After promising phase 1 results, ART0380 will be studied in a randomized phase 2 trial for patients with platinum-resistant ovarian cancer.
A phase 2 trial recently launched, evaluating the novel drug ART0380 plus chemotherapy for patients with platinum-resistant ovarian cancer, according to Artios Pharma Limited, the manufacturer of ART0380.
The randomized phase 2 trial comes after a phase 1 trial showed that ART0380 was safe and tolerable and had cancer-fighting properties in patients with advanced solid tumors. The phase 1 trial also established the dosing for phase 2.
The phase 2 portion of the trial will continue to look at the safety, tolerability and drug-body interaction of ART0380 in combination with gemcitabine. ART0380 will be given in combination with gemcitabine in patients with high-grade serous ovarian cancer, primary peritoneal or fallopian tube carcinoma.
“Ovarian cancer continues to be a difficult to treat cancer that ultimately leads to relapse. We are excited to collaborate with Artios to help bring an ATR-targeted therapy with the potential to be highly effective in patients with platinum-resistant disease who are in much need of innovative treatment options,” Dr. Antonio Gonzalez-Martin, principal investigator on the trial and president and founding member of the Spanish Ovarian Cancer Research Group, said in a press release.
ART0380 works by targeting ATR, a protein believed to be involved in the replication stress response, which can lead to cancer progression.
“The favorable pharmacokinetic profile enabling combination with DNA damaging agents offers the potential of a new treatment option for patients with platinum-resistant ovarian cancer,” Gonzalez-Martin said.
Initial phase 2 data is expected to be released in 2025.
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