Non Small Cell Lung CancerPhase 1NCT06150664

A Phase 1 of CTX-8371 in Patients With Advanced Malignancies

A Phase 1 study testing CTX-8371 in people with Non Small Cell Lung Cancer and Triple Negative Breast Cancer, run by Compass Therapeutics at 12 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

This is a Phase 1, open-label, first-in-human study of CTX-8371 administered as a monotherapy in patients with metastatic or locally advanced malignancies. The study will be conducted in 2 cohorts: Dose Escalation and Dose Expansion. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non Small Cell Lung Cancer, Triple Negative Breast Cancer, Hodgkin Lymphoma
What is being tested?: CTX-8371
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 85 participants
Where: 12 sitesUnited States
Study dates: 19 Mar 2024to May 2027
Phase: Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18 years or older
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
Malignant Melanoma (MM)
Patients who have progressed after a minimum of 2 doses of a PD-1/PD-L1 treatment. Study enrollment (C1D1) must be within 12 weeks of the last dose of the anti-PD-1/PD-L1 blocking antibody
Patients must have had prior testing for BRAF V600 mutations. Patients with BRAF V600 activating mutation must have received prior therapy with a BRAF/MEK inhibitor
Uveal and mucosal melanoma are excluded

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Head and Neck squamous cell carcinoma (HNSCC)
HNSCC of oral cavity, oropharynx, hypopharynx, or larynx
Patients who have progressed after a minimum of 2 doses of a PD-1/PD-L1 treatment. Study enrollment (C1D1) must be within 12 weeks of the last dose of the anti-PD-1/PD-L1 blocking antibody
Patients must have received prior treatment with platinum-based chemotherapy
Non-Small Cell Lung Cancer (NSCLC)
Patients who have progressed after a minimum of 2 doses of a PD-1/PD-L1 treatment. Study enrollment (C1D1) must be within 12 weeks of the last dose of the anti-PD-1/PD-L1 blocking antibody
Patients must have received prior treatment with platinum-based chemotherapy
Triple Negative Breast Cancer (TNBC)
ER/PR and HER2 status should be defined by ASCO/CAP guidelines (JCO Allison et al 2020)
Patients with HER2-low cancers (HER2 IHC 1+ or 2+/ISH negative) are excluded
Patients must have received prior sacituzumab govitecan and if PD-L1 ≥10% by CPS pembrolizumab with chemotherapy
Classical Hodgkin Lymphoma (HL)
Patients must have received at least two prior systemic therapies including brentuximab vedotin (if eligible) and a prior PD-1 inhibitor
Patients must have experienced less than a CR (according to Lugano criteria) to anti- PD-1 treatment
(Cohort 2 Dose Expansion): Non-Small Cell Lung Cancer (NSCLC)
Patients who have progressed after a minimum of 2 doses of a PD-1/PD-L1 treatment
Patients must have received prior treatment with platinum-based chemotherapy
(Cohort 2 Dose Expansion) Triple Negative Breast Cancer (TNBC)
ER/PR and HER2 status should be defined by ASCO/CAP guidelines (JCO Allison et al 2020)
Patients must have received prior sacituzumab govitecan and if PD-L1 ≥10% by CPS pembrolizumab with chemotherapy
Patients with HER2-low tumors (HER2 IHC 1+ or 2+/ISH negative) need to have received fam-trastuzumab deruxtecan (Enhertu)
(Cohort 2 Dose Expansion) Classical Hodgkin's Lymphoma (HL)
Patients must have received at least two prior systemic therapies including brentuximab vedotin (if eligible) and a prior PD-1 inhibitor.
Patients must have received at least 12 weeks of treatment with a PD-1/PD-L1 inhibitor as a monotherapy or in combination and had at least stable disease or progressive disease (PD) with overall clinical benefit.
Patients with NSCLC, MM, TNBC, and HNSCC must have measurable disease per RECIST 1.1. Patients with HL must have at least one measurable lesion > 1.5 cm for nodal, > 1.0 cm for extranodal FDG-avid disease by the Lugano (2014) response criteria. Tumor sites that are considered measurable must not have received prior radiation
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Adequate bone marrow function defined by absolute neutrophil (ANC) of ≥ 1.5×109/L, platelet count of ≥ 100.0×109/L, and hemoglobin of ≥ 9.0 g/dL (with or without transfusion)
(Cohort 2 Dose Expansion) Adequate bone marrow function defined by absolute neutrophil (ANC) of ≥ 1.5×109/L, platelet count of ≥ 100.0×109/L, and hemoglobin of ≥ 9.0 g/dL (with or without transfusion) within 2 weeks from the first dose of CTX-8371.
Blood transfusion is not allowed within 2 weeks from the first dose of CTX-8371
Adequate hepatic function defined as serum total bilirubin ≤ 1.5 × ULN, AST/ALT ≤ 2.5 × ULN (or ≤ 5 × ULN in patients with liver metastases)
Adequate renal function defined as creatinine clearance ≥ 30mL/min by Cockcroft-Gault equation
Female patients must be surgically sterile (or have a monogamous partner who is surgically sterile) or be at least 2 years postmenopausal or commits to use 2 acceptable forms of birth control (defined as the use of an intrauterine device (IUD), a barrier method with spermicide, condoms, any form of hormonal contraceptives) or abstinence for the duration of the study and for 4 months following the last dose of study treatment. Male patients must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control (condoms with spermicide) for the duration of the study and for 4 months following the last dose of study treatment
Female patients who are women of childbearing potential (WOCBP) must have a negative serum pregnancy test at Screening within 7 days of dosing with CTX-8371
Last dose of previous PD-1 or PD-L1 therapy ≥ 28 days, other anticancer therapy > 21 days (or 2 half-lives for proteins, whichever is longer), radiotherapy >21 days (concurrent localized palliative radiotherapy is allowed during CTX-8371 treatment), or surgical intervention >21 days prior to the first dose of CTX-8371
Resolution of all prior anti-cancer therapy toxicities ≤ Grade 2
Life expectancy ≥ 12 weeks
Capable of understanding and complying with protocol requirements
Signed and dated institutional review board (IRB)/independent ethics committee (IEC)-approved informed consent form (ICF) before any protocol-directed screening procedures are performed

