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Recruiting NCT06952010

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

Phase I Interventional Solid Tumor Advanced Solid Tumor Metastatic Solid Tumor Immune Sensitive Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: XB628, Zanzalintinib.
Who it may be relevant to
Registry conditions: Solid Tumor, Advanced Solid Tumor, Metastatic Solid Tumor, Immune Sensitive Tumor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1 Dose Escalation and Expansion Study of XB628 as a Single Agent and in Combination With Zanzalintinib in Participants With Advanced or Metastatic Solid Tumors

Overview

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.

Interventions

  • Biological XB628
    Intravenous infusion(s)
  • Drug Zanzalintinib
    Oral tablet(s)

Primary outcome measures

  • 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]
Secondary outcome measures (10)
  • Area Under the Concentration-time Curve (AUC) of XB628 [Time frame: 25 months]
  • Maximum Plasma Concentration (Cmax) of XB628 [Time frame: 25 months]
  • Time to Maximum Concentration (Tmax) of XB628 [Time frame: 25 months]
  • Elimination Half-life (T1/2) of XB628 [Time frame: 25 months]
  • Apparent Clearance (CL/F) of XB628 [Time frame: 25 months]
  • Trough Concentration (Ctrough) of XB628 [Time frame: 25 months]
  • Number of Participants with Antidrug Antibody (ADA) Response to XB628 [Time frame: 25 months]
  • RDE for XB628 [Time frame: 25 months]
  • Dose Expansion Cohort: Duration of Response (DOR) [Time frame: 27 months]
  • Dose Expansion Cohort: Progression-Free Survival (PFS) of XB628 [Time frame: 27 months]

Eligibility criteria

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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 11 centers
  • Exelixis Clinical Site #5 — San Francisco
  • Exelixis Clinical Site #4 — New Haven
  • Exelixis Clinical Site #8 — Tampa
  • Exelixis Clinical Site #10 — Boston
  • Exelixis Clinical Site #11 — Boston
  • Exelixis Clinical Site #6 — St Louis
  • Exelixis Clinical Site #7 — New York
  • Exelixis Clinical Site #1 — Hickory
  • … and 3 more centers

Identifiers

NCT: NCT06952010 · XB628-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