Recruiting
Phase 1

XB628

Sponsor:

Exelixis

Code:

NCT06952010

Conditions

Solid Tumor

Advanced Solid Tumor

Metastatic Solid Tumor

Immune Sensitive Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

XB628

Zanzalintinib

Study Details

Brief summary:

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.

Conditions

Solid Tumor

Advanced Solid Tumor

Metastatic Solid Tumor

Immune Sensitive Tumor

Study ID

NCT06952010

Start date

May 1, 2025

Status verified date

Jun, 2026

Completion date

Nov 30, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  • Minimum life expectancy of ≥ 12 weeks.
  • Have a recurrent advanced or metastatic solid tumor that is histologically or cytologically confirmed.
  • Adequate organ and marrow function.
  • Not amenable to curative treatment with surgery or radiation.
  • Received at least 1 line of prior systemic anticancer therapy in the recurrent or metastatic setting.
  • Acceptable alternative therapy was received, refused, intolerable, or no longer effective.
  • Capable of understanding and complying with the protocol requirements and provide signed informed consent according to the protocol and local requirements.

Key Exclusion Criteria

  • Primary brain tumors or known active brain metastases.
  • Major surgery (eg, gastrointestinal surgery, removal or biopsy of brain metastasis) within 4 weeks before the first dose of study treatment.
  • Received radiation therapy within 1 week before the first dose of study treatment or clinically relevant ongoing complications from prior radiation therapy.
  • Received prior therapy targeting NK cells (eg, monalizumab).
  • A woman of childbearing potential has a positive serum pregnancy test within 7 days prior to study treatment.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Enrollment

303 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

XB628

Intravenous infusion(s)

Zanzalintinib

Oral tablet(s)

Primary outcome measure

  • Dose Escalation Cohort: Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: 21 days ]
  • Dose Escalation Cohort: Number of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to 27 months ]
  • Dose Expansion Cohort: Objective Response Rate (ORR) [ Time Frame: Up to 27 months ]

Central Contacts and Locations

Central contacts

Exelixis Clinical Trials

1-888-EXELIXIS (888-393-5494)druginfo@exelixis.com

Backup or International

650-837-7400

Locations

Exelixis Clinical Site #5

Recruiting

San Francisco, California, United States, 94158

Exelixis Clinical Site #4

Recruiting

New Haven, Connecticut, United States, 06520

Exelixis Clinical Site #8

Recruiting

Tampa, Florida, United States, 33612

Exelixis Clinical Site #10

Recruiting

Boston, Massachusetts, United States, 02114

Exelixis Clinical Site #11

Recruiting

Boston, Massachusetts, United States, 02114

Exelixis Clinical Site #6

Recruiting

St Louis, Missouri, United States, 63108

Exelixis Clinical Site #7

Recruiting

New York, New York, United States, 10029

Exelixis Clinical Site #1

Recruiting

Hickory, North Carolina, United States, 28602

Exelixis Clinical Site #3

Recruiting

Nashville, Tennessee, United States, 37203

Exelixis Clinical Site #9

Recruiting

Houston, Texas, United States, 77030

Exelixis Clinical Site #2

Recruiting

San Antonio, Texas, United States, 78229

More Information

Sponsor

Exelixis

Last update posted

Jun 24, 2026

Last verified

Jun, 2026

Keywords

  • XB628
  • Solid tumor
  • Advanced solid tumor
  • Metastatic solid tumor
  • Immune sensitive tumor
  • PD-L1
  • Zanzalintinib

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Exelixis on 2026-06-24.