A Study to Assess Intravenous (IV) Telisotuzumab Adizutecan in Combination With Fluorouracil, Folinic Acid, and Oxaliplatin (FOLFOX) Compared to Standard of Care in Adult Participants With First-Line Metastatic Pancreatic Ductal Adenocarcinoma

[M25-288] Phase 2/3 Open Label Randomized Study of Telisotuzumab Adizutecan in Combination with FOLFOX Compared to Standard of Care in Subjects with First-Line Metastatic Pancreatic Ductal Adenocarcinoma - AndroMETa-PDAC-288

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031260004

Enrollment

900

Registered

2026-04-08

Start date

2026-04-08

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic ductal adenocarcinoma

Interventions

Drug: Telisotuzumab adizutecan Intravenous (IV) Infusion Drug: Irinotecan IV Infusion Drug: Fluorouracil IV Infusion Drug: Folinic acid/ Leucovorina IV Infusion Drug: Oxaliplatin IV Infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Have unresectable, metastatic histologically or cytologically confirmed adenocarcinoma of the pancreas. - Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. - Must consent to provide archived or recently obtained tumor tissue during Screening. - Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Exclusion criteria

Exclusion criteria: - Have prior systemic therapy, surgery, or radiation (except palliative radiation) in the unresectable, locally advanced or metastatic setting. - Prior c-MET targeting therapy. - History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD/ pneumonitis on screening chest computed tomography (CT) scan, including a history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis. - Prior bone marrow transplant, solid organ transplant, or previous clinical diagnosis of tuberculosis.

Design outcomes

Primary

Measure	Time frame
- Phase 2 and Phase 3: Overall Response (OR) Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 OR is defined as participants achieving a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) assessed by BICR per RECIST v1.1. [Time Frame: through study completion, approximately 6 years] - Phase 3: Overall Survival (OS) OS is defined as the time from date of randomization to the death from any cause. [Time Frame: through study completion, approximately 6 years]	—

Measure

Time frame

- Phase 2 and Phase 3: Overall Response (OR) Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 OR is defined as participants achieving a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) assessed by BICR per RECIST v1.1. [Time Frame: through study completion, approximately 6 years] - Phase 3: Overall Survival (OS) OS is defined as the time from date of randomization to the death from any cause. [Time Frame: through study completion, approximately 6 years]

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Secondary

Measure	Time frame
- Phase 2 and Phase 3: Progression-Free Survival (PFS) assessed by BICR per RECIST v1.1 PFS is defined as the time from the date of randomization or date of first dose of study treatment to the first occurrence of radiographic progression assessed by BICR per RECIST v1.1 or death from any cause, whichever occurs first. [Time Frame: through study completion, approximately 6 years] - Phase 2 and Phase 3: Duration Of Response (DoR) assessed by BICR per RECIST v1.1 DoR is defined as time from the initial response of Complete Response or Partial Response assessed by BICR per RECIST v1.1 to the first occurrence of radiographic progression assessed by BICR per RECIST v1.1 or death from any cause, whichever occurs first. [Time Frame: through study completion, approximately 6 years] - Phase 2 and Phase 3: Clinical Benefit (CB) assessed by BICR per RECIST v1.1 CB is defined as a participant achieving best overall response of confirmed CR or confirmed PR, or SD (with a minimum duration of 24 weeks) assessed by BICR per RECIST v1.1. [Time Frame: through study completion, approximately 6 years] - Phase 2 : Overall Survival (OS) OS is defined as the time from the date of randomization or date of first dose of study treatment to the event of death from any cause. [Time Frame: through study completion, approximately 6 years] - Phase 3: Change from baseline and time to deterioration in scale of the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire - Core 30-item (EORTC QLQ-C30) The EORTC QLQ-C30 is a 30-item patient-reported questionnaire composed of both multi-item and single scales including 5 functional scales, 3 symptom scales, a global health status/QoL scale, and 6 single items. Participants rate items on a 4-point scale ranging from 1 (not at all) to 4 (very much). [Time Frame: through study completion, approximately 6 years] - Phase 3: Change from baseline and time to deterioration in scale of the European Organisation for Research and	—

Measure

Time frame

- Phase 2 and Phase 3: Progression-Free Survival (PFS) assessed by BICR per RECIST v1.1 PFS is defined as the time from the date of randomization or date of first dose of study treatment to the first occurrence of radiographic progression assessed by BICR per RECIST v1.1 or death from any cause, whichever occurs first. [Time Frame: through study completion, approximately 6 years] - Phase 2 and Phase 3: Duration Of Response (DoR) assessed by BICR per RECIST v1.1 DoR is defined as time from the initial response of Complete Response or Partial Response assessed by BICR per RECIST v1.1 to the first occurrence of radiographic progression assessed by BICR per RECIST v1.1 or death from any cause, whichever occurs first. [Time Frame: through study completion, approximately 6 years] - Phase 2 and Phase 3: Clinical Benefit (CB) assessed by BICR per RECIST v1.1 CB is defined as a participant achieving best overall response of confirmed CR or confirmed PR, or SD (with a minimum duration of 24 weeks) assessed by BICR per RECIST v1.1. [Time Frame: through study completion, approximately 6 years] - Phase 2 : Overall Survival (OS) OS is defined as the time from the date of randomization or date of first dose of study treatment to the event of death from any cause. [Time Frame: through study completion, approximately 6 years] - Phase 3: Change from baseline and time to deterioration in scale of the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire - Core 30-item (EORTC QLQ-C30) The EORTC QLQ-C30 is a 30-item patient-reported questionnaire composed of both multi-item and single scales including 5 functional scales, 3 symptom scales, a global health status/QoL scale, and 6 single items. Participants rate items on a 4-point scale ranging from 1 (not at all) to 4 (very much). [Time Frame: through study completion, approximately 6 years] - Phase 3: Change from baseline and time to deterioration in scale of the European Organisation for Research and

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Countries

Japan, US

Contacts

Public ContactContact for Patients and HCP

AbbVie GK

AbbVie_JPN_info_clingov@abbvie.com+81-120-587-874

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jun 11, 2026