OMTX705 + Gemcitabine/Nab-Paclitaxel + Tislelizumab for Pancreatic Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment mix for individuals with advanced pancreatic cancer. It tests OMTX705, a drug targeting specific proteins in cancer cells, combined with existing drugs like gemcitabine, nab-paclitaxel (a chemotherapy drug), and tislelizumab (an immunotherapy drug). The trial seeks to determine the safest dose and assess how well the treatments work together. Individuals with pancreatic ductal adenocarcinoma (PDAC) that has progressed or cannot be surgically removed, and who have tried up to one other treatment option, might be suitable candidates. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.
Do I have to stop taking my current medications for the trial?
The trial requires that you stop taking medications that are strong inhibitors or inducers of certain liver enzymes (CYP3A4, 2D6, 1A2, 2C9, 2B6, and 2C19) at least 14 days before the first dose. If you're on these medications, you will need to stop them before participating.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that the combination of gemcitabine and nab-paclitaxel is generally safe for patients with pancreatic cancer. These studies confirmed that this combination works well and is usually manageable for patients in real-life settings, with most experiencing the treatment without severe side effects.
Research in animals has shown promising results for OMTX705, with significant slowing of tumor growth. However, this trial is among the first tests in humans, so information on its safety in people is limited. These early tests are crucial to assess patient tolerance.
Tislelizumab, another part of the trial, is also undergoing testing in other early studies to evaluate its safety. Researchers are examining its effects when used with the other drugs.
Overall, each part of this study is designed to closely monitor safety and determine the best dose. Participants in this trial will help researchers gather important safety information.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they combine innovative approaches with standard chemotherapy to tackle pancreatic cancer more effectively. OMTX705 is a novel agent that may work synergistically with existing drugs like gemcitabine and nab-paclitaxel, potentially enhancing their anticancer effects. Additionally, the inclusion of tislelizumab, an immune checkpoint inhibitor, offers a unique mechanism by enabling the immune system to better recognize and attack cancer cells. This combination approach might offer superior outcomes compared to the standard chemotherapy options alone, making it a promising direction for future pancreatic cancer treatments.
What evidence suggests that this trial's treatments could be effective for pancreatic cancer?
Research shows that OMTX705, a new treatment, may aid in fighting pancreatic cancer. This trial involves participants receiving different treatment combinations. In some arms, OMTX705 is combined with nab-paclitaxel and gemcitabine, which have already been shown to extend patient survival compared to gemcitabine alone. In other arms, OMTX705 is combined with nab-paclitaxel, gemcitabine, and tislelizumab, a drug that enhances the immune system to combat cancer. Early signs suggest that adding tislelizumab might be beneficial. Although more research is needed, these combination treatments could offer new hope for individuals with advanced pancreatic cancer.16789
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
Citations
Study Details | NCT07377045 | Clinical Trial of OMTX705 ...
Part 1 is intended to determine the safe recommended dose of OMTX705 in combination with gemcitabine/nab-paclitaxel (1A) and in combination with ...
2252P Peripheral immunological responses to ...
OMTX705 is a novel antibody-drug conjugate (ADC) targeting fibroblast activation protein (FAP) expressed on CAFs. Methods: Up to now, 17 patients with advanced ...
The effectiveness of nab-paclitaxel plus gemcitabine ... - PMC
FOLFIRINOX and nab-paclitaxel plus gemcitabine demonstrated a survival benefit compared to gemcitabine alone.
4.
aacrjournals.org
aacrjournals.org/clincancerres/article/26/13/3420/82545/OMTX705-a-Novel-FAP-Targeting-ADC-DemonstratesOMTX705, a Novel FAP-Targeting ADC Demonstrates Activity ...
Combination of paclitaxel with OMTX705 at 10 mg/kg was more effective than either drug alone at the same doses. OMTX705 alone at 30 mg/kg showed higher efficacy ...
5.
targetedonc.com
targetedonc.com/view/5-year-os-data-favor-nab-paclitaxel-with-gemcitabine-over-gemcitabine-alone-for-resected-pancreatic-cancer5-Year OS Data Favor Nab-Paclitaxel With Gemcitabine ...
At a median follow-up of 63.2 months, the 5-year OS rate was 38% among patients treated with nab-paclitaxel plus gemcitabine versus 31% for ...
Clinical Outcomes and Safety of Patients Treated with NAb ...
Our results confirm the efficacy and safety of a first-line regimen comprising gemcitabine and Nab-paclitaxel in metastatic PDAC in a real-life population.
Efficacy and toxicity of gemcitabine plus nab-paclitaxel in ...
The median progression-free survival (mPFS) was 3.7 months [95% confidence interval (CI): 2.5–5.3] and the median overall survival (mOS) was 5.6 ...
OMTX705, a powerful stroma-targeting ADC to treat ...
Results: OMTX705 showed 100% tumor growth inhibition and regression in the PDX murine models for pancreatic and NSCL cancer, both as single agent and in combina ...
Clinical Outcomes with First-Line Chemotherapy in a Large ...
The combination chemotherapy regimens of nab-paclitaxel plus gemcitabine (nab-p + G) and FOLFIRINOX (FFX) have each demonstrated improved survival compared with ...
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