NCT06065462

Safety and Efficacy of Targeting PP2A in Ovarian Clear Cell Carcinoma Using Dostarlimab and LB-100

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To learn if the combination of dostarlimab and LB-100 can help to control ovarian clear cell carcinoma

Detailed description

Primary Objectives: 1\. To estimate overall survival in patients with recurrent ovarian clear cell carcinoma being treated with LB-100 and dostarlimab, including specific survival probabilities at 6 and 12 months. Secondary Objectives: 1. To describe clinically significant and immune related adverse events (ir-AEs) in the study population. 2. To determine the objective response rate (ORR), time to initial response, progression free survival (PFS), and duration of response (DOR) using modified RECIST v1.1 criteria. a. Although the clinical benefit of these drugs has not yet been established, the intent of offering this treatment is to provide a possible therapeutic benefit, and thus the patient will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability. 3. Translational: 1. To describe PP2A activity and immune changes, using baseline and on-treatment tumor biopsies and peripheral blood mononuclear cells (PBMCs) 2. To describe expression of mismatch repair proteins using immunohistochemistry (IHC) 3. To correlate circulating tumor DNA (ctDNA) levels with response by modified RECIST v1.1 criteria.

Conditions

• Ovarian Clear Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Dostarlimab	Given by vein (IV)
DRUG	LB-100	GIven by vein (IV)

Timeline

• Start date: 2023-11-10
• Primary completion: 2027-10-01
• Completion: 2027-10-01
• First posted: 2023-10-04
• Last updated: 2025-12-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study