CG Pharmaceuticals has unveiled promising results from their Phase 1b clinical trial investigating ivaltinostat in combination with capecitabine for the treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC). The findings were presented at the ASCO Gastrointestinal Symposium on January 24, 2025.
Phase 1b Trial Results
The study enrolled 28 patients with locally advanced or metastatic PDAC who had received at least one prior line of therapy. Participants received ivaltinostat at three different dose levels (60, 125, and 250 mg/m²) on days 1 and 8, combined with capecitabine (1000 mg/m², twice daily) on days 1-14 of a 21-day cycle.
The treatment demonstrated an encouraging safety profile across all dose levels. Most treatment-emergent adverse events (TEAEs) were mild to moderate (grade 1-2), with common effects including fatigue, nausea, palmar-plantar erythrodysesthesias, constipation, and diarrhea. Notably, no serious adverse events related to ivaltinostat were reported in any dose cohort.
Efficacy and Survival Data
As of the December 28, 2024 data cutoff, the trial showed promising efficacy results:
- 65% of patients demonstrated stable disease or no evidence of disease
- 14% experienced disease progression
- 22% were not evaluated
- Seven patients remained alive at data cutoff
- The longest-surviving patient reached 27 months
- Maximum treatment duration was 20 months
Among the 18 reported deaths, all were attributed to disease progression after study discontinuation, with no deaths directly related to the treatment regimen.
Advancing to Phase 2
Based on the Phase 1b results, researchers established the recommended Phase 2 dose (RP2D) of ivaltinostat at 250 mg/m². The ongoing Phase 2 randomized trial, which began in January 2024, is comparing ivaltinostat plus capecitabine versus capecitabine alone as maintenance therapy for mPDAC patients who have undergone first-line fluoropyrimidine-based therapy for at least four months without disease progression.
Current Trial Status
The Phase 2 study has made significant progress, achieving over 62% of its target enrollment across 17 U.S. clinical trial sites. CG Pharmaceuticals expects to complete patient enrollment and follow-ups within the year, with final study results anticipated by mid-2026.
This development represents a potentially important advance in the treatment landscape for metastatic pancreatic cancer, a disease with historically limited treatment options and poor survival rates.
