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

Recent Changes (Last 90 Days)

LOWJul 28, 2026NCT06150664lastUpdatePostDate: changed
LOWJul 28, 2026NCT06150664lastUpdatePostDate: changed
LOWMay 26, 2026NCT06150664Enrollment: 73 → 85
LOWMay 24, 2026NCT06150664studyFirstPostDate: 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, CTX-8371 is designed to modulate the immune system's response to cancer cells. It is being evaluated in a Phase 1 clinical trial for its safety and efficacy in patients with advanced malignancies.

Who makes CTX-8371?

CTX-8371 is being developed by Compass Therapeutics, Inc., a biopharmaceutical company. Compass Therapeutics is publicly traded under the ticker symbol CMPX. The company is conducting a Phase 1 clinical trial to evaluate CTX-8371 in patients with advanced malignancies.

What phase is CTX-8371 in?

CTX-8371 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial is currently recruiting participants and is designed to evaluate the safety, tolerability, and preliminary efficacy of CTX-8371 in patients with advanced cancers.

What clinical trials is CTX-8371 in?

CTX-8371 is being studied 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 trial has an enrollment target of 85 patients and includes conditions such as Non Small Cell Lung Cancer, Triple Negative Breast Cancer, Hodgkin Lymphoma, Head and Neck Squamous Cell Carcinoma, and Malignant Melanoma.

Is CTX-8371 the same as any other drug?

No, CTX-8371 is a unique investigational drug candidate developed by Compass Therapeutics. It is not known to be the same as any other approved or investigational drug. CTX-8371 is a small molecule that targets PD-L1 and is currently being evaluated in a Phase 1 clinical trial for advanced malignancies.