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TGRX-326

Phase 1

Non-small Cell Lung Cancer | Small molecule | Oncology |Co-Diagnostics, Inc.|Last Updated: May 18, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment198
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05441956TGRX-326 Chinese Phase I for Advanced Non-small Cell Lung Cancer (NSCLC)PHASE1 ACTIVE NOT_RECRUITING 198 — — Apr 23, 2021Oct 31, 2025May 18, 20251 China
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Study Endpoints
Primary Endpoints
Maximal tolerated dose (MTD)
At end of Cycle 1 (each cycle is 21 days) when the probability of DLT of a dose level is higher than 33%

To determine the MTD of TGRX-326 in NSCLC patients

Recommended phase II dose (RP2D)
At completion of the dose expansion study, an average of 1 year

To determine the RP2D of TGRX-326 in NSCLC patients for Phase II

Safety profile (DLT)
Collect during Cycle 1 (each cycle is 21 days)

To record and analyse subjects with dose-limiting toxicities (DLTs)

Safety profile (AEs/SAEs)
Through completion of the study, an average of 1.5 years

To record and analyse subjects with adverse events (AEs) and serious adverse events (SAEs)

Secondary Endpoints
Plasma Cmax
Day1/3 of single-dose period; Day1/8/15 of Cycle 1; Day1 of Cycle 2-5, Day 1 of every other cycle starting from Cycle 7; Day 1 of every 4 cycles starting from Cycle 17 (each cycle is 21 days)
Plasma Tmax
Day1/3 of single-dose period; Day1/8/15 of Cycle 1; Day1 of Cycle 2-5, Day 1 of every other cycle starting from Cycle 7; Day 1 of every 4 cycles starting from Cycle 17 (each cycle is 21 days)
T1/2
Day1/3 of single-dose period; Day1/8/15 of Cycle 1; Day1 of Cycle 2-5, Day 1 of every other cycle starting from Cycle 7; Day 1 of every 4 cycles starting from Cycle 17 (each cycle is 21 days)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TGRX-326EXPERIMENTALSubjects to be treated with the investigational drug TGRX-326
Interventions
NameTypeDescription
TGRX-326DRUGParticipants are given TGRX-326 tablets orally at one of the dose levels as pre-determined.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Willing to follow the treatment protocol and visit schedule, and participate in the study with the ICF signed; * ≥ 18 years of age on the day of ICF signing, regardless of gender. * Diagnosis of ALK-positive or ROS1-positive advanced NSCLC by histopathology or cytology in a Gr...

Countries:China
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Competitive Landscape -Non-Small Cell Lung Cancer 406 trials
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Revolution Medicines, Inc.RVMD8PHASE3daraxonrasib, docetaxel, RMC-6291, Elironrasib, Daraxonrasib
Eli Lilly and CompanyLLY19PHASE3Selpercatinib, Carboplatin, Cisplatin, Pemetrexed, Pembrolizumab
AbbVie, Inc.ABBV10PHASE3Telisotuzumab Vedotin, Docetaxel, Telisotuzumab vedotin, Telisotuzumab Adizutecan, Livmoniplimab
Bristol-Myers Squibb CompanyBMY20PHASE3Repotrectinib, Crizotinib, Nivolumab, Carboplatin, Cisplatin
BioNTech SE Sponsored ADRBNTX7PHASE3Gotistobart, Docetaxel, PM8002, Carboplatin, Pemetrexed
Gilead Sciences, Inc.GILD4PHASE3Sacituzumab Govitecan-hziy, Docetaxel, Zimberelimab, Domvanalimab, Pembrolizumab
GSK plc Sponsored ADRGSK4PHASE3Cobolimab, Dostarlimab, Docetaxel, Belrestotug, Pembrolizumab
Johnson & JohnsonJNJ18PHASE3Lazertinib, Amivantamab, Pemetrexed, Carboplatin, Osimertinib
Pfizer Inc.PFE21PHASE3Lorlatinib, Crizotinib, Avelumab, Lorlatanib, Talazoparib
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Novartis AG Sponsored ADRNVS9PHASE3JDQ443, docetaxel, TNO155, tislelizumab, DKY709
Summit Therapeutics IncSMMT2PHASE3Ivonescimab, Pembrolizumab
Nuvation Bio, Inc. Class ANUVB4PHASE3Taletrectinib, Crizotinib, AB-106
Genmab A/S Sponsored ADRGMAB4PHASE3Acasunlimab, Pembrolizumab, Docetaxel, Rina-S, GEN1042
Incyte CorporationINCY1PHASE3Retifanlimab, Pemetrexed, Cisplatin, Carboplatin, Paclitaxel
Regeneron Pharmaceuticals, Inc.REGN6PHASE2cemiplimab, Platinum Doublet, fianlimab, Pemetrexed, Paclitaxel
BeOne Medicines Ltd. Sponsored ADRONC6PHASE3Tislelizumab, Cisplatin, Paclitaxel, Pemetrexed Disodium, Carboplatin
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