Who cannot join

Developed clinically significant adverse reaction to PD-1 or PD-L1 therapy, including immune related adverse reactions, which led to discontinuation of treatment
Systemic therapy with immunosuppressive agents within 7 days before the start of CTX-8371 treatment. Topical, intranasal, intraocular, or inhaled corticosteroids and physiologic replacement for patients with adrenal insufficiency are allowed
Patient is a pregnant or lactating WOCBP
Prior organ transplantation
Patients with evidence of active hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection. Patients with positive HBsAg and/or detectable HBV DNA are eligible only if adequately controlled on antiviral therapy according to institutional standards and liver function eligibility criteria are also met. HCV patients showing sustained viral response or patients with immunity to HBV infection may enroll.
Active autoimmune disease or medical conditions requiring chronic steroid (i.e., > 10 mg/day prednisone or equivalent) or immunosuppressive therapy. Patients with a prior history of autoimmune disease may be eligible following discussion with the Medical Monitor

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History of primary malignancy other than the malignancy under study will be excluded, except for malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate >90%). Prior malignancy history will be evaluated on a case-by-case basis by the Sponsor Medical Monitor.
Symptomatic or uncontrolled central nervous system and brain metastasis or active leptomeningeal disease. Patients with equivocal findings or with confirmed brain metastases are eligible for the study provided that they are asymptomatic and radiologically and neurologically stable without the need for corticosteroid treatment or seizure prophylaxis for ≥4 weeks before the first dose of study drug. Prior treatment with either surgery or radiation is permitted and all patients with a history of CNS or brain lesions require imaging during screening to confirm stability.
Other medical condition that in the opinion of the Investigator and/or Sponsor Medical Monitor may interfere with the conduct and/or interpretation of the current study, including:
Congestive heart failure (> New York Heart Association Class II), active coronary artery disease, unevaluated new onset angina within 3 months or unstable angina (angina symptoms at rest) or clinically significant cardiac arrhythmias
QTc interval (using Fridericia correction calculation) > 480 msec

