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Phase 2 Study of TTX-030 and Chemotherapy With or Without Budigalimab for 1L mPDAC Patients

T

Trishula Therapeutics

Status and phase

Enrolling
Phase 2

Conditions

Pancreatic Cancer

Treatments

Combination Product: TTX-030, nab-paclitaxel and gemcitabine
Combination Product: TTX-030, budigalimab, nab-paclitaxel and gemcitabine
Combination Product: Nab-Paclitaxel and gemcitabine

Study type

Interventional

Funder types

Industry

Identifiers

NCT06119217
TTX-030-003

Details and patient eligibility

About

This is a Phase 2, multicenter, open-label, 3-arm, randomized, parallel group study to evaluate the efficacy and safety of TTX-030 with or without budigalimab in combination with chemotherapy (gemcitabine + nab-paclitaxel) in subjects with metastatic PDAC who did not have prior treatment for metastatic disease and are eligible to receive gemcitabine and nab-paclitaxel chemotherapy as SOC.

Enrollment

180 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Abbreviated Inclusion Criteria:

  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 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

180 participants in 3 patient groups

Arm 1
Experimental group
Description:
TTX-030 plus nab-paclitaxel and gemcitabine
Treatment:
Combination Product: TTX-030, nab-paclitaxel and gemcitabine
Arm 2
Experimental group
Description:
TTX-030 plus budigalimab plus nab-paclitaxel and gemcitabine
Treatment:
Combination Product: TTX-030, budigalimab, nab-paclitaxel and gemcitabine
Arm 3
Active Comparator group
Description:
Nab-Paclitaxel and gemcitabine
Treatment:
Combination Product: Nab-Paclitaxel and gemcitabine

Trial contacts and locations

46

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Central trial contact

Trishula Therapeutics, Inc.

Data sourced from clinicaltrials.gov

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