Observing therapy response using liquid biopsy evaluation

SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation

This study is testing a new blood test to see if it can help track how well treatment is working for people with advanced solid tumors.

Quick facts

• Study type: Observational
• Enrollment: 470 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Guardant Health, Inc. (Industry-sponsored)
• Locations: 1 site (Skokie, Illinois)
• Trial ID: NCT05935384 on ClinicalTrials.gov

What this trial studies

The SIBYL study aims to collect clinical data to validate the effectiveness of a future version of the Guardant360 test in measuring responses to systemic therapy in patients with unresectable advanced solid tumors. Participants will be treated with standard care regimens while their treatment outcomes and ctDNA dynamics will be monitored. The study will correlate these dynamics with traditional evaluation methods such as RECIST 1.1 and CT scans to assess therapeutic response.

Who should consider this trial

Good fit: Ideal candidates include patients with unresectable advanced non-small cell lung cancer, colorectal cancer, or breast cancer who are starting or transitioning between systemic therapies.

Not a fit: Patients with a history of other malignancies within the past five years or those with a life expectancy of less than 12 weeks may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a non-invasive method for monitoring treatment responses in patients with advanced cancers.

How similar studies have performed: Other studies utilizing liquid biopsies for monitoring treatment responses have shown promising results, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria

Each participant must satisfy all the following criteria to be enrolled in the study:

1. Age ≥18 years old
2. Are treated with systemic therapy and/or oral SOC regimen at the site of enrollment during entirety of study
3. Patient is either treatment naive and has not yet commenced first line SOC therapy OR patient has completed first line SOC therapy and will commence second line of SOC therapy
4. Able to understand, and capable of providing written consent to participate in the study
5. Are willing to have de-identified clinical data shared with investigators at regular intervals outlined in the study protocol and informed consent
6. Are willing to provide blood samples at enrollment and at subsequent clinical visits
7. Have a histologically confirmed Index cancer that qualifies for inclusion, defined as:

   * Cohort 1: Unresectable Stage III/IV NSCLC (\~125)
   * Cohort 2: Stage IV Colorectal (\~125)
   * Cohort 3: Unresectable Stage III/IV Breast - HR+ HER2- (\~55)
   * Cohort 4: Unresectable Stage III/IV Breast - HR- HER2+ (\~55)
   * Cohort 5: Unresectable Stage III/IV Breast - HR+ HER2+ (\~55)
   * Cohort 6: Unresectable Stage III/IV Breast - Triple Negative (\~55) Determination of stage for eligibility assessment and enrollment should be based on clinical or pathologic stage.

Exclusion Criteria

Any potential participant who meets and of the following criteria at the time of initial enrollment will be excluded from participating in the study:

1. History of prior solid malignancy or hematological malignancy within five years of enrollment
2. Life expectancy ≤12 weeks
3. Unable to collect a baseline blood sample during a SOC venipuncture, and prior to starting SOC regimen
4. Is participating in a clinical trial or another observational study that is evaluating the performance of another genomic test for detecting/predicting clinical response/progression

Where this trial is running

Skokie, Illinois

• Orchard Healthcare Research Inc. — Skokie, Illinois, United States (Recruiting)

Study contacts

• Study coordinator: Clinical Trial Operations

Conditions Non-small Cell Lung Cancer; Colorectal Cancer; Breast Cancer