ASP2138 for Pancreatic Cancer

Recruiting at 1 trial location

Overseen By Astellas Pharma Global Development, Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Astellas Pharma Global Development, Inc.

Must not be taking: Immunosuppressants, Warfarin

Disqualifiers: Cardiac disease, Autoimmune disease, Others

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

Compensation: Varies

Number of Visits: Unknown

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new treatment called ASP2138 for surgically removable pancreatic ductal cancer. ASP2138 is designed to help the immune system attack cancer cells by targeting a specific protein in the tumor. Participants will receive an injection of ASP2138 before surgery, followed by standard chemotherapy treatments. The trial seeks individuals with pancreatic cancer who have not yet received treatment and whose tumors can be surgically removed. 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 therapy.

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 does mention that you cannot have received any prior therapy for your pancreatic cancer. It's best to discuss your current medications with the study doctor to see if they might affect your eligibility.

Is there any evidence suggesting that ASP2138 is likely to be safe for humans?

Research has shown that ASP2138 is being tested for safety in individuals with certain cancers, such as pancreatic cancer. In earlier studies, researchers administered ASP2138 alone or with other standard treatments. These studies aimed to assess how well participants tolerated ASP2138 and to determine the appropriate dose.

Results indicated that ASP2138 is generally well-tolerated. Most side effects were mild to moderate, with some participants experiencing fatigue or injection site reactions, though these were not severe. Serious side effects were rare. However, as with any new treatment, risks exist. ASP2138 remains in the early stages of testing, so researchers continue to learn about its safety.

Prospective clinical trial participants should discuss any concerns with their doctor. A doctor can explain the trial's details and potential risks. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for pancreatic cancer?

Researchers are excited about ASP2138 for pancreatic cancer because it introduces a promising new approach by utilizing a novel mechanism of action. Unlike current treatments that primarily focus on chemotherapy combinations like mFOLFIRINOX or Gemcitabine-based regimens, ASP2138 is administered prior to surgery, potentially enhancing the effectiveness of subsequent chemotherapy. This pre-surgical treatment aims to shrink tumors and improve surgical outcomes, offering a fresh hope in tackling this aggressive cancer. Additionally, combining ASP2138 with personalized chemotherapy choices post-surgery could pave the way for more tailored and effective treatment strategies.

What evidence suggests that ASP2138 might be an effective treatment for pancreatic cancer?

Research has shown that ASP2138, which participants in this trial may receive, targets a protein called Claudin 18.2 (CLDN18.2) found in some pancreatic cancer tumors. This treatment attaches to CLDN18.2 and a protein on T-cells, a type of immune cell. The T-cells then assist the immune system in attacking the tumor. Although specific data on ASP2138's effectiveness in pancreatic cancer is still being gathered, similar methods have shown promise in other cancers with CLDN18.2. Early findings suggest that targeting this protein could offer a new way to effectively treat pancreatic cancer. ^{1 2 4 6 7}

Who Is on the Research Team?

Associate Medical Director

Principal Investigator

Astellas Pharma Global Development, Inc.

Are You a Good Fit for This Trial?

This trial is for adults with resectable pancreatic ductal cancer, meaning the tumor can be surgically removed. Participants must have a protein called CLDN18.2 in their tumors to qualify.

Inclusion Criteria

I am not pregnant and follow the required birth control measures.

Participant has at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Participant meets all laboratory test criteria within 7 days prior to the first dose of study intervention

Exclusion Criteria

I have an autoimmune disease and have been on systemic immunosuppressants in the last month.

I have an active hepatitis B or C infection.

Participant has any condition that may adversely affect the safe delivery of treatment or make the participant unsuitable for study participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Treatment

Participants receive ASP2138 injection subcutaneously for up to 4 weeks before surgery

4 weeks

Surgery

Participants undergo surgical resection of the pancreatic tumor

Adjuvant Chemotherapy

Participants receive standard chemotherapy treatments for up to 6 months post-surgery

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a final clinic visit about a month after finishing chemotherapy

1 month

What Are the Treatments Tested in This Trial?

Interventions

• ASP2138
• Standard Chemotherapy

Trial Overview The study tests ASP2138, which targets CLDN18.2 and T-cells to prompt an immune attack on the tumor. Before surgery, patients get ASP2138 subcutaneously; post-surgery they receive standard chemo like mFOLFIRINOX or gemcitabine combinations for up to 6 months.

How Is the Trial Designed?

Group I: ASP2138 and investigator's choice of adjuvant chemotherapy Experimental Treatment 8 Interventions

Participants will receive ASP2138 for up to 2 weeks prior to surgery. Following surgery participants will receive adjuvant chemotherapy (either mFOLFIRINOX \[modified leucovorin (folinic acid), 5-FU (fluorouracil), irinotecan and oxaliplatin\], Gemcitabine/Nab-paclitaxel, or Gemcitabine/Capecitabine) for up to 6 months or until meeting treatment discontinuation criteria.

Who Is Running the Clinical Trial?

Astellas Pharma Global Development, Inc.

Lead Sponsor

Trials

204

Recruited

123,000+

Tadaaki Taniguchi

Astellas Pharma Global Development, Inc.

Chief Medical Officer

M.D., Ph.D.

Naoki Okamura

Astellas Pharma Global Development, Inc.

Chief Executive Officer

Not available

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05365581

NCT05365581 | A Study of ASP2138 Given by Itself or ... ASP2138 is a potential treatment for people with stomach cancer, gastroesophageal junction cancer (GEJ cancer) or pancreatic cancer.

2. gioncologynow.com gioncologynow.com/post/safety-of-asp2138-alone-or-combined-in-cldn18-2-advanced-g-gej-cancer

Safety of ASP2138 Alone, Combined in CLDN18.2 ... A novel study adds insight into the safety profile of ASP2138 as monotherapy, in combination with 1L or 2L SOC options.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10951399/

Dark horse target Claudin18.2 opens new battlefield for ... The median overall survival (mOS) of patients with advanced pancreatic cancer is only 11.1 months (41), so there is an imperative need to find ...

4. duke-research.dukehealth.org duke-research.dukehealth.org/studies/pro00117793

ASP2138 monotherapy and chemotherapy for resectable ... We are doing this study to find out if an experimental drug called ASP2138 (the study drug) is a safe and effective option for people who have pancreatic cancer ...

5. kucancercenter.org kucancercenter.org/cancer-clinical-trials/find-trial/clinical-trial-results/study00160101

A Phase I/Ib Study of ASP2138 in Participants with ... A Phase I/Ib Study of ASP2138 in Participants with Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction GEJ Adenocarcinoma or ...

6. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-09348

A Study of ASP2138 Given by Itself or ... ASP2138 is a potential treatment for people with stomach cancer, gastroesophageal junction cancer, (GEJ cancer) or pancreatic cancer.

7. clinicaltrials.med.nyu.edu clinicaltrials.med.nyu.edu/cancer/clinicaltrial/2400/phase-11b-study-asp2138/

Perlmutter Cancer Center - Clinical Research Studies The main aims of the study are to check the safety of ASP2138, how well it is tolerated, and to find a suitable dose of ASP2138 to be used later in this study.