Dose Escalation (Phase 1) for Pancreatic Adenocarcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Pancreatic Adenocarcinoma+2 MoreASP2138 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

ASP2138 is a potential new treatment for people with stomach cancer, gastroesophageal junction cancer, or pancreatic cancer. Before ASP2138 is available as a treatment, the researchers need to understand how it is processed by and acts upon the body. They do this to find a suitable dose and to check for potential medical problems from the treatment. People who are 18 years or older can take part. This is an open-label study. This means that people in this study will know that they will receive ASP2138. The study will have 2 phases. Phase 1 is called dose escalation. Different small groups of people will take lower to higher doses of ASP2138. Medical problems will be recorded at each dose. This is done to find suitable doses of ASP2138 to use later in the study. Doctors will also check how each type of cancer is responding to ASP2138. Phase 1b is called dose expansion. Other different small groups will take part, and will take suitable doses of ASP2138 found from phase 1. This phase will check how each type of cancer responds to ASP2138. The response to ASP2138 is measured using x-rays, scans and blood tests. Doctors will continue to check all medical problems throughout the study. ASP2138 will be given through a vein in the arm. This is called an infusion. People will continue to receive treatment until: their disease gets worse; they have medical problems they can't tolerate; they ask to stop treatment; the doctors decide that continuing treatment is no longer in that person's best interest; the study is ended by the sponsor. Study doctors will check for any medical problems from ASP2138. Other checks will include physical exams, checking the nervous system, laboratory tests and vital signs. Nervous system checks include checking reflexes, balance, movement and muscle strength. Vital signs include body temperature, blood pressure and pulse. Electrocardiograms (ECG) will be done to check the heart rhythm during the study. People will receive ASP2138 in a hospital. They will give blood samples and study doctors will check for medical problems. People will also visit the clinic on certain days during their treatment, with extra visits during the first 3 cycles of treatment. People will visit the clinic after treatment has finished. The study doctors will check for more medical problems. Other checks will include physical exams, laboratory tests and vital signs. People will also have an ECG. After this, people will visit the clinic for a check-up several times. The number of visits and checks done at each visit will depend on the health of each person and whether they completed their treatment or not.

Eligible Conditions
  • Pancreatic Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma
  • Stomach Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

8 Primary · 10 Secondary · Reporting Duration: up to 21 months

Up to 12 months
Number of participants with electrocardiogram (ECG) abnormalities
PK of ASP2138 in serum: maximum concentration (Cmax)
PK of ASP2138 in serum: time of the maximum concentration (Tmax)
Pharmacokinetics (PK) of ASP2138 in serum: Area under the concentration-time curve (AUC) from the time of dosing to the start of the next dosing interval at multiple dose conditions (AUCtau)
Up to 12 motnhs
PK of ASP2138 in serum: concentration immediately prior to dosing at multiple dosing (Ctrough)
Up to 13 months
Number of participants at each grade of the Eastern Cooperative Oncology Group (ECOG) performance status
Number of participants with laboratory value abnormalities
Number of participants with physical exam abnormalities
Up to 15 months
Number of participants with Adverse Events (AEs)
Number of participants with serious AEs (SAEs)
Number of participants with vital sign abnormalities
Up to 21 months
Disease control rate (DCR) per RECIST 1.1 (Phase 1b dose expansion)
Duration of response (DOR) per RECIST 1.1
Overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (Phase 1b dose expansion)
Up to 28 days
Incidence of Dose Limiting Toxicities (DLTs) (Phase 1 Dose Escalation)
Up to 6 weeks
Change from baseline in claudin (CLDN) 18.2 tumor expression level
Change from baseline in programmed death-ligand 1 (PD-L1) tumor expression level
up to 21 months
Change from baseline in serum carbohydrate antigen 19-9 (CA19-9) (pancreatic only) (Phase 1b dose expansion)

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

Dose Escalation (Phase 1)
1 of 3
Dose Expansion (Phase 1b) Gastric/GEJ cancer
1 of 3
Dose Expansion (Phase 1b) Pancreatic cancer
1 of 3

Experimental Treatment

240 Total Participants · 3 Treatment Groups

Primary Treatment: Dose Escalation (Phase 1) · No Placebo Group · Phase 1

Dose Escalation (Phase 1)
Drug
Experimental Group · 1 Intervention: ASP2138 · Intervention Types: Drug
Dose Expansion (Phase 1b) Gastric/GEJ cancer
Drug
Experimental Group · 1 Intervention: ASP2138 · Intervention Types: Drug
Dose Expansion (Phase 1b) Pancreatic cancer
Drug
Experimental Group · 1 Intervention: ASP2138 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 21 months

Who is running the clinical trial?

Astellas Pharma Global Development, Inc.Lead Sponsor
184 Previous Clinical Trials
85,048 Total Patients Enrolled
Senior DirectorStudy DirectorAstellas Pharma Global Development, Inc.
9 Previous Clinical Trials
5,143 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Female participants must not donate ova starting at screening and throughout the study period and for 6 months after the final IP administration.
You are male and have a female partner of childbearing potential
You have a tumor sample that is positive for CLDN18.2 expression by central IHC testing.