A Study of XB628 Alone and in Combination With Zanzalintinib in Participants With Recurrent Advanced or Metastatic Solid Tumors

Part of paid clinical trials in San Francisco, California.

Sponsor
Exelixis
Study ID
NCT06952010
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumor
  • Immune Sensitive Tumor
  • Metastatic Solid Tumor
  • Solid Tumor

Eligibility Criteria

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

Interventions

  • XB628 — BIOLOGICAL
    Intravenous infusion(s)
  • Zanzalintinib — DRUG
    Oral tablet(s)

Study Details

This study consists of a Dose-Escalation stage and a Dose Expansion stage. The primary purpose of the dose escalation stage is to determine the maximum tolerated dose (MTD) and/or recommended dosage(s) for expansion (RDE\[s\]); and the dose expansion stage is to evaluate the preliminary antitumor activity of XB628 as a single agent and in combination with zanzalintinib.

Key Dates

First listed
Apr 30, 2025
Start date
May 1, 2025
Status verified
Jun 2026
Primary completion
May 31, 2027
Completion
Nov 30, 2027

Study Design

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

Arms

  • Experimental: Dose Escalation Phase
    Participants with recurrent advanced or metastatic solid tumors will receive escalating dose levels doses of XB628 as a single agent and in combination with zanzalintinib.
  • Experimental: Dose Expansion
    Participants with recurrent advanced or metastatic solid tumors will receive XB628 as a single agent and in combination with zanzalintinib.

Primary Outcome Measure

Dose Escalation Cohort: Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: 21 days ]

Central Contacts

  • Exelixis Clinical Trials
    1-888-EXELIXIS (888-393-5494)
    [email protected]
  • Backup or International
    650-837-7400

Locations (11)

FacilityCityStateZIPSite coordinators
Exelixis Clinical Site #5San FranciscoCalifornia94158-
Exelixis Clinical Site #4New HavenConnecticut06520-
Exelixis Clinical Site #8TampaFlorida33612-
Exelixis Clinical Site #10BostonMassachusetts02114-
Exelixis Clinical Site #11BostonMassachusetts02114-
Exelixis Clinical Site #6St LouisMissouri63108-
Exelixis Clinical Site #7New YorkNew York10029-
Exelixis Clinical Site #1HickoryNorth Carolina28602-
Exelixis Clinical Site #3NashvilleTennessee37203-
Exelixis Clinical Site #9HoustonTexas77030-
Exelixis Clinical Site #2San AntonioTexas78229-

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