Phase 2 dose-expansion trial of OBI-3424, a DNA-alkylating prodrug, in patients with advanced solid tumors expressing AKR1C3.

What was studied

This trial tested OBI-3424 in advanced solid tumors. OBI-3424 is a prodrug that damages DNA. Patients had tumors with the AKR1C3 marker. One group had pancreatic cancer. Another group was a basket of other tumor types. Patients got the dose chosen in an earlier trial, 12 mg/m2 every 21 days. The trial checked safety, response and survival.

What they found

Of 29 patients treated, 26 could be checked for response. In pancreatic cancer, 40.0 of patients had stable disease. Median progression-free survival was 1.35 months. Median overall survival was 3.8 months. In the basket group, 1 patient out of 16 had a partial response. Stable disease occurred in 50. Median progression-free survival was 2.53 months and overall survival was 5.32 months. Common side effects were anemia, fatigue and low platelets.

What it means for patients

The authors say OBI-3424 had a favorable safety profile. They say limited efficacy led to early end of the trial.

Why it is not certain yet

The trial ended early. Few patients were in each group. There was no comparison group. Survival was short. The drug did not show enough benefit.

Source

Phase 2 dose-expansion trial of OBI-3424, a DNA-alkylating prodrug, in patients with advanced solid tumors expressing AKR1C3.

We restate facts from the source record in our own words. The original wording belongs to its publisher.