NCT04938583

Oregovomab in Combination With Bevacizumab Plus Chemo in BRCA Wild Type Platinum Sensitive Recurrent Ovarian Cancer

Phase 1b/2, Single Arm Clinical Trial to Evaluate the Safety and Activity of Oregovomab and Bevacizumab, Paclitaxel Carboplatin as a Combinatorial Strategy in Subjects With BRCA-wild Type Platinum Sensitive Recurrent Ovarian Cancer

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: CanariaBio Inc. · Industry
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm phase 1b/2 evaluation of the combination of oregovomab, and bevacizumab, paclitaxel carboplatin in adult subjects with CA125-associated, advanced recurrent epithelial ovarian, fallopian tube or peritoneal carcinoma (FIGO Stage III/IV) with BRCA-wild type, previously treated with 1 prior lines of therapy, and with platinum free intervals of \>6 months since last platinum-based treatment.

Detailed description

This study is an open-label, single arm, phase 1b/II, multicenter study. In phase 1b part, the recommended phase 2 dose of oregovomab combined with bevacizumab, paclitaxel and carboplatin will be examined. Approximately 3 to 12 subjects("3+3" dose finding design) will be enrolled in phase 1b trial with starting dose of 2mg oregovmab. In Phase II trial, response rate of combination with oregovomab and bevacizumab, paclitaxel will be examined. Based on Simon's two stage model, 8 patients will be enrolled in first stage, after review of efficacy (response rate) of study treatment, 30 additional subjects for second stage of phase 2 will be enrolled. Considering 10% of screening failure rate, overall 42 patients will be enrolled in phase 2 trial.

Conditions

• Ovarian Cancer by FIGO Stage
• Ovarian Cancer Stage III
• Ovarian Cancer Stage IV

Interventions

Type	Name	Description
BIOLOGICAL	Oregovomab	Oregovomab will be administered on day1 cycle 1, 3, 5, and 9. A minimum of 3 patients will be enrolled into each cohort (2 mg or 1 mg). 2 mg (starting dose), dissolved in 2 mL of 0.9% Sodium Chloride Injection USP, then added to 50 mL of Sodium Chloride Injection USP infused over 20 ± 5 minutes
DRUG	Bevacizumab	15mg/Kg Day 1 (every 21 days) until progression
DRUG	Paclitaxel	175 mg/m\^2, Day 1 x 6 cycles (every 21 days)
DRUG	Carboplatin	AUC 5 IV Day 1 x 6 cycles (every 21 days)

Timeline

• Start date: 2021-03-17
• Primary completion: 2025-10-30
• Completion: 2026-08-31
• First posted: 2021-06-24
• Last updated: 2026-04-06

Locations

6 sites across 1 country: South Korea

Regulatory

• FDA-regulated drug study