Efficacy and Safety Study of OMTX705, Monotherapy and Anti-PD-1-combined, in Subjects With Advanced Solid Tumors.

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Oncomatryx Biopharma S.L.
Study ID
NCT05547321
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumor

Eligibility Criteria

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

Interventions

  • OMTX705 — DRUG
    The investigational product is OMTX705 administered as monotherapy at different escalation doses.
  • Pembrolizumab — DRUG
    Pembrolizumab at 200 mg administered in combination with different escalation doses of OMTX705.
  • OMTX705 — DRUG
    The investigational product is OMTX705 administered as monotherapy at 10 mg/kg
  • OMTX705 — DRUG
    The investigational product is OMTX705 administered as monotherapy at 15 mg/kg
  • OMTX705 — DRUG
    The investigational product is OMTX705 administered as monotherapy at 7.5 mg/kg
  • Tislelizumab (BGB-A317) — DRUG
    Tislelizumab at 200 mg is administered in combination with OMTX705
  • OMTX705 — DRUG
    The investigational product is OMTX administered at 4.0 mg/kg

Study Details

Open-label, two parallel arm, multicenter, Phase 1 dose-escalation study to evaluate the safety and tolerability of OMTX705, both as monotherapy or in combination with pembrolizumab (Part 1) or tislelizumab (Part 2) in the treatment of patients with advanced or metastatic cancer in whom there is no available standard therapeutic option.

Key Dates

Start date
Oct 20, 2022
Status verified
Nov 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Monotherapy (OMTX705)
    Part 1: OMTX705 is administered as single agent at diffrent escalation doses.
  • Experimental: Combination (OMTX705 + pembrolizumab)
    Part 1: OMTX705 at different escalation doses is administered in combination with pembrolizumab at 200 mg.
  • Experimental: SARC1
    Part 2: OMTX705 is administered as single agent in FAP positive patients at 10 mg/kg
  • Experimental: PDAC Low
    Part 2: OMTX705 is administered at 4.0 mg/kg in combination with tislelizumab at 200 mg
  • Experimental: PDAC High
    Part 2: OMTX705 is administered at 7.5 mg/kg in combination with tislelizumab at 200 mg
  • Experimental: SCHED1
    Part 2: OMTX705 is administered as single agent at 15 mg/kg
  • Experimental: BIOPSY
    Part 2: OMTX705 is administered as single agent at 7.5 mg/kg

Primary Outcome Measure

Safety evaluation of OMTX705 [ Time Frame: Through study completion, an average of 42 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Bruno Bockorny, MD

Find similar trials in Boston, MA

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

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