Study of SPR1020 Taken Orally to Evaluate Safety and Effectiveness for Advanced Solid Tumors in Adults Phase III Open-Label Dose Escalation and Expansion Trial

What this Trial Is About

Researchers are evaluating SPR1020, a new selective PARP1 inhibitor, in adults with advanced solid tumors who have limited treatment options. This open-label, multicenter study aims to assess the safety, tolerability, pharmacokinetic profile, and preliminary antitumor activity of SPR1020. The drug is designed to target tumors with BRCA mutations or homologous recombination repair gene alterations, potentially offering improved safety and effectiveness compared to earlier PARP inhibitors, especially for patients with brain metastases. SPR1020 is given orally once daily in 21-day treatment cycles. The study has two main parts a Phase I dose-escalation and backfill segment to determine the optimal dose and evaluate safety, followed by a Phase II dose-expansion portion to further assess the drug at the recommended dose. Various dose levels from 25 mg to 250 mg per day are being studied. Participants receive the study drug until disease progression or other reasons for treatment end, with the possibility of dose adjustments as needed. Participants will undergo regular monitoring including safety assessments, pharmacokinetic sampling up to about 189 days, and tumor response evaluations using standard criteria. Adverse events will be tracked from the first dose through 30 days after the last dose or until new anti-tumor therapy begins, for up to one year. The study includes frequent lab tests and requires tumor and blood samples for genetic testing. Overall participation can last up to one year, with careful follow-up to evaluate both efficacy and safety outcomes.

An Open-label, First-in-Human, Dose-Escalation and Dose-Expansion Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SPR1020 in Patients With Advanced Solid Tumors