Study of Denikitug (GS-1811) Given Alone or With Zimberelimab in Adults With Advanced Solid Tumors

Part of paid clinical trials in La Jolla, California.

Sponsor
Gilead Sciences
Study ID
NCT05007782
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Solid Tumor

Eligibility Criteria

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

Interventions

  • Denikitug — DRUG
    Administered Intravenously
  • Zimberelimab — DRUG
    Administered Intravenously

Study Details

This is a first-in-human (FIH) study to evaluate the safety and tolerability and to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of denikitug (also known as GS-1811) as monotherapy and in combination with zimberelimab in participants with advanced solid tumors. This study will be conducted in 6 parts (Parts A, B, and E: monotherapy, Parts C and D: combination therapy, and Part F for both monotherapy and combination therapy) in participants with advanced solid tumors who have received, been intolerant to, or been ineligible for all treatments known to confer clinical benefit or in participants with select solid tumors.

Key Dates

Start date
Aug 18, 2021
Status verified
Dec 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

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

Arms

  • Experimental: Part A - Denikitug Dose Escalation
  • Experimental: Part B - Mandatory Paired Tumor Biopsy
  • Experimental: Part C: Denikitug + Zimberelimab Dose Escalation
  • Experimental: Part D: Denikitug + Zimberelimab Dose Expansion
  • Experimental: Part E: Denikitug Monotherapy Dose Expansion
  • Experimental: Part F: Denikitug Monotherapy and In Combination With Zimberelimab In Select Dose and Schedule

Primary Outcome Measure

Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) in Part A and C [ Time Frame: Day 1 Through Day 21 ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
University of California San DiegoLa JollaCalifornia92093-
Stanford Cancer CenterPalo AltoCalifornia94305-
Smilow Cancer CenterNew HavenConnecticut06510-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Tennessee Oncology, PLLCNashvilleTennessee37203-
Sarah Cannon Research Institute at Mary CrowleyDallasTexas75230-
University of Texas Southwestern Medical CenterDallasTexas39090-
MD Anderson Cancer CenterHoustonTexas77030-
NEXT OncologySan AntonioTexas78229-
University of Wisconsin Clinical Sciences CenterMadisonWisconsin53705-

Find similar trials in La Jolla, CA

By research site
University of California San Diego· La Jolla, CAStanford Cancer Center· Palo Alto, CASmilow Cancer Center· New Haven, CTBeth Israel Deaconess Medical Center· Boston, MATennessee Oncology, PLLC· Nashville, TNSarah Cannon Research Institute at Mary Crowley· Dallas, TX

Related Studies