378 Participants Needed

ASP2138 for Digestive System Cancers

Recruiting at 41 trial locations
AP
Overseen ByAstellas Pharma Global Development, Inc.
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Astellas Pharma Global Development, Inc.
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 is testing a new drug called ASP2138 for adults with advanced stomach, gastroesophageal junction, or pancreatic cancer. ASP2138 helps the immune system target and attack cancer cells. The study aims to find a safe and effective dose and monitor any side effects. Participants will receive the drug through an IV or injection and will be closely monitored throughout the study.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants who have received other investigational agents or antineoplastic therapy within 21 days prior to the first dose are excluded. It's best to discuss your current medications with the trial team to get specific guidance.

How does the drug ASP2138 work differently for digestive system cancers?

ASP2138 targets the p38 MAP kinase pathway, which plays a dual role in colorectal cancer by both suppressing tumor initiation and supporting cancer cell survival. This drug may offer a novel approach by potentially inhibiting cancer cell growth while also addressing inflammation-related tumorigenesis, making it different from standard treatments that do not specifically target this pathway.12345

Who Is on the Research Team?

SD

Senior Director

Principal Investigator

Astellas Pharma Global Development, Inc.

Are You a Good Fit for This Trial?

Adults with advanced stomach, gastroesophageal junction, or pancreatic cancer that can't be removed by surgery or has spread are eligible. They must not be pregnant or breastfeeding and agree to contraception. Their tumors should express CLDN18.2 protein and they should have a life expectancy of at least 12 weeks.

Inclusion Criteria

I am a man who will use birth control during and for 6 months after treatment.
My tumor tested positive for CLDN18.2.
I have cancer in my stomach or where my esophagus meets my stomach.
See 15 more

Exclusion Criteria

I weigh less than 40 kg.
I have severe blockage in my stomach causing vomiting.
I haven't had serious heart issues like a heart attack or unstable angina in the last 6 months.
See 19 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 1

Participants receive escalating doses of ASP2138 alone or in combination with standard cancer treatments to determine the maximum tolerated dose and recommended phase 2 dose.

Up to 15 months
Weekly visits during treatment cycles

Treatment Phase 1b

Participants receive ASP2138 at the recommended phase 2 dose to evaluate cancer response and safety.

Up to 21 months
Regular visits for safety checks and response evaluation

Follow-up

Participants are monitored for safety and effectiveness after treatment completion.

Several months, depending on individual health status
Several visits for health checks

What Are the Treatments Tested in This Trial?

Interventions

  • ASP2138
Trial Overview The trial is testing ASP2138, which targets both the tumor cell and an immune cell protein to direct the immune system against the tumor. It's given as an infusion in two phases: first to find a safe dose by escalating amounts in small groups, then using those doses to see how different cancers respond.
How Is the Trial Designed?
9Treatment groups
Experimental Treatment
Group I: Monotherapy Dose Expansion (Phase 1b) Pancreatic cancerExperimental Treatment1 Intervention
Group II: Monotherapy Dose Expansion (Phase 1b) Gastric/GEJ cancerExperimental Treatment1 Intervention
Group III: Monotherapy Dose Escalation (Phase 1)Experimental Treatment1 Intervention
Group IV: Combination Therapy Dose Escalation (Phase 1) Part I - First line Pancreatic CancerExperimental Treatment5 Interventions
Group V: Combination Therapy Dose Escalation (Phase 1) Part H - Second-line Gastric/GEJ CancerExperimental Treatment3 Interventions
Group VI: Combination Therapy Dose Escalation (Phase 1) Part G - First-line Gastric/GEJ CancerExperimental Treatment5 Interventions
Group VII: ASP2138 + mFOLFIRINOX Combination Therapy Dose Expansion (Phase 1b) Pancreatic CancerExperimental Treatment5 Interventions
Group VIII: ASP2138 + Ramucirumab & Paclitaxel Combination Therapy Dose Expansion (Phase 1b) Gastric/GEJ CancerExperimental Treatment3 Interventions
Group IX: ASP2138 + Pembrolizumab & mFOLFOX6 Combination Therapy Dose Expansion (Phase 1b) Gastric/GEJ CancerExperimental Treatment5 Interventions

Find a Clinic Near You

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 profile image

Naoki Okamura

Astellas Pharma Global Development, Inc.

Chief Executive Officer

Not available

Published Research Related to This Trial

Deleting p38-MAPK in the intestinal epithelium of mice led to a significant increase in tumor development, with epithelial-deleted mice developing an average of 3.7 tumors compared to 1.1 in wild-type mice, indicating that p38-MAPK plays a crucial role in suppressing tumorigenesis in the colon.
The study suggests that the increased tumor burden in p38-MAPK deficient mice is likely due to impaired cell cycle regulation rather than increased inflammation, highlighting the potential for targeting p38-MAPK as a therapeutic strategy in colorectal cancer, especially for patients with inflammatory bowel disease.
Deletion of p38-alpha mitogen-activated protein kinase within the intestinal epithelium promotes colon tumorigenesis.Wakeman, D., Schneider, JE., Liu, J., et al.[2021]
A study found that the -1628G variant allele of the p38β promoter SNP (rs2235356) is associated with nearly double the risk of developing sporadic colorectal cancer (CRC), based on a case-control analysis involving genotyping of participants.
The SNP affects the binding of transcription factors to the p38β promoter, suggesting that this genetic variant may influence CRC susceptibility through changes in gene regulation.
A genetic variation of the p38β promoter region is correlated with an increased risk of sporadic colorectal cancer.Huang, Q., Chen, D., Song, S., et al.[2021]
The p38α signaling pathway plays a protective role in preventing colitis-associated colon cancer by maintaining the integrity of the intestinal epithelial barrier, as its downregulation leads to increased inflammation and epithelial damage.
Interestingly, while p38α helps prevent tumor formation in normal epithelial cells, its inhibition in cancerous colon cells can actually reduce tumor burden, highlighting its complex role in colorectal tumorigenesis.
Dual function of p38α MAPK in colon cancer: suppression of colitis-associated tumor initiation but requirement for cancer cell survival.Gupta, J., del Barco Barrantes, I., Igea, A., et al.[2022]

Citations

Deletion of p38-alpha mitogen-activated protein kinase within the intestinal epithelium promotes colon tumorigenesis. [2021]
A genetic variation of the p38β promoter region is correlated with an increased risk of sporadic colorectal cancer. [2021]
Dual function of p38α MAPK in colon cancer: suppression of colitis-associated tumor initiation but requirement for cancer cell survival. [2022]
PP2AC Level Determines Differential Programming of p38-TSC-mTOR Signaling and Therapeutic Response to p38-Targeted Therapy in Colorectal Cancer. [2021]
Pharmacological targeting of the novel β-catenin chromatin-associated kinase p38α in colorectal cancer stem cell tumorspheres and organoids. [2023]
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