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

2025-522563-15-00 Protocol M25-288 Phase II and Phase III (Integrated) Authorised, recruitment pending

Status Authorised, recruitment pending · 2 EU/EEA countries · 9 sites · Protocol M25-288

Overview

Sponsor-declared trial summary

Phase Phase II and Phase III (Integrated)
Status Authorised, recruitment pending
Participants planned 780
Countries 2
Sites 9

Metastatic Pancreatic Ductal Adenocarcinoma; PDAC

Phase 2: • To evaluate the safety and tolerability of telisotuzumab adizutecan in combination with FOLFOX • To evaluate the efficacy of telisotuzumab adizutecan in combination with FOLFOX as measured by Objective Response (OR) per Blinded Independent Central Review (BICR) • To optimize and select the recommended Phase …

Key facts

Sponsor
AbbVie Deutschland GmbH & Co. KG
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Neoplasms [C04]
Decision date (initial)
2026-07-06
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes
Funding sources
AbbVie Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Others

Phase 2:
• To evaluate the safety and tolerability of telisotuzumab adizutecan in combination with FOLFOX
• To evaluate the efficacy of telisotuzumab adizutecan in combination with FOLFOX as measured by Objective Response (OR) per Blinded Independent Central Review (BICR)
• To optimize and select the recommended Phase 3 dose (RP3D) of telisotuzumab adizutecan in combination with FOLFOX

Phase 3:
• To evaluate the efficacy of telisotuzumab adizutecan in combination with FOLFOX compared with standard of care as measured by OR per BICR assessment and by Overall Survival (OS)

Secondary objectives 6

  1. Phase 2: To further evaluate the efficacy of telisotuzumab adizutecan in combination with FOLFOX as measured by Progression-Free Survival (PFS), Duration Of Response (DoR), and Clinical Benefit (CB) per BICR, and OS
  2. Phase 2: To characterize the pharmacokinetics (PK) and immunogenicity of telisotuzumab adizutecan in combination with FOLFOX
  3. Phase 3: To evaluate the efficacy of telistotuzumab adizutecan in combination with FOLFOX compared with standard of care as measured by PFS, DoR, and CB per BICR.
  4. Phase 3: To evaluate the safety and tolerability of telisotuzumab adizutecan in combination with FOLFOX compared with standard of care
  5. Phase 3: To evaluate the impact of telisotuzumab adizutecan in combination with FOLFOX on patient-reported function and pancreatic cancer symptoms as measured by the EORTC QLQ-C30 and EORTC QLQ-PAN26 compared with standard of care.
  6. Phase 3: To evaluate patient-reported tolerability and treatment-related side effects as measured by the FACT GP5 and PRO-CTCAE

Conditions and MedDRA coding

Metastatic Pancreatic Ductal Adenocarcinoma; PDAC

VersionLevelCodeTermSystem organ class
21.0 LLT 10033604 Pancreatic cancer 10029104

Regulatory references

Scientific advice from competent authorities
Food And Drug Administration, European Medicines Agency
Plan to share IPD
Yes
IPD plan description
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information. To learn more about the process, or to submit a request, visit https://www.abbvieclinicaltrials.com/hcp/data-sharing/ For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

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

Exclusion criteria 4

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

  1. Phase 2 and Phase 3: Objective response (OR) assessed by Blinded Independent CentralReview (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  2. Phase 3: Overall Survival

Secondary endpoints 9

  1. Phase 2 and Phase 3: Progression-Free Survival (PFS) assessed by BICR per RECIST v1.1
  2. Phase 2 and Phase 3: Duration Of Response (DoR) Assessed by BICR per RECIST v1.1
  3. Phase 2 and Phase 3: Clinical Benefit (CB) assessed by BICR per RECIST v1.1
  4. Phase 2 : Overall Survival
  5. Phase 3: Change from baseline and time to deterioration in scales/items of the EORTC QLQ-C30 and EORTC QLQ-PAN26
  6. Phase 3: Change in Selected items of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
  7. Phase 3: Change in GP5 item of the Functional Assessment of Cancer Therapy-General (FACT-G)
  8. Phase 3: Change in Selected items of Patient Global Impression of Severity (PGIS)/Patient Global Impression of Change (PGIC)
  9. Phase 3: Change from baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) utility index and visual analog scale (VAS)

Investigational products

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

Test 1

Telisotuzumab adizutecan

PRD11535908 · Product

Active substance
Telisotuzumab Adizutecan
Substance synonyms
ABBV-400, DC-1951796, Telisotuzumab conjugated to (2S)-2-(2-bromoacetamido)-N-[(2S)-1-({3-[(7S)-7-ethyl-7-hydroxy-8,11-dioxo-7,8,11,13-tetrahydro-2H,10H-[1,3]dioxolo[4,5-g]pyrano[3',4':6,7]indolizino[1,2-b]quinolin-14-yl]bicyclo[1.1.1]pentan-1-yl}amino)-1-oxopropan-2-yl]-3-methylbutanamide
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
00 mg milligram(s)
Max total dose
00 mg milligram(s)
Max treatment duration
24 Month(s)
Authorisation status
Not Authorised
MA holder
ABBVIE DEUTSCHLAND GMBH & CO. KG
Paediatric formulation
No
Orphan designation
No

Comparator 4

Oxaliplatin

SCP128961 · ATC

Active substance
Oxaliplatin
Route of administration
INTRAVENOUS
Max daily dose
00 mg milligram(s)
Max total dose
00 mg milligram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L01XA03 — OXALIPLATIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Fluorouracil

