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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06119217




Registration number
NCT06119217
Ethics application status
Date submitted
22/09/2023
Date registered
7/11/2023

Titles & IDs
Public title
Phase 2 Study of TTX-030 and Chemotherapy With or Without Budigalimab for 1L mPDAC Patients
Scientific title
An Open-Label Multicenter 3-Arm Randomized Phase 2 Study to Assess the Efficacy and Safety of TTX-030 and Chemotherapy With or Without Budigalimab, Compared to Chemotherapy Alone, for the Treatment of Patients Not Previously Treated for Metastatic Pancreatic Adenocarcinoma
Secondary ID [1] 0 0
TTX-030-003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - TTX-030, nab-paclitaxel and gemcitabine
Other interventions - TTX-030, budigalimab, nab-paclitaxel and gemcitabine
Other interventions - Nab-Paclitaxel and gemcitabine

Experimental: Arm 1 - TTX-030 plus nab-paclitaxel and gemcitabine

Experimental: Arm 2 - TTX-030 plus budigalimab plus nab-paclitaxel and gemcitabine

Active comparator: Arm 3 - Nab-Paclitaxel and gemcitabine


Other interventions: TTX-030, nab-paclitaxel and gemcitabine
Dose and schedule per protocol

Other interventions: TTX-030, budigalimab, nab-paclitaxel and gemcitabine
Dose and schedule per protocol

Other interventions: Nab-Paclitaxel and gemcitabine
Dose and schedule per protocol
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival (PFS) - Biomarker Enriched Population
Timepoint [1] 0 0
Through study completion, an average of 1 year
Secondary outcome [1] 0 0
Progression-free survival (PFS) - Overall Population
Timepoint [1] 0 0
Through study completion, an average of 1 year
Secondary outcome [2] 0 0
Objective Response Rate (ORR)
Timepoint [2] 0 0
Through study completion, an average of 1 year
Secondary outcome [3] 0 0
Duration of Response (DoR)
Timepoint [3] 0 0
Through study completion, an average of 1 year
Secondary outcome [4] 0 0
Overall Survival (OS)
Timepoint [4] 0 0
Through study completion, an average of 1 year
Secondary outcome [5] 0 0
Adverse Events
Timepoint [5] 0 0
Through study completion, an average of 1 year

Eligibility
Key inclusion criteria
Abbreviated

1. Age 18 years or older, is willing and able to provide informed consent
2. Histologically or cytologically confirmed diagnosis of metastatic PDAC.
3. No prior systemic treatment for metastatic disease.
4. Evidence of measurable disease per RECIST 1.1.
5. Appropriate for treatment with nab-paclitaxel and gemcitabine chemotherapy.
6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

Abbreviated
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of clinically significant allergy or hypersensitivity to planned study treatment components or to any monoclonal antibody
2. Use of investigational agent within 14 days prior to the first dose of study drug
3. History of autoimmune disease
4. Subject has received live vaccine within 28 days prior to the first dose of study drug
5. Has uncontrolled intercurrent illness

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2027
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Investigative Site - Albury
Recruitment hospital [2] 0 0
Investigative Site - Westmead
Recruitment hospital [3] 0 0
Investigative Site - Herston
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
Nevada
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
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North Carolina
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United States of America
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Ohio
Country [15] 0 0
United States of America
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Oregon
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United States of America
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Pennsylvania
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United States of America
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Texas
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United States of America
State/province [18] 0 0
Virginia
Country [19] 0 0
France
State/province [19] 0 0
Besançon
Country [20] 0 0
France
State/province [20] 0 0
Dijon
Country [21] 0 0
France
State/province [21] 0 0
Lille
Country [22] 0 0
France
State/province [22] 0 0
Paris
Country [23] 0 0
France
State/province [23] 0 0
Poitiers
Country [24] 0 0
Italy
State/province [24] 0 0
Genova
Country [25] 0 0
Italy
State/province [25] 0 0
Meldola
Country [26] 0 0
Italy
State/province [26] 0 0
Milano
Country [27] 0 0
Italy
State/province [27] 0 0
Modena
Country [28] 0 0
Italy
State/province [28] 0 0
Napoli
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Italy
State/province [29] 0 0
Pavia
Country [30] 0 0
Italy
State/province [30] 0 0
Puglia
Country [31] 0 0
Italy
State/province [31] 0 0
Verona
Country [32] 0 0
Korea, Republic of
State/province [32] 0 0
Goyang-si
Country [33] 0 0
Korea, Republic of
State/province [33] 0 0
Seongam
Country [34] 0 0
Korea, Republic of
State/province [34] 0 0
Seongnam-si
Country [35] 0 0
Korea, Republic of
State/province [35] 0 0
Seoul
Country [36] 0 0
Spain
State/province [36] 0 0
Barcelona
Country [37] 0 0
Spain
State/province [37] 0 0
Madrid
Country [38] 0 0
Spain
State/province [38] 0 0
Majadahonda
Country [39] 0 0
Spain
State/province [39] 0 0
Pamplona
Country [40] 0 0
Spain
State/province [40] 0 0
Valencia
Country [41] 0 0
Spain
State/province [41] 0 0
Zaragoza
Country [42] 0 0
Taiwan
State/province [42] 0 0
Kaohsiung
Country [43] 0 0
Taiwan
State/province [43] 0 0
Taichung
Country [44] 0 0
Taiwan
State/province [44] 0 0
Tainan
Country [45] 0 0
Taiwan
State/province [45] 0 0
Taipei
Country [46] 0 0
Taiwan
State/province [46] 0 0
Taoyuan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Trishula Therapeutics, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
AbbVie
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Trishula Therapeutics, Inc.
Address 0 0
Country 0 0
Phone 0 0
+1 888-480-0554
Fax 0 0
Email 0 0
clinicaltrials@trishulatx.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06119217