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XS-02

Phase 1

Solid Tumor | Unknown | Oncology |Co-Diagnostics, Inc.|Last Updated: Aug 1, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment96
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06531486A Study of XS-02 Capsules in Patients With Advanced Solid TumorsPHASE1 NOT YET_RECRUITING 96 — — Jul 29, 2024Aug 30, 2027Aug 1, 2024 - —
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Study Endpoints
Primary Endpoints
Occurrence of Dose Limiting Toxicity (DLT) (DLT observation period).(phase I)
from first dose up to 31 days

DLT is defined as a dose-limiting toxic event that occurs during DLT observation.

Maximum tolerated dose (MTD) and/or Recommended Phase II Dose(RP2D).(phase I)
Time Frame: from first dose to phase I completion, an average of 1.5 years

MTD is defined as the maximum tolerated dose。RP2D is defined as the recommended dose for Phase II clinical studies

Objective Response Rate（ORR）(phase II)
Through study completion, an average of 3 years

ORR is defined as the proportion of patients with confirmed Complete Response (CR) or Partial Response (PR) as evaluated according to RECIST version 1.1.

Secondary Endpoints
the incidence and severity of adverse events, serious adverse events, deaths, and safety screening abnormalities(phase I/II)
From enrollment up to 30 days after last dose
Pharmacokinetics(PK) parameters(phase I/II)
up to 12 weeks
PK parameters(phase I/II)
up to 12 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Phase I dose escalation/Phase II dose expansionEXPERIMENTALExperimental: XS-02 Dosage form:capsule Specification: 5mg，25mg Dose: Phase I dose escalation, orally, once daily, the administration schedule (including dose,administration frequency/interval, administration cycle, etc.) can be adjusted according to the experimental data. Phase II Dose Expansion/Optimal Dose selection, will be determined based on the Phase I dose escalation results. Method of administration: Oral
Interventions
NameTypeDescription
XS-02 capsulesOTHERUpon completion of all screening visits, eligible patients will be treated with XS-02 capsules at the appropriate dose.
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo

inclusion criteria: * Volunteer to participate in clinical trials and sign an informed consent form (ICF). * Age ≥18 years old, ≤75 years old, regardless of gender. * Patients with locally advanced or metastatic solid tumors diagnosed histologically or cytologically have no standard treatment optio...

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Competitive Landscape -Other Solid Tumors 9 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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