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CTX-8371

Phase 1

Non Small Cell Lung Cancer | Small molecule | Oncology |Compass Therapeutics, Inc.|Last Updated: Jul 28, 2026

Target and mechanism

Molecular targetPD-L1
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment85

FDA Designations

No designations recorded

Clinical trial landscape

CTX-8371 · 1 trial · 5 indications

Phase 1 1
NCT06150664A Phase 1 of CTX-8371 in Patients With Advanced MalignanciesNon Small Cell Lung Cancer
RECRUITING85 Analytics
PHASE1RECRUITING
A Phase 1 of CTX-8371 in Patients With Advanced Malignancies
Non Small Cell Lung CancerUnlock trial analytics

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 to N/A
SexALL
Healthy VolunteersNo
Study Sites10

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 387 trials (matched to "Non Small Cell Lung Cancer")

Top 20 of 83 competitors

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK24PHASE3Pembrolizumab, Olaparib, Sacituzumab tirumotecan, Pembrolizumab Berahyaluronidase alfa, Intismeran autogene
AstraZeneca PLCAZN62PHASE3Datopotamab deruxtecan, Durvalumab, Oleclumab, Monalizumab, Tremelimumab
Revolution Medicines, Inc.RVMD8PHASE3Daraxonrasib, Elironrasib, Zoldonrasib, RMC-5127
Eli Lilly and CompanyLLY18PHASE3Selpercatinib, Pemetrexed, Abemaciclib, Olomorasib, LY3537982
AbbVie, Inc.ABBV10PHASE3Telisotuzumab vedotin, Telisotuzumab Adizutecan, Livmoniplimab, Budigalimab, ABBV-927
Bristol-Myers Squibb CompanyBMY18PHASE3Repotrectinib, Nivolumab, Pumitamig, Relatlimab, Adagrasib
BioNTech SE Sponsored ADRBNTX7PHASE3Gotistobart, Pumitamig, BNT326, BNT116, BNT324
Gilead Sciences, Inc.GILD4PHASE3Sacituzumab govitecan, Zimberelimab, Domvanalimab, Etrumadenant
Pfizer Inc.PFE16PHASE3Lorlatinib, Crizotinib, Avelumab, Talazoparib, Axitinib
Johnson & JohnsonJNJ17PHASE3Lazertinib, Amivantamab, JNJ-90301900, JNJ-86974680, Cetrelimab
ArriVent BioPharma, Inc.AVBP9PHASE3Firmonertinib
Amgen Inc.AMGN4PHASE3ABP 234, Sotorasib, Anvumetostat
Novartis AG Sponsored ADRNVS9PHASE3Opnurasib, TNO155, DKY709, Spartalizumab, trametinib
GSK plc Sponsored ADRGSK3PHASE3Dostarlimab, Belrestotug, Nelistotug, Cobolimab
Summit Therapeutics IncSMMT2PHASE3Ivonescimab
Nuvation Bio, Inc. Class ANUVB4PHASE3Taletrectinib
Genmab A/S Sponsored ADRGMAB4PHASE3Acasunlimab, Rina-S, GEN1042
Regeneron Pharmaceuticals, Inc.REGN6PHASE2Cemiplimab, Marlotamig, Fianlimab, REGN5093
BeOne Medicines Ltd. Sponsored ADRONC6PHASE3Tislelizumab, BGB-A445, LBL-007, BGB-15025, BGB-43395
BeyondSpring Inc.BYSI1PHASE3Plinabulin
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Recent Changes (Last 90 Days)

LOWJul 28, 2026NCT06150664lastUpdatePostDate: changed
LOWJul 28, 2026NCT06150664lastUpdatePostDate: changed

Frequently asked questions about CTX-8371

What is CTX-8371 used for?

CTX-8371 is an investigational small molecule being developed for the treatment of Non Small Cell Lung Cancer. It is currently in Phase 1 clinical development and is also being studied in other advanced malignancies including Triple Negative Breast Cancer, Hodgkin Lymphoma, Head and Neck Squamous Cell Carcinoma, and Malignant Melanoma.

What does CTX-8371 target?

CTX-8371 targets PD-L1, a protein involved in immune checkpoint regulation. By targeting PD-L1, the drug is designed to modulate the immune system's response to cancer cells. This mechanism is being evaluated in a Phase 1 clinical trial for patients with advanced malignancies.

Who makes CTX-8371?

CTX-8371 is being developed by Compass Therapeutics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol CMPX. The company is currently conducting a Phase 1 clinical trial to evaluate the safety and efficacy of this investigational drug.

What phase is CTX-8371 in?

CTX-8371 is in Phase 1 clinical development. It is an investigational drug that has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is actively recruiting patients to assess the drug's safety, tolerability, and preliminary efficacy in advanced malignancies.

What clinical trials is CTX-8371 in?

CTX-8371 is being evaluated in a Phase 1 clinical trial with the identifier NCT06150664. This trial is titled 'A Phase 1 of CTX-8371 in Patients With Advanced Malignancies' and is currently recruiting participants in the United States. The study aims to enroll 85 patients aged 18 years and older.

Is CTX-8371 the same as other PD-L1 inhibitors?

CTX-8371 is a distinct investigational small molecule that targets PD-L1. While it shares a similar molecular target with other PD-L1 inhibitors, it is a unique drug candidate developed by Compass Therapeutics. Its specific chemical structure and properties differentiate it from other agents in this class.