Trial locations and contacts

12 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Natalie Warholic contact

617-500-8099

CTX-8371-001@compasstherapeutics.com

City, postcode or hospital

Sites recruiting now only

12 sites in 1 country

United States12 sites, 11 recruiting

University Cancer & Blood Center
Athens, Georgia, 30607
Pope, RN, OCN, CCRC, 706-353-2990 ext. x8235, npope@universitycancer.com
Frederick Flynt, MD, FACP
Recruiting
University of Alabama
Birmingham, Alabama, 35294
Diana Avery, 205-957-7182, dinaavery@uabmc.edu
Lauren Shea, MD
Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Susan Gotthardt, RN, sgotthar@bidmc.harvard.edu
Hollis Viray, MD
Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Kailene Sullivan, RN, 617-632-3482, Kailene_sullivan@dfci.harvard.edu
Patrick Ott, MD, PhD
Recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
ASKRPCI, 800-767-9355, askroswell@roswellpark.org
Benjamin Switzer, DO
Recruiting
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46804
Andrea Vazquez, 260-436-0800 ext. 42165, andrea.vasquez@aoncology.com
Sunil Babu, MD
Recruiting
D&H Cancer Research Center
Margate, Florida, 33063
Withdrawn
Tennessee Oncology
Nashville, Tennessee, 37203
Lauren Carey, lcary@tnonc.com
Jeff Russell, MD
Recruiting
Florida Cancer Specialists - Lake Nona
Orlando, Florida, 32827
Elizabeth Gilmore, 904-380-2410, elizabeth.griffith@scri.com
Cesar Perez Batista, MD
Recruiting
Stanford Cancer Institute
Palo Alto, California, 94304
Anthony Yu, 650-498-5964, Anthyu20@stanford.edu
Ranjana Advani, MD
Recruiting
Florida Cancer Specialists - Sarasota
Sarasota, Florida, 34236
Judy Wang, MD
Recruiting
Summit Cancer Center
Spokane, Washington, 99208
Monika Chaudhry, 509-462-2273 opt 7, mchaudhry@summitcancercenters.com
Arvind Chaudhry, MD
Recruiting

Other trials in United States

About this study

Official title: A Phase 1, Open-Label, Multiple-Ascending Dose Study of the Safety and Tolerability of CTX-8371 in Patients With Advanced Malignancies

Read the detailed description

This Phase 1, open-label, first-in-human study will evaluate the safety, tolerability, immunogenicity, and pharmacokinetic profile of CTX-8371 monotherapy. Preliminary anti-tumor activity of CTX-8371 will also be assessed. The study will be conducted in 2 cohorts: Dose escalation and Dose expansion. The Dose Escalation Cohort will utilize a 3+3 design to evaluate five dose levels (0.1-10.0 mg/kg) of CTX-8371 given as an IV infusion once every 2 weeks. Patients in the Dose Expansion Cohort will receive CTX-8371 as an IV infusion at 3.0 mg/kg or 10.0 mg/kg at a 1:1 allocation.

Conditions: Non Small Cell Lung Cancer, Triple Negative Breast Cancer, Hodgkin Lymphoma, Head and Neck Squamous Cell Carcinoma, Malignant Melanoma
Being tested: CTX-8371
Medical subject headings: Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Neoplasms, Hodgkin Disease, Squamous Cell Carcinoma of Head and Neck, Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CTX-8371Drug
Intravenous (IV) infusion every two weeks.

Study groups in NCT06150664
Study group	Role	What they receive
Dose Escalation Cohort 1	Experimental	Escalating doses of CTX-8371 Receives: Drug: CTX-8371
Dose Expansion Cohort 2	Experimental	Two CTX-8371 dose groups (3.0 mg/kg and 10.0 mg/kg) in three tumor type subgroups (NSCLC, TNBC, and HL) Receives: Drug: CTX-8371

What is being measured

The primary outcome is the main question the study is designed to answer.

Cohort 1: Evaluate the safety and tolerability of escalating doses of CTX-8371
Number of participants with dose limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities
Measured: 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 1: Determine the dose(s) of CTX-8371 to be further examined in Cohort 2 and Phase 2 studies
Measured: 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
Incidence of treatment-emergent adverse events (TEAEs)
Measured: 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)

Secondary outcomes (16)

