Clinical Trial of OMTX705 in Combination With Gemcitabine/Nab-Paclitaxel and Tislelizumab in Patients With Advanced/Metastatic Pancreatic Adenocarcinoma

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Oncomatryx Biopharma S.L.
Study ID
NCT07377045
Phase
PHASE1
Status
Recruiting
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Conditions

  • Pancreatic Adenocarcinoma Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • OMTX705 — DRUG
    OMTX705 administered IV at 2.0, 4.0 or 7.5 mg/kg on days 1 and 8 every 21-days cycle
  • Nab-paclitaxel + Gemcitabine — DRUG
    Gemcitabine 1000 mg/m2 and nab-paclitaxel 125 mg/m2 administered IV on days 1 an8 every 21 days cycle
  • Tislelizumab (i.v. 200mg) — DRUG
    Tislelizumab at 200 mg administered IV on day 1 of every 21-days cycle.

Study Details

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).

Key Dates

Start date
Oct 28, 2025
Status verified
Nov 2025
Primary completion
Mar 31, 2029
Completion
Mar 31, 2029

Study Design

Enrollment
69 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1A
    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))
  • Experimental: Part 1B
    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))
  • Experimental: Arm 2A (Part 2)
    OMTX705 at the dose selected by DSMB from Part 1A arm plus gemcitabine/nab-paclitaxel at standard of care doses
  • Experimental: Arm 2B (Part 2)
    OMTX705 at the dose selected by DSMB from Part 1B arm plus gemcitabine/nab-paclitaxel and tislelizumab at standard of care doses
  • Other: Arm 2C (Part 2)
    Reference arm to calibrate safety and efficacy results from the two experimental arms 2A and 2B. Gemcitabine/nab-paclitaxel at standard of care doses.

Primary Outcome Measure

Number of participants with dose limiting toxicities (DLTs) during Part 1 of the study [ Time Frame: At Day 1, Day 8 and Day 15 of the first 21-day cycle, and up to Day 1 of the second 21-day cycle. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical Center (BIDMC)BostonMassachusetts02215
Bruno Bockorny
[email protected]
617-667-2100

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By research site
Beth Israel Deaconess Medical Center (BIDMC)· Boston, MA

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