OMTX705 + Gemcitabine/Nab-Paclitaxel + Tislelizumab for Pancreatic Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a Phase 1b dose escalation trial of OMTX705, an anti-fibroblast activation protein (FAP) antibody-drug conjugate (ADC), in combination with gemcitabine/nab-paclitaxel and tislelizumab in patients with advanced/metastatic pancreatic ductal adenocarcinoma (PDAC).
The trial will be conducted in two parts (Part 1 and Part 2). Both parts will enroll participants with advanced PDAC that, in general, are eligible to receive gemcitabine/nab-paclitaxel. Part 1 is intended to determine the safe recommended dose of OMTX705 in combination with gemcitabine/nab-paclitaxel (1A) and in combination with gemcitabine/nab-paclitaxel+tislelizumab (1B). Both 1A and 1B will enroll in a standard 3+3 design. Only one dose level of OMTX705 will be selected for Part 2 by a Data Safety Monitoring Board (DSMB). In Part 2, 3 parallel randomized arms will be opened simultaneously with 1:1:1 randomization (N=15 each): OMTX705+gemcitabine/nab-paclitaxel (arm 2A), OMTX705+tislelizumab+gemcitabine/nab-paclitaxel (arm 2B) and gemcitabine/nab-paclitaxel (arm 2C, reference arm).
Are You a Good Fit for This Trial?
This trial is for adults with advanced or metastatic pancreatic cancer who can consent, have measurable disease, good performance status (able to carry out daily activities), and proper organ function. They must not have had more than one prior chemotherapy line and agree to use effective contraception.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation (Part 1)
Determine the safe recommended dose of OMTX705 in combination with gemcitabine/nab-paclitaxel and tislelizumab using a 3+3 design
Randomized Treatment (Part 2)
Participants are randomized into three arms to receive OMTX705 with gemcitabine/nab-paclitaxel, OMTX705 with tislelizumab and gemcitabine/nab-paclitaxel, or gemcitabine/nab-paclitaxel alone
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Nab-paclitaxel + Gemcitabine
- OMTX705
- Tislelizumab
Trial Overview
The study tests OMTX705 combined with gemcitabine/nab-paclitaxel and tislelizumab in two parts: finding a safe dose (Part 1) and comparing three treatment arms in randomized groups (Part 2). The goal is to see how well these combinations work for pancreatic cancer.
How Is the Trial Designed?
5
Treatment groups
Experimental Treatment
Part 1B limited dose escalation arm with three OMTX705 dose levels in combination with gemcitabine/nabpaclitaxel and tislelizumab at standard of care doses (starting dose level (DL1B), 4.0 mg/kg; escalating dose level (DL2B) 7.0 mg/kg; reduction dose level (DL-1B 2.0 mg/kg))
Part 1A limited dose escalation arm with three OMTX705 dose levels in combination with gemcitabine/nabpaclitaxel at standard of care doses (starting dose level (DL1A), 4.0 mg/kg; escalating dose level (DL2A) 7.0 mg/kg; reduction dose level (DL-1A 2.0 mg/kg))
Reference arm to calibrate safety and efficacy results from the two experimental arms 2A and 2B. Gemcitabine/nab-paclitaxel at standard of care doses.
OMTX705 at the dose selected by DSMB from Part 1B arm plus gemcitabine/nab-paclitaxel and tislelizumab at standard of care doses
OMTX705 at the dose selected by DSMB from Part 1A arm plus gemcitabine/nab-paclitaxel at standard of care doses
Find a Clinic Near You
Who Is Running the Clinical Trial?
Oncomatryx Biopharma S.L.
Lead Sponsor
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.