SCP1165178 · ATC

Active substance
Fluorouracil
Substance synonyms
5-FLOUROURACIL, 5-FLUORO-1H-PYRIMIDINE-2,4-DIONE, 5-FLUOROURACIL, 5-FU
Route of administration
INTRAVENOUS
Max daily dose
00 mg milligram(s)
Max total dose
00 mg milligram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L01BC02 — FLUOROURACIL
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Irinotecan Hydrochloride

SCP105621456 · ATC

Active substance
Irinotecan Hydrochloride
Route of administration
INTRAVENOUS
Max daily dose
00 mg milligram(s)
Max total dose
00 mg milligram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
L01CE02 — IRINOTECAN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Calcium Folinate

SCP107133400 · ATC

Active substance
Calcium Folinate
Substance synonyms
LEUCOVORIN CALCIUM
Route of administration
INTRAVENOUS
Max daily dose
00 mg milligram(s)
Max total dose
00 mg milligram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
V03AF03 — CALCIUM FOLINATE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AbbVie Deutschland GmbH & Co. KG

141 Total trials 49 Recruiting 87 Ended
Commercial
Sponsor organisation
AbbVie Deutschland GmbH & Co. KG
Address
Knollstrasse
City
Ludwigshafen Am Rhein
Postcode
67061
Country
Germany

Scientific contact point

Organisation
AbbVie Deutschland GmbH & Co. KG
Contact name
Global Clinical Trials Helpdesk

Public contact point

Organisation
AbbVie Deutschland GmbH & Co. KG
Contact name
Global Clinical Trials Helpdesk

Third parties 6

OrganisationCity, countryDuties
Endpoint Clinical Inc.
ORG-100040567
 Raleigh, United States Interactive response technologies (IRT)
Ventana Medical Systems Inc.
ORG-100043193
 Oro Valley, United States Laboratory analysis
Labcorp Central Laboratory Services SARL
ORG-100011524
 Meyrin, Switzerland Laboratory analysis
WCG Clinical Inc.
ORG-100040730
 Cary, United States Other
Clario
ORL-000001148
 Philadelphia, United States Other, E-data capture
Medidata Solutions Inc.
ORG-100016256
 New York, United States Other, Data management, E-data capture

Locations

2 EU/EEA countries · 9 investigational sites

By country

CountryMS statusPlanned subjectsSites
France Authorised, recruitment pending 50 5
Portugal Authorised, recruitment pending 24 4
Rest of world
Canada, United States, Israel, China, Australia, Korea, Republic of, Japan, Brazil, Taiwan, India
 — 706 —

Investigational sites

France

5 sites · Authorised, recruitment pending
Hopital Paul Brousse
Digestive and Medical Oncology, 12 Avenue Paul Vaillant Couturier, 94804, Villejuif Cedex
Centre Hospitalier Universitaire De Dijon
Hepato-gastro-enterology, 14 Rue Paul Gaffarel, 21000, Dijon
Centre Hospitalier Universitaire De Lille
Medical Oncology department, Rue Michel Polonowski, 59000, Lille
Hopitaux Universitaires Pitie Salpetriere
Hepato-gastro-enterology and digestive oncology, 47 To 83 Boulevard De L Hopital, 75013, Paris
Hospital Hotel Dieu
Oncology medical department, 1 Place Alexis Ricordeau, 44000, Nantes

Portugal

4 sites · Authorised, recruitment pending
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Oncology, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto
Unidade Local De Saude De Santa Maria E.P.E.
Oncology, Avenida Professor Egas Moniz, 1649-035, Lisbon
Champalimaud Clinical Centre
Oncology, Avenida Brasilia S/n, 1400-038, Lisbon
Unidade Local de Saude de Sao Joao E.P.E.
Oncology, Alameda Professor Hernani Monteiro, 4200-319, Porto

Results and documents

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

Documents 19 files

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

TypeTitleVersion
Protocol (for publication) D1_m25288-protocol_Public Redacted 1.2(EU)
Recruitment arrangements (for publication) K1 M25-288 FR Recruitment and ICF Procedures_Public 1.0
Recruitment arrangements (for publication) K1 M25-288 PT Recruitment and ICF Procedures_Public 1.0
Subject information and informed consent form (for publication) L1 M25-288 FR Continued Treatment ICF_Public 1.1
Subject information and informed consent form (for publication) L1 M25-288 FR Main ICF_Public Redacted 1.2
Subject information and informed consent form (for publication) L1 M25-288 FR Pregnancy Data Authorization ICF_Public 1.2
Subject information and informed consent form (for publication) L1 M25-288 PT Addendum ICF_Public Redacted 1.0
Subject information and informed consent form (for publication) L1 M25-288 PT Combined Main and Optional ICF_Public Redacted 1.0
Subject information and informed consent form (for publication) L1 M25-288 PT Pregnant Partner ICF_Public Redacted 1.0
Summary of Product Characteristics (SmPC) (for publication) E1_Fluorouracil_smpc 1
Summary of Product Characteristics (SmPC) (for publication) E1_Folinic acid_smpc 1
Summary of Product Characteristics (SmPC) (for publication) E1_Irinotecan_smpc 1
Summary of Product Characteristics (SmPC) (for publication) E1_Oxaliplatin_smpc 1
Synopsis of the protocol (for publication) D1_m25288-euctr-synopsis-DE-AT 1.0
Synopsis of the protocol (for publication) D1_m25288-euctr-synopsis-EN-EN 1.0
Synopsis of the protocol (for publication) D1_m25288-euctr-synopsis-ES-ES 1.0
Synopsis of the protocol (for publication) D1_m25288-euctr-synopsis-FR-FR 1.0
Synopsis of the protocol (for publication) D1_m25288-euctr-synopsis-IT-IT 1.0
Synopsis of the protocol (for publication) D1_m25288-euctr-synopsis-PT-PT 1.0

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2026-03-17 Portugal Acceptable with conditions
2026-07-06
 2026-07-06

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