Vilastobart (XTX101) Monotherapy and Vilastobart and Atezolizumab Combination Therapy in Advanced Solid Tumors

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Xilio Development, Inc.
Study ID
NCT04896697
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Advanced Solid Tumor

Eligibility Criteria

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

Interventions

  • vilastobart (XTX101) — DRUG
    vilastobart (XTX101) monotherapy
  • Atezolizumab — DRUG
    1200 mg administered every 3 weeks in combination with vilastobart (XTX101)
  • vilastobart (XTX101) — DRUG
    In combination with Atezolizumab

Study Details

This is a first-in-human, Phase 1/2, multicenter, open-label study designed to evaluate the safety and tolerability of vilastobart (XTX101) as monotherapy and vilastobart (XTX101) and atezolizumab combination therapy in patients with advanced solid tumors.

Key Dates

Start date
Sep 13, 2021
Status verified
Apr 2026
Primary completion
Jun 12, 2026
Completion
Jun 12, 2026

Study Design

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

Arms

  • Experimental: Part 1A - vilastobart (XTX101) Monotherapy Dose Escalation
    Part 1A Dose Escalation of vilastobart (XTX101) administered in ascending doses to patients with advanced or metastatic solid tumors to find the recommended phase 2 dose (RP2D).
  • Experimental: Part 1B - Pharmacodynamic (PD) Dose Expansion
    Part 1B vilastobart (XTX101) at the RP2D will be administered to further examine vilastobart (XTX101) as monotherapy in patients with select advanced solid tumors.
  • Experimental: Part 1C - vilastobart (XTX101) Dose Escalation and Dose Expansion in Combination with Atezolizumab
    Part 1C will receive a labeled dose of atezolizumab in combination with vilastobart (XTX101).
  • Experimental: Phase 2 - vilastobart (XTX101) Dose Expansion in Combination with Atezolizumab
    Phase 2 will receive a labeled dose of atezolizumab in combination with vilastobart (XTX101) at the RP2D(s) in patients with MSS CRC.

Primary Outcome Measure

Incidence of Dose Limiting Toxicities (DLTs) in Part 1A [ Time Frame: Cycle 1 Day 1 up to just prior to the second dose of study drug at Cycle 2 day 1 (approximately 3 weeks) ]

Locations (19)

FacilityCityStateZIPSite coordinators
Mayo Clinic HospitalPhoenixArizona85054-
City of HopeDuarteCalifornia91010-
California Cancer Associates for Research and Excellence, cCAREEncinitasCalifornia92024-
City of Hope-LennarIrvineCalifornia92618-
USC/Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
California Cancer Associates for Research and Excellence, cCARESan MarcosCalifornia92069-
UCLA Hematology/Oncology- Santa MonicaSanta MonicaCalifornia90404-
City of Hope-UplandUplandCalifornia91786-
Mayo Clinic HospitalJacksonvilleFlorida32224-
Sarah Cannon Research Institute at Florida Cancer SpecialistsOrlandoFlorida32827-
Massachusetts General HospitalBostonMassachusetts02114-
Mayo Clinic HospitalRochesterMinnesota55905-
Duke University Medical CenterDurhamNorth Carolina27710-
Carolina BioOncology InstituteHuntersvilleNorth Carolina28078-
University of Pittsburgh Medical Center- Hillman Cancer CenterPittsburghPennsylvania15232-
Next OncologyAustinTexas78758-
Mary Crowley Cancer ResearchDallasTexas75230-
Tranquil Clinical ResearchWebsterTexas77598-
NEXT VirginiaFairfaxVirginia22031-

Find similar trials in Phoenix, AZ

By research site
Mayo Clinic Hospital· Phoenix, AZCity of Hope· Duarte, CACalifornia Cancer Associates for Research and Excellence, cCARE· Encinitas, CACity of Hope-Lennar· Irvine, CAUSC/Norris Comprehensive Cancer Center· Los Angeles, CACalifornia Cancer Associates for Research and Excellence, cCARE· San Marcos, CA

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