A study to confirm the safety of ASP3082, and if it delays tumor growth in people with pancreatic cancer, when given with either mFOLFIRINOX or NALIRIFOX chemotherapies

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Astellas Pharma Global Development Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2026-06-12

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2025-523684-38-00

ClinicalTrials.gov

NCT07409272

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Pharmacokinetic, Therapy, Safety, Pharmacogenomic, Efficacy

To compare the overall survival (OS) between participants treated with ASP3082 plus mFOLFIRINOX or NALIRIFOX vs placebo plus mFOLFIRINOX or NALIRIFOX

Secondary objectives 7

1. To compare the progression-free survival (PFS) between participants treated with ASP3082 plus mFOLFIRINOX or NALIRIFOX vs placebo plus mFOLFIRINOX or NALIRIFOX
2. To compare time to improvement in pancreatic pain (TIPP)
3. To compare time to worsening of Global Health Status/Quality of Life (TWGQ)
4. To compare the objective response rate (ORR) between participants treated with ASP3082 plus mFOLFIRINOX or NALIRIFOX vs placebo plus mFOLFIRINOX or NALIRIFOX
5. To compare the safety and tolerability between participants treated with ASP3082 plus mFOLFIRINOX or NALIRIFOX vs placebo plus mFOLFIRINOX or NALIRIFOX
6. To evaluate the PK of ASP3082 (and metabolites, if applicable)
7. To evaluate impact on Quality of Life, functioning and symptoms in EORTC QLQ-PAN26, EORTC QLQ-C30, EQ-5D-5L, PGIC and PGIS

Conditions and MedDRA coding

Adult participants with metastatic PDAC with KRAS G12D mutation

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration, Pharmaceuticals And Medical Devices Agency, European Medicines Agency

Plan to share IPD

Yes

IPD plan description

Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. 1. Participant has histologically confirmed metastatic PDAC with documented KRAS G12D mutation based on local or central testing (a participant’s positive KRAS G12D mutation status result must be available prior to randomization).
2. 2. Participant has no option for surgical resection or radiotherapy with curative intent.
3. 3. Participant has KRAS G12D mutation from a tissue sample, based on local or central testing
4. 4. Participant has an ECOG PS of 0 or 1 within 7 days prior to randomization.
5. 5. Participant has adequate organ function

Exclusion criteria 6

1. 1. Participant has neuroendocrine, acinar pancreatic carcinoma or pancreatic cancer with squamous/adenosquamous features
2. 2. Participant has known low or absent DPD activity.
3. 3. Participant has homozygous UGT1A1 polymorphism
4. 4. Participant has received any radiotherapy within 14 days prior to the start of study intervention
5. 5. Participant has received any prior systemic therapy for their metastatic PDAC (except with up to 2 doses [i.e., 28 days; 1 cycle] of mFOLFIRINOX or NALIRIFOX during the screening period. If a participant received [neo]adjuvant chemotherapy, tumor recurrence or disease progression must have occurred ≥ 6 months after completing the last dose of the [neo]adjuvant therapy).
6. 6. Participant has had prior treatment with a KRAS G12D-targeted agent.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Overall Survival (OS), defined as the time from the date of randomization until the date of death from any cause

Secondary endpoints 7

1. Progression-free survival (PFS) per RECIST v1.1, as assessed by the investigator
2. TIPP, EORTC QLQ-PAN26
3. TWGQ, EORTC QLQ-C30
4. Objective response rate (ORR) per RECIST v1.1, as assessed by the investigator
5. Safety and tolerability evaluated via the following: AEs, SAEs, laboratory test results, ECGs, vital signs and ECOG Performance Status
6. End of infusion concentration and Ctrough
7. Change from baseline in EORTC QLQ-PAN26, EORTC QLQ-C30, EQ-5D-5L, PGIC and PGIS

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Astellas Pharma Global Development Inc.

Sponsor organisation

Astellas Pharma Global Development Inc.

Address

2375 Waterview Drive

City

Northbrook

Postcode

60062-6145

Country

United States

Scientific contact point

Organisation

Astellas Pharma Global Development Inc.

Contact name

Clinical Trial Unit Head

Public contact point

Organisation

Astellas Pharma Global Development Inc.

Contact name

Clinical Trial Unit Head

Third parties 16

Locations

5 EU/EEA countries · 79 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 51 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications