NCT05547321

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

Phase 1 Dose-escalation Trial of OMTX705, an Anti-fibroblast Activation Protein Antibody-drug Conjugate, as Single Agent and in Combination With Anti-PD-1 in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Oncomatryx Biopharma S.L. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The study consists of 2 parts: * Part 1: Phase 1 dose-escalation with two parallel staggered escalation cohorts: one cohort of patients treated with OMTX705 as monotherapy and one cohort of patients receiving escalating doses of OMTX705 in combination with standard pembrolizumab. The combination arm will start once OMTX705 monotherapy safety has been evaluated. * Part 2: Five cohorts expansions have been projected to confirm the safety of OMTX705 as monotherapy (SCHED1, SARC1 and BIOPSY) and in combination with tislelizumab (PDAC\_Low and PDAC\_High) will provide additional efficacy and safety information. For Part 1 (escalation phase) the classical 3+3 design will be followed to establish the maximum tolerated dose (MTD) or the provisional recommended dose for the Part 2 or expansion phase (RP2D). Three to six patients per treatment cohort will be assigned to receive sequentially higher doses of OMTX705 on Days 1 and 8 in cycles of 21 days. The OMTX705 starting dose is 1.0 mg/kg Dose escalation will be based on a review of all parameters critical to subject safety from C1D1 to the start of C2D1. A safety report will be reviewed by the safty review committee (SRC) to determine if progression to the next planned dose level should occur or if additional subjects or lower dose levels are needed. Expansion phase (Part 2): Based on the results observed in Part 1, five cohort expansions will provide additional safety and efficacy information and will support the selection of the RP2D and indications to be tested in future efficacy studies. All patients allocated to receive OMTX705 in combination, will receive the anti-PD-1 tislelizumab. For this particular purpose the following cohorts will be opened: * Cohort SARC1: OMTX705 in monotherapy at 10 mg/kg in sarcomas expressing FAP with H-score in cancer cells ≥40 or 2+/3+. * Cohort PDAC\_low: OMTX705 at 4.0 mg/kg in combination with tislelizumab in patients with stage IV PDAC. * Cohort PDAC\_high: OMTX705 at 7.5 mg/kg in combination with tislelizumab in patients with stage IV PDAC. * Cohort SCHED1: Part 1 patient population to receive OMTX705 at 15 mg/kg in monotherapy on Day 1 every 21 days with the possibility to escalate up to 20 mg/kg. * Cohort BIOPSY: patients with selected indications for which in Part 1 there are hints of antitumor activity who volunteer for paired fresh biopsies. They will receive OMTX705 at 7.5 mg/kg with tislelizumab. After treatment discontinuation, patients will have the EoT visit 30 (±2) days after the last dose of any component of the treatment for the evaluation of new AEs or recovery from previous ones. EoT visit can be anticipated for patients scheduled to receive the next line of systemic treatment to the day of the start of the new therapy if this happens less than 30 days after the last dose of study treatment. Subjects who discontinue study treatment for reasons other than progressive disease (PD) will continue to attend PFS Follow-up (FU) Visits every 12 (±1) weeks from the EoT Visit until the occurrence of PD, loss to follow up, consent withdrawal, death, the start of subsequent systemic antineoplastic therapy, or study termination, whichever occurs first. Only patients enrolled in Part 2 will be followed for survival. To assess survival status, subjects will be contacted (which may be by phone or hospital visit, whichever is preferable) every 3 months from the first dose of OMTX705.

Conditions

• Advanced Solid Tumor

Interventions

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

Timeline

• Start date: 2022-10-20
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2022-09-21
• Last updated: 2025-11-25

Locations

9 sites across 2 countries: United States, Spain

Regulatory

• FDA-regulated drug study