Study of GS-4528 in Adults With Solid Tumors

Launched by GILEAD SCIENCES · Apr 21, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called GS-4528 for adults with solid tumors, which are types of cancer that form in organs or tissues rather than blood. The goal is to find out if GS-4528 is safe to use on its own or when combined with another medication that helps the immune system fight cancer, known as an anti-PD-1 monoclonal antibody. Researchers will look for the best dose that patients can tolerate while ensuring their safety.

To participate in this study, individuals typically need to have a confirmed diagnosis of advanced solid tumors and must have already tried other cancer treatments without success or experienced significant side effects. Participants should be able to provide a tissue sample from their tumor and have a life expectancy of at least three months. Throughout the trial, participants will be monitored closely for any side effects and will have regular check-ups. It’s important to note that certain health conditions and recent treatments may exclude some individuals from joining the study.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• * Documented disease:
• • Phase 1a dose escalation and backfill cohorts; Phase 1b dose escalation: Individuals with histologically or cytologically confirmed advanced solid tumors who have received, been intolerant to, or been ineligible for all treatment known to confer clinical benefit or have a contraindication to receive the therapy.
• • Phase 1a dose expansion: Individuals with histologically or cytologically confirmed select indications who have received, been intolerant to, or been ineligible for all treatment known to confer clinical benefit or have a contraindication to receive the therapy.
• • Eastern Cooperative Oncology Group performance status 0 or 1.
• • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
• • Adequate organ function.
• • Individuals of childbearing potential who engage in heterosexual intercourse must agree to use method(s) of contraception.
• * Tissue requirements:
• • Phase 1a dose escalation, Phase 1a dose expansion, and Phase 1b dose escalation: Must provide pre-treatment adequate tumor tissue sample prior to enrolment.
• • Phase 1a backfill cohorts: Individuals must have fresh pre-treatment and on-treatment biopsy for biomarker analysis.
• • Life expectancy ≥ 3 months.
• Key Exclusion Criteria:
• • Positive serum pregnancy test or lactating female.
• • Prohibited concurrent anticancer therapy listed in the protocol.
• • Any anti-cancer therapy, whether investigational or approved, within protocol specified time prior to initiation of study including: major surgery (\<28 days), immunotherapy or biologic therapy (\< 28 days), chemotherapy (\< 21 days), targeted small molecule therapy (\< 14 days or \< 5 half-lives whichever is shorter), hormonal therapy or other adjunctive therapy (\< 14 days) or radiotherapy (\< 21 days).
• • Any prior allogeneic tissue/solid organ transplantation, including allogeneic stem cell transplantation.
• • Diagnosis of immunodeficiency, either primary or acquired, or systemic steroid requirement of \> 10 mg of prednisone or equivalent.
• • History of intolerance, hypersensitivity, or treatment discontinuation due to severe immune-related adverse events (irAEs) on prior immunotherapy.
• • History of autoimmune disease or active autoimmune disease that has required systemic treatment within 2 years prior to the start of study treatment.
• • Concurrent active second malignancy. Note: Individuals with a history of malignancy that have been completely treated, with no evidence of active cancer for 2 years prior to enrollment, or participants with surgically cured tumors with low risk of recurrence are allowed to enroll.
• • Have known active central nervous system (CNS) metastases and/ or carcinomatous meningitis.
• • Significant cardiovascular disease.
• • Have active serious infection requiring antibiotics.
• • Have active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
• • History of pneumonitis, interstitial lung disease, or severe radiation pneumonitis (excluding localized radiation pneumonitis).
• • Symptomatic ascites or pleural effusion.
• • Live vaccines within 28 days of initiation of investigational product(s).
• • Note: Other protocol defined Inclusion/Exclusion criteria may apply.