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
Measured: 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
Measured: 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
Measured: 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)
Cohort 1 and 2: Objective Response Rate (ORR) (Percentage of Participants With Objective Response) as per Lugano (2014)
Measured: Baseline until confirmed disease progression (up to 2 years)
Cohort 1 and 2: Duration of Response (DOR) as per Lugano (2014)
Measured: 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 Lugano (2014)
Measured: From first dose of CTX-8371(Cycle 1 Day 1,Cycle = 2 weeks ) until disease progression or death, whichever occurs first
Cohort 1 and 2: Overall Survival (OS) of CTX-8371
Measured: From first dose of CTX-8371 (Cycle 1 Day 1,Cycle = 2 weeks) until death (up to 2 years)
Cohort 1 and 2: Maximum serum concentration (Cmax) of CTX-8371
Measured: From first dose of CTX-8371 (Cycle 1 Day 1,Cycle = 2 weeks) until treatment discontinuation
Cohort 1 and 2: Time of maximum observed serum concentration (Tmax) of CTX-8371
Measured: From first dose of CTX-8371 (Cycle 1 Day 1, Cycle = 2 weeks) until treatment discontinuation
Cohort 1 and 2: Trough serum concentration (Ctrough) of CTX-8371
Measured: From first dose of CTX-8371 (Cycle 1 Day 1, Cycle = 2 weeks) until treatment discontinuation
Cohort 1 and 2: Area under the serum concentrations of CTX-8371 versus time curve (AUC) for CTX-8371
Measured: From first dose of CTX-8371 (Cycle 1 Day 1,Cycle = 2 weeks) until treatment discontinuation
Cohort 1 and 2: Clearance (CL) of serum concentrations of CTX-8371
Measured: From first dose of CTX-8371 (Cycle 1 Day 1, Cycle = 2 weeks) until treatment discontinuation
Cohort 1 and 2: Volume of distribution (Vd) of serum concentrations of CTX-8371
Measured: From first dose of CTX-8371 (Cycle 1 Day 1, Cycle = 2 weeks) until treatment discontinuation
Cohort 1 and 2: Half-life (t1/2) of serum concentrations of CTX-8371
Measured: From first dose of CTX-8371 (Cycle 1 Day 1, Cycle = 2 weeks) until treatment discontinuation
Cohort 1 and 2: Dose Response for CTX-8371
Measured: From first dose of CTX-8371 (Cycle 1 Day 1, Cycle = 2 weeks) until treatment discontinuation
Cohort 1 and 2: Assess the immunogenicity of CTX-8371
Screen for the presence and development of antibodies against CTX-8371
Measured: From first dose of CTX-8371 (Cycle 1 Day 1, Cycle = 2 weeks) until end of treatment visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Mar 2024May 2027

First posted29 Nov 2023
Study start19 Mar 2024
Primary completionDec 2026 (estimated)
Study completionMay 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 85 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06150664
Sponsor's protocol ID: CTX-8371-001
Status last verified: Apr 2026
First submitted: 17 Nov 2023
Last updated: 4 Nov 2026
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-Label, Multiple-Ascending Dose Study of the Safety and Tolerability of CTX-8371 in Patients With Advanced Malignancies
ClinicalTrials.gov ID: NCT06150664
Acronym / sponsor ID: CTX-8371-001
Conditions: Non Small Cell Lung Cancer, Triple Negative Breast Cancer, Hodgkin Lymphoma, Head and Neck Squamous Cell Carcinoma, Malignant Melanoma
Phase: Phase 1
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 85 participants (estimated)
Lead sponsor: Compass TherapeuticsIndustry (pharma, biotech, devices)
Study start: 19 Mar 2024 (actual)
Primary completion: Dec 2026 (estimated)
Study completion: May 2027 (estimated)
First posted: 29 Nov 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Dose Escalation Cohort 1	Experimental	Drug: CTX-8371Escalating doses of CTX-8371
Dose Expansion Cohort 2	Experimental	Drug: CTX-8371Two CTX-8371 dose groups (3.0 mg/kg and 10.0 mg/kg) in three tumor type subgroups (NSCLC, TNBC, and HL)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (44 listed)

Age 18 years or older
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
Patients with NSCLC, MM, TNBC, and HNSCC must have measurable disease per RECIST 1.1. Patients with HL must have at least one measurable lesion > 1.5 cm for nodal, > 1.0 cm for extranodal FDG-avid disease by the Lugano (2014) response criteria. Tumor sites that are considered measurable must not have received prior radiation
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Adequate bone marrow function defined by absolute neutrophil (ANC) of ≥ 1.5×109/L, platelet count of ≥ 100.0×109/L, and hemoglobin of ≥ 9.0 g/dL (with or without transfusion)

