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New treatment option for Non Small Cell Lung Cancer
Official title A Phase 1 of CTX-8371 in Patients With Advanced Malignancies
ClinicalTrials.gov ID: NCT06150664
What this study is testing
What is CTX-8371?
CTX-8371 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age 18 years or older
- Patients must have a histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic disease that is...
- 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...
- Patients must have had prior testing for BRAF V600 mutations. Patients with BRAF V600 activating mutation must have received prior therapy with a...
You likely can't join if
- Developed clinically significant adverse reaction to PD-1 or PD-L1 therapy, including immune related adverse reactions, which led to discontinuation...
- Systemic therapy with immunosuppressive agents within 7 days before the start of CTX-8371 treatment. Topical, intranasal, intraocular, or inhaled...
- 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...
- Active autoimmune disease or medical conditions requiring chronic steroid (i.e., \> 10 mg/day prednisone or equivalent) or immunosuppressive therapy...
See the full eligibility criteria
Who can 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...
- 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
- 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...
- 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) a. (Cohort 2 Dose Expansion) Adequate bone...
- 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...
- 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...
- 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
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- QTc interval (using Fridericia correction calculation) \> 480 msec
The study team makes the final eligibility decision.
Where it's taking place
- Margate, Florida, United States
- Orlando, Florida, United States
- Sarasota, Florida, United States
- Athens, Georgia, United States
- Boston, Massachusetts, United States
- Buffalo, New York, United States
- Nashville, Tennessee, United States
- Spokane, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Margate, Florida, United States; Orlando, Florida, United States; Sarasota, Florida, United States; Athens, Georgia, United States; Boston, Massachusetts, United States; Buffalo, New York, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.