XNW28012 for Pancreatic Cancer

Not yet recruiting at 7 trial locations
YZ
Overseen ByYingyi Zhang
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called XNW28012, a potential drug for metastatic pancreatic cancer, where the cancer has spread to other parts of the body. Researchers are examining two different doses to determine which is most effective. This trial suits those whose pancreatic cancer has worsened despite at least one prior treatment. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Is there any evidence suggesting that XNW28012 is likely to be safe for humans?

Studies have shown that XNW28012 is generally safe. While some side effects might occur, they are usually mild and manageable. Research involving patients with advanced solid tumors, including pancreatic cancer, indicates that XNW28012 is usually well-tolerated. Even patients with extensive prior treatments used this drug without major safety issues. This is promising for prospective trial participants, as it suggests the drug is unlikely to cause serious harm.12345

Why do researchers think this study treatment might be promising?

Most treatments for pancreatic cancer, like chemotherapy and radiation, work by targeting rapidly dividing cells but can also harm healthy cells. XNW28012 stands out because it is designed to target specific cancer cell pathways more precisely, potentially reducing damage to healthy cells. Researchers are particularly excited about its targeted action and the flexible dosing options, with both 2.0 mg/kg and 2.4 mg/kg levels being tested. This targeted approach might lead to fewer side effects and improved outcomes for patients battling this tough-to-treat cancer.

What evidence suggests that XNW28012 might be an effective treatment for pancreatic cancer?

Research has shown that XNW28012 has promising effects against tumors in patients with pancreatic ductal adenocarcinoma, a type of pancreatic cancer. Earlier studies found it safe for patients with advanced solid tumors, even those with extensive prior treatments. For patients with metastatic pancreatic cancer, XNW28012 increased the average survival time to 10.1 months, compared to 7.2 months with other treatments. Additionally, the one-year survival rate improved from 22.3% to 44.1%. These results suggest that XNW28012 could offer significant benefits for those fighting this aggressive cancer. Participants in this trial will receive either a 2.0 mg/kg or 2.4 mg/kg dose of XNW28012 to further evaluate its effectiveness and safety.12456

Are You a Good Fit for This Trial?

This trial is for adults with pancreatic cancer that has spread to other parts of the body (metastatic). Participants should be in generally stable health and able to attend regular clinic visits. People with certain other serious illnesses or conditions may not be eligible.

Inclusion Criteria

Life expectancy of at least 12 weeks
I am not pregnant, as confirmed by a recent test.
I am 18 years old or older.
See 5 more

Exclusion Criteria

I have had lung inflammation or interstitial lung disease before.
I have not received a live vaccine in the past 4 weeks.
I have received G-CSF or GM-CSF support recently before screening.
See 19 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive XNW28012 monotherapy at either 2.0 mg/kg or 2.4 mg/kg, administered intravenously every 3 weeks in 21-day cycles

24 months
Every 3 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and pharmacokinetics

4 weeks

Long-term follow-up

Participants are monitored for progression-free survival and duration of response

24 months

What Are the Treatments Tested in This Trial?

Interventions

  • XNW28012

Trial Overview

The study is testing a new drug called XNW28012, given alone (not combined with other treatments), to see if it is safe and how well it works against metastatic pancreatic cancer. Patients are randomly assigned to different groups.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: XNW28012 2.0 mg/kg dose levelExperimental Treatment1 Intervention
Group II: XNW 28012 2.4 mg/kg dose levelExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Evopoint Biosciences Inc.

Lead Sponsor

Trials
15
Recruited
2,800+

Citations

Evopoint Announced the First Patient Dosed in A Phase III ...

The 5-year survival rate for patients with metastatic pancreatic cancer is only about 3%. XNW28012 demonstrated promising efficacy in patients ...

A Review of Recent Real-World Evidence Data in ...

Pancreatic cancer accounts for 3.2% of all new cancer cases in the United States, and yet it will cause more than twice the rate (7.5%) of all cancer deaths;

Safety, efficacy, and pharmacokinetics of XNW28012, a ...

Conclusions: XNW28012 demonstrated a manageable safety profile in heavily treated advanced solid tumor pts and promising anti-tumor activity in PDAC patients.

NCT06799637 | Study of XNW28012 in Subjects With ...

This is an open-label, dose escalation, multicenter, phase 1, first-in-human study of XNW28012 in subjects with advanced solid tumors who have failed ...

XNW-28012 - Drug Targets, Indications, Patents

A Phase Ib/II clinical study evaluating the safety, tolerability, and efficacy of XNW28012 … treatment of advanced malignant solid tumors. ...

Safety, efficacy, and pharmacokinetics of XNW28012, a ...

XNW28012 demonstrated a manageable safety profile in heavily treated advanced solid tumor pts and promising anti-tumor activity in PDAC ...