Key exclusion criteria (11 listed)

Developed clinically significant adverse reaction to PD-1 or PD-L1 therapy, including immune related adverse reactions, which led to discontinuation of treatment
Systemic therapy with immunosuppressive agents within 7 days before the start of CTX-8371 treatment. Topical, intranasal, intraocular, or inhaled corticosteroids and physiologic replacement for patients with adrenal insufficiency are allowed
Patient is a pregnant or lactating WOCBP
Prior organ transplantation
Patients with evidence of active hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection. Patients with positive HBsAg and/or detectable HBV DNA are eligible only if adequately controlled on antiviral therapy according to institutional standards and liver function eligibility criteria are also met. HCV patients showing sustained viral response or patients with immunity to HBV infection may enroll.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CTX-8371Intravenous (IV) infusion every two weeks.	Drug	Dose Escalation Cohort 1, Dose Expansion Cohort 2

Primary outcome

Cohort 1: Evaluate the safety and tolerability of escalating doses of CTX-8371
Time frame: 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
Time frame: 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
Time frame: 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)

16 secondary outcomes

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
Time frame: 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
Time frame: 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
Time frame: 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)
Cohort 1 and 2: Objective Response Rate (ORR) (Percentage of Participants With Objective Response) as per Lugano (2014)
Time frame: Baseline until confirmed disease progression (up to 2 years)
Cohort 1 and 2: Duration of Response (DOR) as per Lugano (2014)
Time frame: 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 Lugano (2014)
Time frame: From first dose of CTX-8371(Cycle 1 Day 1,Cycle = 2 weeks ) until disease progression or death, whichever occurs first
Cohort 1 and 2: Overall Survival (OS) of CTX-8371
Time frame: From first dose of CTX-8371 (Cycle 1 Day 1,Cycle = 2 weeks) until death (up to 2 years)
Cohort 1 and 2: Maximum serum concentration (Cmax) of CTX-8371
Time frame: From first dose of CTX-8371 (Cycle 1 Day 1,Cycle = 2 weeks) until treatment discontinuation
Cohort 1 and 2: Time of maximum observed serum concentration (Tmax) of CTX-8371
Time frame: From first dose of CTX-8371 (Cycle 1 Day 1, Cycle = 2 weeks) until treatment discontinuation
Cohort 1 and 2: Trough serum concentration (Ctrough) of CTX-8371
Time frame: From first dose of CTX-8371 (Cycle 1 Day 1, Cycle = 2 weeks) until treatment discontinuation
Cohort 1 and 2: Area under the serum concentrations of CTX-8371 versus time curve (AUC) for CTX-8371
Time frame: From first dose of CTX-8371 (Cycle 1 Day 1,Cycle = 2 weeks) until treatment discontinuation
Cohort 1 and 2: Clearance (CL) of serum concentrations of CTX-8371
Time frame: From first dose of CTX-8371 (Cycle 1 Day 1, Cycle = 2 weeks) until treatment discontinuation
Cohort 1 and 2: Volume of distribution (Vd) of serum concentrations of CTX-8371
Time frame: From first dose of CTX-8371 (Cycle 1 Day 1, Cycle = 2 weeks) until treatment discontinuation
Cohort 1 and 2: Half-life (t1/2) of serum concentrations of CTX-8371
Time frame: From first dose of CTX-8371 (Cycle 1 Day 1, Cycle = 2 weeks) until treatment discontinuation
Cohort 1 and 2: Dose Response for CTX-8371
Time frame: From first dose of CTX-8371 (Cycle 1 Day 1, Cycle = 2 weeks) until treatment discontinuation
Cohort 1 and 2: Assess the immunogenicity of CTX-8371
Time frame: From first dose of CTX-8371 (Cycle 1 Day 1, Cycle = 2 weeks) until end of treatment visit

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Natalie Warholic contact

617-500-8099

CTX-8371-001@compasstherapeutics.com

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CTX-8371 in people with Non Small Cell Lung Cancer and Triple Negative Breast Cancer, run by Compass Therapeutics at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 44 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Natalie Warholic (617-500-8099, CTX-8371-001@compasstherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cohort 1: Evaluate the safety and tolerability of escalating doses of CTX-8371 (time frame: 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06150664.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.