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

NCT07377045 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2026-01-29

No results posted yet for this study

Summary

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).

Conditions

  • Pancreatic Adenocarcinoma Metastatic

Interventions

DRUG

OMTX705

OMTX705 administered IV at 2.0, 4.0 or 7.5 mg/kg on days 1 and 8 every 21-days cycle

DRUG

Nab-paclitaxel + Gemcitabine

Gemcitabine 1000 mg/m2 and nab-paclitaxel 125 mg/m2 administered IV on days 1 an8 every 21 days cycle

DRUG

Tislelizumab (i.v. 200mg)

Tislelizumab at 200 mg administered IV on day 1 of every 21-days cycle.

Sponsors & Collaborators

  • Oncomatryx Biopharma S.L.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-28
Primary Completion
2029-03-31
Completion
2029-03-31
FDA Drug
Yes

Countries

  • United States
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07377045 on ClinicalTrials.gov