ATG-031 for Cancer

Recruiting at 3 trial locations

Overseen By Ran Wei

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Antengene Biologics Limited

Must not be taking: Corticosteroids, Chemotherapy, Immunotherapy, others

Disqualifiers: CNS malignancies, Autoimmune diseases, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety of a new treatment called ATG-031, an experimental therapy for individuals with advanced solid tumors or B-cell non-Hodgkin lymphomas, a type of blood cancer. Researchers are exploring different doses to determine the safest and most effective amount for future studies. Individuals with advanced solid tumors or recurrent B-cell non-Hodgkin lymphomas after treatment may qualify for this trial. Participants should have good liver and kidney function and have already tried standard available therapies. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that you should not have received any other investigational product or prior systemic anticancer therapy within 21 days before the first dose of the study treatment.

Is there any evidence suggesting that ATG-031 is likely to be safe for humans?

Research shows that ATG-031 is being tested for safety in individuals with advanced solid tumors or B-cell non-Hodgkin lymphomas. This marks the first human trial of this treatment. The primary goal is to assess its safety and tolerability.

As an early-stage study, detailed safety information in humans may be limited. The study gradually increases the dose to determine the safest and most effective amount, starting with a low dose and increasing it step by step while monitoring for side effects or reactions.

In these early trials, side effects may occur, but the team closely monitors participants. If ATG-031 proves safe and well-tolerated at various doses, it could advance to more extensive testing. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about ATG-031 because it offers a novel approach to treating advanced solid tumors and B-cell non-Hodgkin lymphomas. Unlike traditional therapies that typically target the cancer cells directly, ATG-031 leverages a new mechanism of action that could potentially enhance the body's immune response against these cancers. This innovative strategy might improve outcomes for patients who have not responded well to existing treatments like chemotherapy or targeted therapies. The dose-escalation approach in this trial aims to find the most effective and safe dosage, optimizing the potential benefits of ATG-031.

What evidence suggests that ATG-031 might be an effective treatment for cancer?

Research has shown that ATG-031 is a new treatment tested in this trial. It targets a protein called CD24, found on some cancer cells, which may help these cells evade the immune system. Early results suggest ATG-031 might enable the immune system to identify and attack these cancer cells. In this trial, researchers are testing ATG-031 at various dose levels in patients with advanced solid tumors and B-cell non-Hodgkin lymphomas, which are difficult-to-treat cancers. Although human studies have provided limited information, this approach offers a promising new way to combat these cancers. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors or B-cell Non-Hodgkin Lymphomas that have not responded to standard treatments. Participants must have good kidney function, adequate blood counts without recent transfusions, and stable enzyme levels indicating proper liver function.

Inclusion Criteria

My blood counts meet the required levels without needing transfusions or growth factors recently.

My liver functions are within the required limits.

My cancer has not responded to standard treatments.

Exclusion Criteria

I have not had any other cancer types in the last 5 years.

Active hepatitis B and/or hepatitis C (HBV-DNA or HCV-RNA detectable by local laboratory, respectively)

I have a significant heart condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of ATG-031 to evaluate safety and determine the RP2D

Approximately 1 year

Multiple visits as per dose escalation protocol

Dose Expansion

Participants receive the determined RP2D of ATG-031 to further evaluate safety and efficacy

Duration depends on cohort expansion

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

What Are the Treatments Tested in This Trial?

Interventions

• ATG-031

Trial Overview The PERFORM study is testing a new medication called ATG-031 in two phases: first to find the safest dose (Dose Escalation Phase) and then to see how well it works at that dose (Dose Expansion Phase).

How Is the Trial Designed?

Group I: ATG-031 dose level 1 Active Control 1 Intervention

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

Group II: ATG-031 dose level 5 Active Control 1 Intervention

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

Group III: ATG-031 dose level 6 Active Control 1 Intervention

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

Group IV: ATG-031 dose level 4 Active Control 1 Intervention

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

Group V: ATG-031 dose level 2 Active Control 1 Intervention

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

Group VI: ATG-031 dose level 7 Active Control 1 Intervention

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

Group VII: ATG-031 dose level 8 Active Control 1 Intervention

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

Group VIII: ATG-031 dose level 3 Active Control 1 Intervention

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

ATG-031 is already approved in United States for the following indications:

Approved in United States as ATG-031 for:

Who Is Running the Clinical Trial?

Antengene Biologics Limited

Lead Sponsor

Trials

3

Recruited

240+

Published Research Related to This Trial

CHI3L1 is a protein involved in various biological processes such as inflammation, tissue repair, and cancer progression, and is linked to several diseases including asthma, arthritis, and various cancers.

Targeted therapies based on CHI3L1 are being explored for treating tumors like glioma and colon cancer, highlighting its potential as a therapeutic target in oncology and autoimmune diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chitinase-3 like-protein-1 function and its role in diseases. Zhao, T., Su, Z., Li, Y., et al.[2021]

The combination of atezolizumab, a PD-L1 inhibitor, with platinum-based chemotherapy significantly improves overall survival in patients with extensive-stage small cell lung cancer compared to chemotherapy alone.

This research suggests that this combination therapy could become a new first-line treatment option for patients suffering from this aggressive form of lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study: Atezolizumab Improves Survival in SCLC. [2019]

The phase 3 KEYNOTE-522 trial demonstrated that adding pembrolizumab, a PD-1 axis blocker, to chemotherapy significantly improves pathological complete response rates in patients with advanced triple-negative breast cancer, regardless of their PD-L1 status.

