Phase 1 Study of STRO-002 and Bevacizumab in Advanced Epithelial Ovarian Cancer, Including Fallopian Tube and Primary Peritoneal Cancers

The primary objective of this study is to evaluate the **safety** and **pharmacokinetics** of STRO-002, an anti-Folate Receptor alpha (FolRα) antibody drug conjugate, in combination with **bevacizumab** in patients with advanced epithelial ovarian cancer, including fallopian tube or primary peritoneal cancers. This is clinically relevant as it aims to determine the tolerability and appropriate dosing of this combination therapy, which could potentially offer a new treatment option for patients with these advanced cancers. The study also seeks to assess the preliminary efficacy of this therapeutic regimen, providing insights into its potential impact on disease progression and patient outcomes.

The clinical trial involves a total of **38 participants** diagnosed with **Advanced Epithelial Ovarian Cancer**, including Fallopian Tube or Primary Peritoneal cancers. The study population is exclusively female, with an age range that includes adults and older adults. Participants were selected based on specific criteria, although the principal inclusion criteria are not provided. The trial does not include male subjects and involves a vulnerable population. Lifestyle considerations such as diet, physical activity, or habits are not specified in the available data. The sponsor has not provided detailed information regarding the general health status of the participants.

The clinical trial is a **Phase 1** open-label study designed to evaluate the safety, pharmacokinetics, and preliminary efficacy of STRO-002, an anti-folate receptor alpha antibody drug conjugate, in combination with bevacizumab in patients with **advanced epithelial ovarian cancer**, including fallopian tube or primary peritoneal cancers. The trial is expected to commence recruitment on September 1, 2022, and is estimated to conclude by December 31, 2027. The study employs a non-randomized, open-label design, allowing for the direct observation of treatment effects without the use of a placebo or control group.

Participants will undergo a series of study visits, beginning with an inclusion visit, which serves as a screening to determine eligibility based on predefined criteria. Following successful inclusion, participants will attend regular follow-up visits to monitor safety, assess pharmacokinetics, and evaluate preliminary efficacy. These visits will include clinical assessments, laboratory tests, and imaging studies as necessary. The end-of-study visit will mark the conclusion of the participant's involvement, during which final evaluations will be conducted to gather comprehensive data on the treatment's impact.

The expected duration of participant involvement will vary depending on individual response and tolerability, with the possibility of early termination if adverse events occur or if the participant withdraws consent. The study's design and procedures are structured to ensure rigorous data collection while prioritizing participant safety and adherence to ethical standards.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, or frequency of administration. As such, no detailed description of the experimental treatment can be provided based on the available data.

Similarly, there is no information available about any non-experimental treatments used in the study, such as standard-of-care therapy, placebo, or comparator treatment. Consequently, no description of these elements can be included.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. Therefore, no further details can be elaborated upon in this context.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 1 study, indicating an early stage of clinical research primarily focused on safety and dosage. The estimated recruitment start date is September 1, 2022, with an anticipated end date of December 31, 2027. Although specific efficacy parameters such as primary or secondary endpoints are not detailed, typical Phase 1 trials often involve preliminary assessments of efficacy alongside safety evaluations. These assessments may include the use of validated scales, laboratory tests, or patient-reported outcomes to measure potential therapeutic effects. The schedule for measuring and collecting data is not specified, but it is common in such trials to have multiple timepoints throughout the study duration to monitor changes and trends. The analysis of collected data will likely involve statistical methods appropriate for early-phase trials, focusing on identifying any initial signs of efficacy that warrant further investigation in subsequent trial phases.