A Phase I Study to Evaluate the Safety and Tolerability of GS-4528 as Monotherapy and in Combination With an Anti-PD-1 Monoclonal Antibody in Adults With Advanced Solid Tumors
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Study Summary
The goals of this clinical study are to identify if GS-4528 alone or in combination with Anti-PD-1 Monoclonal Antibody is safe and tolerable in people with solid tumors and to identify the recommended dose of GS-4528 for further development that is safe to give to people alone or in combination with Anti-PD-1 Monoclonal Antibody.
The primary objectives of this study are:
- To assess the safety and tolerability of GS-4528 as monotherapy and in combination with Anti-PD-1 Monoclonal Antibody (negative immunoregulatory human cell surface receptor programmed cell death 1) in participants with advanced solid tumors.
- To identify the maximum tolerated dose (MTD)/maximum administered dose (MAD) and/or the recommended Phase 2 dose (RP2D) of GS-4528 as monotherapy and in combination with Anti-PD-1 Monoclonal Antibody in participants with advanced solid tumors.
- Key
- - 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
- - 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.
Clinical Study Information for Healthcare Providers
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