This combination therapy not only enhances treatment effectiveness but also appears to improve overall survival rates for patients with this aggressive form of breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expanding the Role for Immunotherapy in Triple-Negative Breast Cancer. Savas, P., Loi, S.[2020]

In a study of 154 patients with oesophageal adenocarcinoma (OAC) and squamous cell carcinoma (SCC), high levels of activated STAT3 (pSTAT3) were linked to worse survival outcomes in SCC, while higher pSTAT3 levels in OAC were associated with better survival, indicating a complex role of STAT3 in different cancer types.

Treatment with the STAT3 inhibitor STATTIC in cancer cell lines led to reduced survival, proliferation, and migration, along with increased apoptosis, suggesting that targeting STAT3 could be a promising therapeutic strategy for both OAC and SCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

pSTAT3 Levels Have Divergent Expression Patterns and Associations with Survival in Squamous Cell Carcinoma and Adenocarcinoma of the Oesophagus. O' Sullivan, KE., Michielsen, AJ., O' Regan, E., et al.[2018]

Pentraxin 3 (PTX3) is found to be abnormally expressed in most types of cancer and is significantly linked to patient prognosis and tumor stage, suggesting its potential as a pan-cancer prognostic biomarker.

In kidney renal clear cell carcinoma (KIRC), PTX3 not only serves as an independent prognostic factor but also blocking its expression can inhibit cancer cell growth and invasion, highlighting its role in tumor progression and potential therapeutic target.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pan-Cancer Analysis of Pentraxin 3: A Potential Biomarker of COVID-19. Zhou, Z., Zhou, X., Yang, Y., et al.[2022]

C3AR1 mRNA is identified as a potential therapeutic target in osteosarcoma, with low expression levels correlating with worse patient outcomes and a higher likelihood of metastasis.

Overexpressing C3AR1 in osteosarcoma cells led to reduced cell proliferation, migration, and invasion, while promoting apoptosis, suggesting its role in regulating tumor behavior and the tumor microenvironment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

C3AR1 mRNA as a Potential Therapeutic Target Associates With Clinical Outcomes and Tumor Microenvironment in Osteosarcoma. Zou, T., Liu, W., Wang, Z., et al.[2021]

The combination of the PD-L1 inhibitor atezolizumab with standard chemotherapy significantly improves overall survival in patients with metastatic triple-negative breast cancer compared to chemotherapy alone.

This research suggests that adding atezolizumab could provide a new treatment option for patients suffering from this aggressive form of breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PD-L1 Inhibitor Improves Survival in TNBC. [2019]

High expression of CX3CL1 in breast carcinoma is associated with increased levels of immune cells (CD8+ T cells, NK cells, and dendritic cells) and correlates with significantly better disease-free and overall survival rates in patients.

CX3CL1 has been identified as an independent prognostic factor for breast cancer outcomes, suggesting it could serve as a new biomarker and a potential target for developing more effective treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High expression of CX3CL1 by tumor cells correlates with a good prognosis and increased tumor-infiltrating CD8+ T cells, natural killer cells, and dendritic cells in breast carcinoma. Park, MH., Lee, JS., Yoon, JH.[2022]

CX3CL1 is differentially expressed across various cancer types and is associated with clinical characteristics and tumor stages, indicating its potential role in tumor progression and malignancy.

High levels of CX3CL1 expression correlate with varying patient outcomes depending on the cancer type, and it is linked to immune cell presence in the tumor microenvironment, suggesting it could be a target for immunotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic pan-cancer analysis reveals the clinical prognosis and immunotherapy value of C-X3-C motif ligand 1 (CX3CL1). Sun, Y.[2023]

In a study involving 727 clear cell renal cell carcinoma (ccRCC) patients, low expression of STAT3 and high expression of SCGN were associated with better prognosis, suggesting these markers could help predict patient outcomes.

The research indicates that high STAT3 expression may lead to resistance against sunitinib treatment, highlighting the importance of STAT3 immunohistochemistry in guiding non-operative treatment strategies for ccRCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SCGN and STAT3 expressions are associated with the prognosis of ccRCC. Lai, C., Gong, J., Tang, J., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06028373

A Study of ATG-031 in Advanced Solid Tumors or B-cell ... 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.

2. clin.larvol.com clin.larvol.com/trial-detail/NCT06028373

A Study of ATG-031 in Advanced Solid Tumors or B-cell ... The Phase I PERFORM study is designed to evaluate the safety and preliminary efficacy of ATG-031 in patients with advanced solid tumors or B-cell non-Hodgkin's ...

3. antengene.com antengene.com/newsinfo/375

Antengene Announces the Study of Anti-CD24 Monoclonal ... The PERFORM trial is a first-in-human, multi-center, open-label, Phase I dose-finding study of ATG-031 in patients with advanced solid tumors or ...

4. prnewswire.com prnewswire.com/apac/news-releases/antengene-announces-the-study-of-anti-cd24-monoclonal-antibody-atg-031-dosed-its-first-patient-in-the-united-states-302010807.html

Antengene Announces the Study of Anti-CD24 Monoclonal ... The PERFORM trial is a first-in-human, multi-center, open-label, Phase I dose-finding study of ATG-031 in patients with advanced solid tumors or ...

5. firstwordpharma.com firstwordpharma.com/story/5796510

Antengene Presents Results from Five Investigational ... It has presented results from five programs by poster presentation, including two clinical programs on the anti-CD24 monoclonal antibody ATG-031 and the PD-L1/ ...

6. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.TPS2691

A first-in-human phase I study of ATG-031, anti-CD24 ... Methods: ATG-031 is undergoing evaluation for safety and preliminary antitumor efficacy in a Phase I, multi-center, open-label clinical study, ...

7. mdanderson.org mdanderson.org/patients-family/diagnosis-treatment/clinical-trials/clinical-trials-index/clinical-trials-detail.ID2023-0515.html

A first-in-human phase 1 study of ATG-031 in patients with ... 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. Resources and ...