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A Study of XB371 Administered in Participants With Locally Advanced or Metastatic Solid Tumors

ConditionSolid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorExelixis

About this trial

The primary purpose of the study is to characterize the safety and tolerability of XB371. The dose-escalation cohorts and Part B of the expansion cohorts are non-randomized. Part A of the expansion cohorts is randomized.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

Minimum life expectancy of ≥ 12 weeks.

Recurrent locally advanced or metastatic solid tumors.

Adequate end organ and bone marrow function.

Disqualifiers

Primary brain tumors or known active brain metastases, leptomeningeal, or cranial epidural disease.

History of interstitial lung disease (ILD) of any grade or history of organizing pneumonia.

Has acute ocular infection, acute or chronic ulcerative/cicatricial condition of conjunctiva or cornea.

Known history of immunodeficiency virus (HIV) unless specific criteria are met.

Trial design

Design model

Sequential

Treatments tested in this trial

  • XB371

    Drug

    Intravenous (IV) infusion.

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: Dose-escalation CohortsExperimental treatment 1 intervention
Group B: Dose-expansion Cohorts: Part AExperimental treatment 1 intervention
Group C: Dose-expansion Cohorts: Part BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants with a Dose-limiting Toxicity (DLT)

Time frame
Up to the end of the first cycle (Up to Day 21 of a 21-day cycle)
2

Number of Participants with a Treatment-emergent Adverse Event (TEAE)

Time frame
Up to approximately 7 months

Secondary outcomes

1

Area Under the Plasma Concentration-time Curve (AUC) of XB371, Total Antibody and Unconjugated Belotecan

Time frame
Up to approximately 7 months
2

Maximum Observed Plasma Concentration (Cmax) of XB371, Total Antibody and Unconjugated Belotecan

Time frame
Up to approximately 7 months
3

Time to Maximum Observed Plasma Concentration (Tmax) of XB371, Total Antibody and Unconjugated Belotecan

Time frame
Up to approximately 7 months
4

Trough Observed Plasma Concentration (Ctrough) of XB371, Total Antibody and Unconjugated Belotecan

Time frame
Up to approximately 7 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Exelixis

Lead sponsor

Source ClinicalTrials.gov
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