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

NCT06952010 | Recruiting Phase 1 FDA Drug

• 1 other identifier: XB628-101
• Study Type: interventional
• Target: 303
• Locations: 1 country
• Sites: 11

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Dose Escalation Cohort: Number of Participants with Dose Limiting Toxicities (DLTs)

  21 days

• Dose Escalation Cohort: Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  Up to 27 months

• Dose Expansion Cohort: Objective Response Rate (ORR)

  Up to 27 months

Secondary Outcomes (10)

• Area Under the Concentration-time Curve (AUC) of XB628

  25 months

• Maximum Plasma Concentration (Cmax) of XB628

  25 months

• Time to Maximum Concentration (Tmax) of XB628

  25 months

• Elimination Half-life (T1/2) of XB628

  25 months

• Apparent Clearance (CL/F) of XB628

  25 months

Study Arms (2)

Dose Escalation Phase

EXPERIMENTAL

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.

Biological: XB628; Drug: Zanzalintinib

Dose Expansion

EXPERIMENTAL

Participants with recurrent advanced or metastatic solid tumors will receive XB628 as a single agent and in combination with zanzalintinib.

Biological: XB628; Drug: Zanzalintinib

Interventions

XB628 BIOLOGICAL

Intravenous infusion(s)

Dose Escalation Phase; Dose Expansion

Zanzalintinib DRUG

Oral tablet(s)

Also known as: XL092

Dose Escalation Phase; Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Exelixis: lead

Study Sites (11)

Exelixis Clinical Site #5

San Francisco, California, 94158, United States

RECRUITING

Exelixis Clinical Site #4

New Haven, Connecticut, 06520, United States

RECRUITING

Exelixis Clinical Site #8

Tampa, Florida, 33612, United States

RECRUITING

Exelixis Clinical Site #10

Boston, Massachusetts, 02114, United States

RECRUITING

Exelixis Clinical Site #11

Boston, Massachusetts, 02114, United States

RECRUITING

Exelixis Clinical Site #6

St Louis, Missouri, 63108, United States

RECRUITING

Exelixis Clinical Site #7

New York, New York, 10029, United States

RECRUITING

Exelixis Clinical Site #1

Hickory, North Carolina, 28602, United States

RECRUITING

Exelixis Clinical Site #3

Nashville, Tennessee, 37203, United States

RECRUITING

Exelixis Clinical Site #9

Houston, Texas, 77030, United States

RECRUITING

Exelixis Clinical Site #2

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Medical Director

  Exelixis

  STUDY DIRECTOR

Central Study Contacts

Exelixis Clinical Trials

CONTACT

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

Backup or International

CONTACT

650-837-7400

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: April 30, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)