Study of GS-2121 Given Alone or in Combination in Adults With Advanced Solid Tumors
ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorGilead Sciences
About this trial
The main goal of this first-in-human (FIH) study is to learn about the safety and dosing of GS-2121 when given alone or in combination with zimberelimab (ZIM) in participants with advanced solid tumors.
The primary objectives of this study are:
* To assess the safety and tolerability of GS-2121 as monotherapy and GS-2121 in combination with zimberelimab 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-2121 as monotherapy and in combination with zimberelimab in participants with advanced solid tumors.
Eligibility criteria
Qualifiers
Participants diagnosed with histologically or cytologically confirmed advanced solid tumors who have progressed despite standard therapy, are intolerant to standard therapy, or are ineligible for standard therapy.
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
Parts A-D: Pre-treatment tumor tissue is required.
Disqualifiers
Positive serum pregnancy test or participant who is breastfeeding.
Requirement for ongoing therapy with any prohibited medications.
Any anti-cancer therapy, whether investigational or approved within protocol specified time prior to initiation of study including: major surgery (<4 weeks), experimental therapy (<21 days or <5 half-lives whichever is shorter), approved immunotherapy or biologic therapy (<28 days), approved chemotherapy (<21 days or <42 days for mitomycin or nitrosoureas), approved targeted small molecule therapy (<14 days or <5 half-lives whichever is longer), hormonal therapy or other adjunctive therapy for cancers other than cancer under evaluation in this study (<14 days) or radiation therapy (<21 days).
Any prior allogeneic tissue/solid organ transplantation, including allogeneic stem cell transplantation.
Trial design
Treatments tested in this trial
- GS-2121
- Zimberelimab
Treatment groups
154 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov