AXN-2510 for Cancer

Not currently recruiting at 6 trial locations

Overseen By Jill I Loftiss, RN

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Axion Bio, Inc

Must not be taking: Immune-suppressive medications

Disqualifiers: Brain metastases, Concurrent malignancy, Uncontrolled hypertension, others

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

Compensation: Varies

Number of Visits: 3

Duration: 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called AXN-2510 for individuals with advanced solid tumors that have recurred or do not respond to standard treatments. The trial aims to determine the side effects, optimal dose, and duration of the drug in the body. Participants will receive the treatment via IV every three weeks and will undergo regular checkups. This trial suits those without other standard treatment options who can provide specific tumor information. Participants should not have active brain metastases or be on immune-suppressing medications. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop any prior treatment within 5 half-lives or 4 weeks before starting AXN-2510, whichever is shorter, except for certain hormone therapies for prostate or breast cancer. If you are using immune-suppressive medication, you may need to stop, with some exceptions.

Is there any evidence suggesting that AXN-2510 is likely to be safe for humans?

Earlier studies tested AXN-2510 in people with cancer. These studies showed that the treatment was generally well-tolerated. Some patients experienced side effects, but these were mostly mild or moderate. Importantly, no unexpected safety problems emerged. This early information suggests that AXN-2510 is quite safe for humans, but further research is underway to understand any possible risks. As this trial is in an early stage, it is specifically designed to carefully assess safety and determine the best dose. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard cancer treatments, which often involve chemotherapy targeting rapidly dividing cells, AXN-2510 offers a novel approach by specifically targeting unique cancer cell markers. This targeted mechanism of action minimizes damage to healthy cells, potentially reducing side effects. Moreover, AXN-2510 is administered via intravenous infusion every three weeks, which is less frequent than some current therapies, potentially improving patient convenience and adherence. Researchers are excited about AXN-2510 because it represents a promising new direction in personalized cancer treatment, offering hope for more effective and tolerable options.

What evidence suggests that AXN-2510 might be an effective treatment for cancer?

Research has shown that AXN-2510, the investigational treatment tested in this trial, has promising early results for certain types of non-small cell lung cancer (NSCLC). In studies, 80% of patients with squamous NSCLC and 46% with nonsquamous NSCLC experienced partial tumor shrinkage. Among 17 evaluable patients, about one-third showed some reduction in tumor size. These early findings suggest that AXN-2510 may help reduce tumors in some patients with advanced cancer. However, more research is needed to fully understand its effects on different cancer types. ^{1 2 4 5 6}

Who Is on the Research Team?

Jill I Loftiss, RN

Principal Investigator

Instil Bio

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors who are seeking new treatment options. Participants must be able to attend regular clinic visits and comply with the study procedures.

Inclusion Criteria

Availability of PD-L1 Tumor Proportion Score (TPS) or Combined Positive Score (CPS); OR willingness to submit tumor tissue, if available, for central testing

I am 18 years old or older.

My advanced cancer has not responded to previous treatments and there's no standard therapy left.

Exclusion Criteria

Uncontrolled hypertension defined as blood pressure of ≥ 160 mmHg systolic and/or ≥ 95 mmHg diastolic

Has a history or current evidence of any condition, therapy, or laboratory abnormality that in the opinion of the investigator, might confound the results of the trial

I do not require immediate treatment for brain metastases or leptomeningeal disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AXN-2510 as an intravenous infusion every 3 weeks, with dose escalation based on entry time into the study

24 months

Several visits during the first and third doses, then once every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AXN-2510

Trial Overview

The study tests AXN-2510, a potential cancer medication. It aims to determine side effects, the best tolerated dose, and how long it stays in your body. Patients will receive doses every three weeks and undergo frequent checkups.

How Is the Trial Designed?

Group I: AXN-2510 Experimental Treatment 1 Intervention

AXN-2510 given as intravenous (IV) infusion every 3 weeks, for a maximum of 24 months of treatment or until discontinuation criteria is met. Two increasing dose levels will be tested.

Who Is Running the Clinical Trial?

Axion Bio, Inc

Lead Sponsor

Instil Bio

Industry Sponsor

Trials

3

Recruited

80+

Axion Bio

Collaborator

Citations

1.

targetedonc.com

targetedonc.com/view/imm2510-axn-2510-demonstrates-promising-early-efficacy-in-first-line-nsclc

IMM2510/AXN-2510 Demonstrates Promising Early ...

“'2510 has demonstrated early but compelling activity in frontline NSCLC patients,” said Caicun Zhou, MD, PhD, director of the Department of ...

2.

ir.instilbio.com

ir.instilbio.com/news-releases/news-release-details/immuneonco-announced-preliminary-safety-efficacy-data-clinical

ImmuneOnco Announced Preliminary Safety & Efficacy ...

“'2510 has demonstrated early but compelling activity in front-line NSCLC patients,” said Professor Caicun Zhou, M.D., Ph.D., director of the ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07159828

NCT07159828 | A Study to Assess AXN-2510 Treatment in ...

The goal of this clinical trial is to learn more about the side effects and best dose of AXN-2510 in adults with advanced solid tumors.

4.

cancernetwork.com

cancernetwork.com/view/imm2510-axn-2510-combo-yields-preliminary-responses-in-advanced-nsclc

IMM2510/AXN-2510 Combo Yields Preliminary Responses ...

The treatment combination elicited partial responses in 80% of patients with squamous NSCLC and 46% in nonsquamous NSCLC.

5.

instilbio.gcs-web.com

instilbio.gcs-web.com/news-releases/news-release-details/instil-bio-announces-immuneoncos-presentation-2510-monotherapy

News Release - Investor Relations | Instil Bio

In the 17 efficacy evaluable patients, the objective response rate (“ORR”) was 35.3%, with the majority of responses seen in patients with ...

6.

cn.immuneonco.com

cn.immuneonco.com/news/gsdynamics/584.html

ImmuneOnco Announced Preliminary Safety & Efficacy ...

ImmuneOnco expects to present safety and efficacy data in the IMM2510 chemotherapy combination trial in front-line NSCLC at a future medical conference. The ...