XTX301 in Patients With Advanced Solid Tumors

Part of paid clinical trials in Sacramento, California.

Sponsor
Xilio Development, Inc.
Study ID
NCT05684965
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Solid Tumor

Eligibility Criteria

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

Interventions

  • XTX301 — DRUG
    XTX301 monotherapy

Study Details

This is a first-in-human, multicenter, Phase 1/2, open-label study designed to evaluate the safety and tolerability of XTX301 as monotherapy in patients with advanced solid tumors.

Key Dates

Start date
May 11, 2023
Status verified
Aug 2025
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

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

Arms

  • Experimental: Phase 1 - XTX301 Monotherapy Dose Escalation and Pharmacodynamics Expansion
    Part 1A Dose Escalation of XTX301 administered in ascending doses to patients with advanced solid tumors to assess the safety and tolerability and determine/define MTD and/or the highest recommended Phase 2 dose (RP2D). Part 1B Evaluation of XTX301 in patients with selected advanced solid tumors to further characterize the pharmacodynamics profile of XTX301.
  • Experimental: Phase 2 - XTX301 Monotherapy Dose Expansion in Disease-Specific Cohorts
    Phase 2 will further evaluate the safety and antitumor activity/efficacy of XTX301 monotherapy in disease-specific expansion cohorts of patients with select tumors, namely: * Cohort 2A: head and neck squamous cell carcinoma (HNSCC) * Cohort 2B: melanoma (patients with uveal melanoma are excluded) * Cohort 2C: non-small cell lung cancer (NSCLC) * Cohort 2D: ovarian cancer * Cohort 2E: castrate-resistant prostate cancer (CRPC) * Cohort 2F: triple-negative breast cancer (TNBC)

Primary Outcome Measure

Incidence of Dose Limiting Toxicities (DLTs) (Part 1A only) [ Time Frame: From the first dose of the study drug at Cycle 1 Day 1 up to next applicable cycle visit (Cycle 2 Day 1 or Cycle 3 Day 1). Approximately 21 to 42 days. Each cycle is 21 days. ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
University of California, Davis Comprehensive Cancer CenterSacramentoCalifornia95817
Frances Lara
[email protected]
916-734-8134
Yale Cancer CenterNew HavenConnecticut06510
Jialing Zhang, PhD
[email protected]
475-234-9684
HealthPartners Frauenshuh Cancer centerSaint Louis ParkMinnesota55426
Alissa Gavenda
[email protected]
952-993-6705
Washington University School of MedicineSt LouisMissouri63110
Jessica Ley
[email protected]
314-747-8092
Hackensack University Medical CenterHackensackNew Jersey07601
Oncology Clinical Research Referral Office
[email protected]
551-996-1777
The Gabrail Pharmacology Phase 1 Research CenterCantonOhio44718
Carrie Smith, RN
[email protected]
330-417-8231
University Hospital Cleveland Medical CenterClevelandOhio44106
Amit Mahipal, MD
[email protected]
The Ohio State University Wexner Medical CenterColumbusOhio43221
Jacob Nelson
[email protected]
University of Pittsburgh Medical Center-Hillman Cancer CenterPittsburghPennsylvania15232
Julie Urban
[email protected]
412-623-7396
Tranquil Clinical ResearchWebsterTexas77598
Amber Christian
[email protected]
713-907-6054
Medical College of WisconsinMilwaukeeWisconsin53226
Medical College of Wisconsin CCCTO
[email protected]
414-805-8900

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By research site
University of California, Davis Comprehensive Cancer Center· Sacramento, CAYale Cancer Center· New Haven, CTHealthPartners Frauenshuh Cancer center· Saint Louis Park, MNWashington University School of Medicine· St Louis, MOHackensack University Medical Center· Hackensack, NJThe Gabrail Pharmacology Phase 1 Research Center· Canton, OH

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