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XB371

Phase 1

Solid Tumors | Small molecule | Oncology |Exelixis, Inc.|Last Updated: Feb 17, 2026

Target and mechanism

Molecular targetTF
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment150

FDA Designations

No designations recorded

Clinical trial landscape

XB371 · 1 trial · 1 indication

Phase 1 1
NCT07123103A Study of XB371 Administered in Participants With Locally Advanced or Metastatic Solid TumorsSolid Tumors
RECRUITING150 Analytics
PHASE1RECRUITING
A Study of XB371 Administered in Participants With Locally Advanced or Metastatic Solid Tumors
Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants with a Dose-limiting Toxicity (DLT)
Up to the end of the first cycle (Up to Day 21 of a 21-day cycle)
Number of Participants with a Treatment-emergent Adverse Event (TEAE)
Up to approximately 7 months

Secondary Endpoints

Area Under the Plasma Concentration-time Curve (AUC) of XB371, Total Antibody and Unconjugated Belotecan
Up to approximately 7 months
Maximum Observed Plasma Concentration (Cmax) of XB371, Total Antibody and Unconjugated Belotecan
Up to approximately 7 months
Time to Maximum Observed Plasma Concentration (Tmax) of XB371, Total Antibody and Unconjugated Belotecan
Up to approximately 7 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose-escalation CohortsEXPERIMENTALParticipants will receive escalating doses of XB371 every 3 weeks of a 21-day cycle (alternate schedules may be evaluated) until meeting the criteria for treatment discontinuation.
Dose-expansion Cohorts: Part AEXPERIMENTALParticipants with Tumor Type 1 (tumor type will be selected based on available data) will be randomized to receive XB371 at one of two recommended dose levels (recommended dose \[RD\]-1 or RD-2) every 3 weeks of a 21-day cycle (alternate schedules may be evaluated) until meeting the criteria for treatment discontinuation.
Dose-expansion Cohorts: Part BEXPERIMENTALParticipants with Tumor Type 2 (tumor type will be selected based on available data) will receive XB371 at the recommended dose level every 3 weeks of a 21-day cycle (alternate schedules may be evaluated) until meeting the criteria for treatment discontinuation.

Interventions

NameTypeDescription
XB371DRUGIntravenous (IV) infusion.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites9

Key Inclusion Criteria: * 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. Key Exclusion Criteria: * Primary brain tumors or know...

Countries:United States
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumors")

Frequently asked questions about XB371

What is XB371 used for in solid tumors?

XB371 is an investigational small molecule being studied for the treatment of locally advanced or metastatic solid tumors. It is currently in Phase 1 clinical development, and its safety and efficacy have not yet been established.

What does XB371 target?

XB371 targets TF, a protein involved in tumor biology. By targeting this protein, the drug aims to interfere with pathways that may contribute to tumor growth and progression, though its exact mechanism is still under investigation.

Who makes XB371?

XB371 is being developed by Exelixis, Inc., a biopharmaceutical company. The company is conducting a Phase 1 clinical trial to evaluate the drug in patients with solid tumors.

What phase is XB371 in?

XB371 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being tested for safety and efficacy in clinical trials.

What clinical trials is XB371 in?

XB371 is being studied in a Phase 1 clinical trial with the identifier NCT07123103. This trial is recruiting participants with locally advanced or metastatic solid tumors and is being conducted in the United States.