: 16 Jul 2026
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A First-in-Human Phase I Study of ATG-031 in Patients With Advanced Solid Tumors or B-cell Non-Hodgkin Lymphomas
ClinicalTrials.gov ID: NCT06028373
Acronym / sponsor ID: ATG-031-001
Conditions: Advanced Solid Tumors, B-cell Non-Hodgkin Lymphomas
Keywords: ATG-031, solid tumor, CD 24
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was terminated because of sponsor's development strategy change
Enrolment: 38 participants (actual)
Lead sponsor: Antengene Biologics LimitedIndustry (pharma, biotech, devices)
Study start: 8 Dec 2023 (actual)
Primary completion: 8 Apr 2026 (actual)
Study completion: 12 Jun 2026 (actual)
First posted: 8 Sep 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 8
Model description: Dose levels are 0.03 mg/kg、 0.1 mg/kg、0.3 mg/kg 、0.5mg/kg ,or other dose level less than 1.0mg/kg determined by SRC

Arm	Type	Receives
ATG-031 dose level 1	Active comparator	Drug: ATG-031Patients with advanced solid tumors or B-cell non-Hodgkin lymphomas will be enrolled in the Dose-Escalation Phase. Dose level is 0.03 mg/kg
ATG-031 dose level 2	Active comparator	Drug: ATG-031Patients with advanced solid tumors or B-cell non-Hodgkin lymphomas will be enrolled in the Dose-Escalation Phase. Dose level is 0.1 mg/kg
ATG-031 dose level 3	Active comparator	Drug: ATG-031Patients with advanced solid tumors or B-cell non-Hodgkin lymphomas will be enrolled in the Dose-Escalation Phase. Dose level is 0.3 mg/kg
ATG-031 dose level 4	Active comparator	Drug: ATG-031Patients with advanced solid tumors or B-cell non-Hodgkin lymphomas will be enrolled in the Dose-Escalation Phase. Dose level is 1.0 mg/kg
ATG-031 dose level 5	Active comparator	Drug: ATG-031Patients with advanced solid tumors or B-cell non-Hodgkin lymphomas will be enrolled in the Dose-Escalation Phase. Dose level is 2.0 mg/kg
ATG-031 dose level 6	Active comparator	Drug: ATG-031Patients with advanced solid tumors or B-cell non-Hodgkin lymphomas will be enrolled in the Dose-Escalation Phase. Dose level is 4.0 mg/kg
ATG-031 dose level 7	Active comparator	Drug: ATG-031Patients with advanced solid tumors or B-cell non-Hodgkin lymphomas will be enrolled in the Dose-Escalation Phase. Dose level is 6.0 mg/kg
ATG-031 dose level 8	Active comparator	Drug: ATG-031Patients with advanced solid tumors or B-cell non-Hodgkin lymphomas will be enrolled in the Dose-Escalation Phase. Dose level is 9.0 mg/kg

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Histological or cytologically confirmed advanced solid tumor or B-NHL which have relapsed from or been refractory to all locally available standard therapies.
Adequate hepatic function:
Adequate renal function: calculated creatinine clearance of ≥ 40 mL/min using the Cockroft- Gault formula.
Adequate bone marrow function without growth factors or blood transfusion within 7 days of the first dose of study treatment.

Key exclusion criteria (10 listed)

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.
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
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
Other primary malignancies developed within 5 years prior to the first dose of the study treatment
Have active or previous autoimmune diseases that are likely to recur or are at risk of such diseases judged by the investigator.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ATG-031ATG-031 will be infused Q3W on Day 1 of each cycle, at the starting dose of 0.03 mg/kg and a maximum dose of 9 mg/kg in the Dose Escalation Phase, and the defined MTD if available or OBD in the Dose Expansion Phase. Based on the emerging PK, PDx, safety, and other relevant data, SRC may decide to explore alternative dosing schedules.	Drug	ATG-031 dose level 1, ATG-031 dose level 2, ATG-031 dose level 3, ATG-031 dose level 4, ATG-031 dose level 5, ATG-031 dose level 6, ATG-031 dose level 7, ATG-031 dose level 8

Primary outcome

AE
Time frame: 90 days after last dose of treatment
Evaluate the safety and tolerability of ATG-031
DLT
Time frame: at the end of cycle 2 ( each cycle is 21 days)
Evaluate the safety and tolerability of ATG-031
RP2D
Time frame: at the end of dose escalation, about 1 year
RP2D will be determined based on safety, tolerability, PK, and preliminary efficacy data

Results and safety

The study was stopped early (reason given: The study was terminated because of sponsor's development strategy change). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.

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Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ATG-031 in people with Advanced Solid Tumors and B-cell Non-Hodgkin Lymphomas, run by Antengene Biologics Limited at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The study was terminated because of sponsor's development strategy change). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AE (time frame: 90 days after last dose of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06028373.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.