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

Phase
Recruitment status
Participants
Lead sponsor
Start date
Number of sites

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

Control arm
Registry reports results
Listing at source
Recruitment status
Phase
Study type
Interventional

Completion date
First posted
Registry last updated
Primary completion date
Start date

Participants
Participant count basis
Planned participants
Protocol amendments
Number of sites

Data monitoring committee
Registry sponsor category
Lead sponsor
Source registry
ClinicalTrials.gov

Registry ID
ClinicalTrials.gov ID
Registry record
Open registry record

Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design

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

    Timeframe: 21 days

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

    Timeframe: Up to 27 months

  3. Dose Expansion Cohort: Objective Response Rate (ORR)

    Timeframe: Up to 27 months

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

    Timeframe: 25 months

  2. Maximum Plasma Concentration (Cmax) of XB628

    Timeframe: 25 months

  3. Time to Maximum Concentration (Tmax) of XB628

    Timeframe: 25 months

  4. Elimination Half-life (T1/2) of XB628

    Timeframe: 25 months

  5. Apparent Clearance (CL/F) of XB628

    Timeframe: 25 months

  6. Trough Concentration (Ctrough) of XB628

    Timeframe: 25 months

  7. Number of Participants with Antidrug Antibody (ADA) Response to XB628

    Timeframe: 25 months

  8. RDE for XB628

    Timeframe: 25 months

  9. Dose Expansion Cohort: Duration of Response (DOR)

    Timeframe: 27 months

  10. Dose Expansion Cohort: Progression-Free Survival (PFS) of XB628

    Timeframe: 27 months

Sources for outcomes

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

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.

Sources for eligibility

  • Exelixis Clinical Site #5San Francisco, United StatesRecruiting
  • Exelixis Clinical Site #4New Haven, United StatesRecruiting
  • Exelixis Clinical Site #8Tampa, United StatesRecruiting
  • Exelixis Clinical Site #10Boston, United StatesRecruiting
  • Exelixis Clinical Site #11Boston, United StatesRecruiting
  • Exelixis Clinical Site #6St Louis, United StatesRecruiting
  • Exelixis Clinical Site #7New York, United StatesRecruiting
  • Exelixis Clinical Site #1Hickory, United StatesRecruiting
  • Exelixis Clinical Site #3Nashville, United StatesRecruiting
  • Exelixis Clinical Site #9Houston, United StatesRecruiting
  • Exelixis Clinical Site #2San Antonio, United StatesRecruiting
Sources for sites

Related records

Drugs (1)

Lead sponsors (1)