Pancreatic Cancer
Conditions
Keywords
Cancer, Pancreatic Adenocarcinoma, Combination Therapy, CD39, Adenosine Pathway, Immunotherapy, Immuno-oncology, Pancreatic Ductal Adenocarcinoma, PD-1 Checkpoint Inhibitor, Budigalimab, TTX-030, metastatic
Brief summary
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.
Interventions
COMBINATION_PRODUCTTTX-030, nab-paclitaxel and gemcitabine
Dose and schedule per protocol
COMBINATION_PRODUCTTTX-030, budigalimab, nab-paclitaxel and gemcitabine
Dose and schedule per protocol
COMBINATION_PRODUCTNab-Paclitaxel and gemcitabine
Dose and schedule per protocol
Sponsors
Trishula Therapeutics, Inc.
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized, Parallel Group Study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) - Biomarker Enriched Population | Through study completion, an average of 1 year | PFS is defined as the time from randomization until first documentation of progression or death from any cause, whichever occurs first |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) - Overall Population | Through study completion, an average of 1 year | PFS is defined as the time from randomization until first documentation of progression or death from any cause, whichever occurs first. |
| Objective Response Rate (ORR) - Biomarker Enriched Population | Through study completion, an average of 1 year | Objective response rate (ORR) is defined as the proportion of subjects who achieve best overall response (BOR) of either complete response (CR) or partial response (PR) as assessed by the investigators per RECIST v1.1. The BOR is the best response (in the order of CR, PR, stable disease \[SD\], and progressive disease \[PD\]) documented from the date of randomization until the end of study, first disease progression, death, or start of new anti-cancer therapy, or last documented assessment before ≥2 consecutive missing tumor assessments, whichever is earlier. |
| Overall Survival (OS) - Biomarker Enriched Population | Through study completion | OS is defined as the time from randomization until death due to any cause. Participants who were lost to follow-up or survived until the end of the study were censored at the last date that they were known to be alive. Outcome measure is the Kaplan-Meier estimate of OS rate at 12 months. |
| Number of Participants With Treatment Emergent Adverse Events | Through study completion, up to a max of 2 years | Number of treatment emergent adverse events in all participants who received any dose of study treatment. |
Countries
Australia, France, Italy, South Korea, Spain, Taiwan, United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 34 Participants |
| Age, Categorical Between 18 and 65 years | 37 Participants |
| Body Mass Index | 23.50 kg/m^2 STANDARD_DEVIATION 4.169 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 18 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 13 Participants |
| Race (NIH/OMB) White | 29 Participants |
| Region of Enrollment Australia | 1 participants |
| Region of Enrollment France | 17 participants |
| Region of Enrollment Italy | 4 participants |
| Region of Enrollment South Korea | 12 participants |
| Region of Enrollment Spain | 11 participants |
| Region of Enrollment Taiwan | 17 participants |
| Region of Enrollment United States | 29 participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 36 / 66 | 33 / 60 | 34 / 68 |
| other Total, other adverse events | 64 / 66 | 59 / 60 | 63 / 68 |
| serious Total, serious adverse events | 38 / 66 | 40 / 60 | 29 / 68 |
Outcome results
None listed