Study of GS-2121 Given Alone or in Combination in Adults With Advanced Solid Tumors

Part of paid clinical trials in Palo Alto, California.

Sponsor
Gilead Sciences
Study ID
NCT06532565
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GS-2121 — DRUG
    Tablet administered orally
  • Zimberelimab — DRUG
    Administered intravenously

Study Details

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.

Key Dates

Start date
Jul 26, 2024
Status verified
Apr 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
154 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: GS-2121 Monotherapy Dose Escalation
    Participants will receive escalating doses of GS-2121 monotherapy until disease progression, or until the participant meets other study drug discontinuation criteria as specified in protocol.
  • Experimental: Part B: GS-2121 Monotherapy Dose Expansion
    Participants with selected indications will receive GS-2121 monotherapy at the recommended dose for expansion.
  • Experimental: Part C: Combination Dose Escalation of GS-2121 with Zimberelimab
    Participants will receive escalating doses of GS-2121 in combination with zimberelimab until disease progression, or until the participant meets other study drug discontinuation criteria as specified in protocol.
  • Experimental: Part D: Combination Dose Expansion of GS-2121 with Zimberelimab
    Participants with selected indications will receive GS-2121 at the recommended dose for expansion in combination with zimberelimab.

Primary Outcome Measure

Parts A and B: Percentage of Participants with Adverse Events and Serious Adverse Events [ Time Frame: First dose up to 90 days post last dose (up to approximately 118 weeks) ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Stanford Cancer CenterPalo AltoCalifornia94305-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
NEXT OncologySan AntonioTexas78229-
NEXT VirginiaFairfaxVirginia22031-

Find similar trials in Palo Alto, CA

By research site
Stanford Cancer Center· Palo Alto, CABeth Israel Deaconess Medical Center· Boston, MANEXT Oncology· San Antonio, TXNEXT Virginia· Fairfax, VA

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