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ZG005

Phase 1

Advanced Solid Tumor | Small molecule | Oncology |Co-Diagnostics, Inc.|Last Updated: Aug 27, 2025

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment153
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07142837Study of ZG005 in Combination With Gecacitinib and Chemotherapy for Participants With Advanced Solid TumorsPHASE1 NOT YET_RECRUITING 153Sep 1, 2025Dec 1, 2027Aug 27, 20251 China
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Study Endpoints
Primary Endpoints
Dose Limiting Toxicity (DLT)
During the first 28 days
Objective Response Rate (ORR)
Up to 2 years
Adverse events (AEs)
Up to 2 years
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1: Dose EscalationEXPERIMENTALDose-escalation study of ZG005 in combination with Gecacitinib and Chemotherapy.
Part 2: Dose ExpansionEXPERIMENTALCohort A: HER2-negative gastric or gastroesophageal junction adenocarcinoma; Cohort B: Esophageal squamous cell carcinoma; Cohort C: other Solid Tumors.
Interventions
NameTypeDescription
ZG005DRUGZG005 20mg/kg; once every 3 weeks;IV infusion
GecacitinibDRUGGecacitinib for dose escalations are set as 100mg Bid po. Gecacitinib for dose expansion will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose-escalation stage.
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Fully understand the study and voluntarily sign the informed consent form. * Male or female 18-75 years of age. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1. * PART 1: Histologically confirmed unresectable locally advanced, recurrent, or metastatic sol...

Countries:China
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT07142837studyFirstPostDate: changed