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CTX-8371

Phase 1

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

CTX-8371 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Nov 2023

CTX-8371 target and mechanism

Molecular targetPD-L1
Target classProtein
ModalityBiologics

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment85

FDA Designations

No designations recorded

CTX-8371 clinical trials

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

Top 20 of 90 competitors

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK39PHASE3Pembrolizumab, Olaparib, Sacituzumab tirumotecan, Intismeran autogene, Pembrolizumab Berahyaluronidase alfa
Revolution Medicines, Inc.RVMD9PHASE3Daraxonrasib, Zoldonrasib, Elironrasib, RMC-5127
Eli Lilly and CompanyLLY18PHASE3Selpercatinib, Pemetrexed, Abemaciclib, Olomorasib, LY3537982
AbbVie, Inc.ABBV12PHASE3Telisotuzumab vedotin, ABBV-1480, Livmoniplimab, Budigalimab, Telisotuzumab Adizutecan
AstraZeneca PLCAZN69PHASE3Datopotamab deruxtecan, Durvalumab, Oleclumab, Monalizumab, Tremelimumab
Gilead Sciences, Inc.GILD7PHASE3Sacituzumab govitecan, Zimberelimab, Domvanalimab, Etrumadenant, TUB-040- Dose escalation
Bristol-Myers Squibb CompanyBMY24PHASE3Repotrectinib, Nivolumab, Pumitamig, Relatlimab, Adagrasib
Johnson & JohnsonJNJ19PHASE3Lazertinib, Amivantamab, JNJ-90301900, JNJ-86974680, Cetrelimab
BioNTech SE Sponsored ADRBNTX7PHASE3Gotistobart, Pumitamig, BNT326, BNT116, BNT324
Pfizer Inc.PFE21PHASE3Lorlatinib, Crizotinib, Avelumab, Talazoparib, Axitinib
Amgen Inc.AMGN4PHASE3ABP 234, Sotorasib, Anvumetostat
Novartis AG Sponsored ADRNVS11PHASE3Opnurasib, TNO155, DKY709, Spartalizumab, KFA115
GSK plc Sponsored ADRGSK3PHASE3Dostarlimab, Belrestotug, Nelistotug, Cobolimab
ArriVent BioPharma, Inc.AVBP9PHASE3Firmonertinib
Summit Therapeutics IncSMMT2PHASE3Ivonescimab
Genmab A/S Sponsored ADRGMAB4PHASE3Acasunlimab, Rina-S, GEN1042
Nuvation Bio, Inc. Class ANUVB4PHASE3Taletrectinib
Regeneron Pharmaceuticals, Inc.REGN7PHASE2Cemiplimab, Marlotamig, Fianlimab, REGN5093
Nuvalent, Inc. Class ANUVL1PHASE3Neladalkib
BeOne Medicines Ltd. Sponsored ADRONC7PHASE3Tislelizumab, BGB-A445, LBL-007, BGB-15025, BGB-43395
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Frequently asked questions about CTX-8371

What is CTX-8371 used for?

CTX-8371 is an investigational small molecule being studied for the treatment of advanced solid tumors and blood cancers, including non small cell lung cancer, triple negative breast cancer, Hodgkin lymphoma, head and neck squamous cell carcinoma, and malignant melanoma. It is not yet approved for any indication and remains in clinical development.

What does CTX-8371 target?

CTX-8371 targets PD-L1, a protein that tumors use to suppress immune responses. By binding to PD-L1, the drug is designed to interfere with this immune checkpoint pathway and allow the immune system to recognize and attack cancer cells. It is a small molecule therapeutic being developed in oncology.

Who is developing CTX-8371?

CTX-8371 is being developed by Compass Therapeutics, Inc., a biopharmaceutical company whose common stock trades on the Nasdaq under the ticker symbol CMPX. The company is the sponsor of the ongoing clinical trial evaluating the drug in patients with advanced malignancies.

What phase is CTX-8371 in?

CTX-8371 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA for any indication. The Phase 1 trial is currently recruiting participants and is designed to evaluate the drug in patients with advanced malignancies.

What clinical trials is CTX-8371 in?

CTX-8371 is being evaluated in one active clinical trial, NCT06150664, titled "A Phase 1 of CTX-8371 in Patients With Advanced Malignancies." The study is recruiting up to 85 participants across sites in the United States and includes patients with non small cell lung cancer, triple negative breast cancer, Hodgkin lymphoma, head and neck squamous cell carcinoma, and malignant melanoma.

Is CTX-8371 biomarker selected?

Yes, the Phase 1 trial of CTX-8371 is biomarker selected, meaning enrollment is guided by specific biological markers. The study is a controlled, non randomized, open label trial that is currently recruiting participants aged 18 years and older, including both male and female patients with advanced malignancies.