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CTX-8371

Phase 1

Non Small Cell Lung Cancer | Small molecule | Oncology |Compass Therapeutics, Inc.|Last Updated: Apr 20, 2026

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment85
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06150664A Phase 1 of CTX-8371 in Patients With Advanced MalignanciesPHASE1 RECRUITING 85 — — Mar 19, 2024May 1, 2027Apr 20, 20269 United States
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Study Endpoints
Primary Endpoints
Cohort 1: Evaluate the safety and tolerability of escalating doses of CTX-8371
From first dose of CTX-8371 (Cycle 1 Day 1, Cycle = 2 weeks) until 30 days after the last dose of CTX-8371, average of 6 months

Number of participants with dose limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities

Cohort 1: Determine the dose(s) of CTX-8371 to be further examined in Cohort 2 and Phase 2 studies
From first dose of CTX-8371 (Cycle 1 Day 1, Cycle = 2 weeks ) until 30 days after the last dose of CTX-8371 (average of 6 months )
Cohort 2: Evaluate the safety and tolerability of CTX-8371 at 3.0 mg/kg and 10.0 mg/kg
From first dose of CTX-8371 (Cycle 1 Day 1, Cycle = 2 weeks) until 30 days after the last dose of CTX-8371 (up to 2 years)

Incidence of treatment-emergent adverse events (TEAEs)

Secondary Endpoints
Cohort 1 and 2: Objective Response Rate (ORR) (Percentage of Participants With Objective Response) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Baseline until confirmed disease progression (up to 2 years)
Cohort 1 and 2: Duration of Response (DOR) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
From the date of first confirmed CR or PR until the first date of recurrent or progressive disease (up to 2 years)
Cohort 1 and 2: Progression-Free Survival (PFS) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
From first dose of CTX-8371(Cycle 1 Day 1,Cycle = 2 weeks ) until disease progression or death, whichever occur first (up to 2 years)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose Escalation Cohort 1EXPERIMENTALEscalating doses of CTX-8371
Dose Expansion Cohort 2EXPERIMENTALTwo CTX-8371 dose groups (3.0 mg/kg and 10.0 mg/kg) in three tumor type subgroups (NSCLC, TNBC, and HL)
Interventions
NameTypeDescription
CTX-8371DRUGIntravenous (IV) infusion every two weeks.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: 1. Age 18 years or older 2. Patients must have a histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic disease that is relapsed/refractory to standard therapy or for which no effective standard therapy is available, including 1. M...

Countries:United States
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Competitive Landscape -Non-Small Cell Lung Cancer 406 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK25PHASE3Pembrolizumab, Olaparib, Etoposide, Carboplatin, Cisplatin
Amgen Inc.AMGN5PHASE3AMG 510, Docetaxel, ABP 234, Pembrolizumab, Sotorasib
AstraZeneca PLCAZN63PHASE3Datopotamab deruxtecan, Durvalumab, Carboplatin, Pembrolizumab, Cisplatin
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
ArriVent BioPharma, Inc.AVBP9PHASE3Firmonertinib, Drug: Furmonertinib, Furmonertinib, JAB-21822, JAB 21822
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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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06150664Enrollment: 73 → 85
LOWMay 24, 2026NCT06150664studyFirstPostDate: changed