RECRUITING

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

Conditions

Non Small Cell Lung Cancer Triple Negative Breast Cancer Hodgkin Lymphoma Head and Neck Squamous Cell Carcinoma Malignant Melanoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-03-19

Study Completion:2026-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06150664

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. 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. 2. 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. 3. 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. 4. 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 (IHC 1+ or FISH-negative) are excluded. * Patients must have received prior sacituzumab govitecan and if PD-L1 ≥10% by CPS pembrolizumab with chemotherapy. 5. 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 3. 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 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 5. 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) 6. Adequate hepatic function defined as serum total bilirubin ≤ 1.5 × ULN, AST/ALT ≤ 2.5 × ULN (or ≤ 5 × ULN in patients with liver metastases) 7. Adequate renal function defined as creatinine clearance ≥ 30mL/min by Cockcroft-Gault equation 8. 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. 9. 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 10. 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 11. Resolution of all prior anti-cancer therapy toxicities ≤ Grade 2 12. Capable of understanding and complying with protocol requirements 13. Signed and dated institutional review board (IRB)/independent ethics committee (IEC)-approved informed consent form (ICF) before any protocol-directed screening procedures are performed	1. Developed clinically significant adverse reaction to PD-1 or PD-L1 therapy, including immune related adverse reactions, which led to discontinuation of treatment 2. 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 3. Patient is a pregnant or lactating WOCBP 4. Prior organ transplantation 5. 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. 6. 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 7. 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: 1. 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 2. QTc interval (using Fridericia correction calculation) \> 480 msec

Inclusion Criteria

Exclusion 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. 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.
2. 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.
3. 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.
4. 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 (IHC 1+ or FISH-negative) are excluded.
* Patients must have received prior sacituzumab govitecan and if PD-L1 ≥10% by CPS pembrolizumab with chemotherapy.
5. 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
3. 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
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
5. 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)
6. Adequate hepatic function defined as serum total bilirubin ≤ 1.5 × ULN, AST/ALT ≤ 2.5 × ULN (or ≤ 5 × ULN in patients with liver metastases)
7. Adequate renal function defined as creatinine clearance ≥ 30mL/min by Cockcroft-Gault equation
8. 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.
9. 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
10. 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
11. Resolution of all prior anti-cancer therapy toxicities ≤ Grade 2
12. Capable of understanding and complying with protocol requirements
13. Signed and dated institutional review board (IRB)/independent ethics committee (IEC)-approved informed consent form (ICF) before any protocol-directed screening procedures are performed

1. Developed clinically significant adverse reaction to PD-1 or PD-L1 therapy, including immune related adverse reactions, which led to discontinuation of treatment
2. 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
3. Patient is a pregnant or lactating WOCBP
4. Prior organ transplantation
5. 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.
6. 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
7. 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:
1. 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
2. QTc interval (using Fridericia correction calculation) \> 480 msec

Contacts and Locations

Study Contact

Natalie Warholic

CONTACT

617-500-8099

CTX-8371-001@compasstherapeutics.com

Study Locations (Sites)

D&H Cancer Research Center

Margate, Florida, 33063

United States

Florida Cancer Specialists - Lake Nona

Orlando, Florida, 32827

United States

Florida Cancer Specialists - Sarasota

Sarasota, Florida, 34236

United States

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

United States

Roswell Park Cancer Institute

Buffalo, New York, 14263

United States

Collaborators and Investigators

Sponsor: Compass Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-19

Study Completion Date2026-04

Study Record Updates

Study Start Date2024-03-19

Study Completion Date2026-04

Terms related to this study

Additional Relevant MeSH Terms

Non Small Cell Lung Cancer
Triple Negative Breast Cancer
Hodgkin Lymphoma
Head and Neck Squamous Cell Carcinoma
Malignant Melanoma