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

NCT06150664 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CTX-8371-001
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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)

  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

  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)

• Cohort 1 and 2: Objective Response Rate (ORR) (Percentage of Participants With Objective Response) as per Lugano (2014)

  Baseline until confirmed disease progression (up to 2 years)

• Cohort 1 and 2: Duration of Response (DOR) as per Lugano (2014)

  From the date of first confirmed CR or PR until the first date of recurrent or progressive disease (up to 2 years)

Study Arms (2)

Dose Escalation Cohort 1

EXPERIMENTAL

Escalating doses of CTX-8371

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)

Drug: CTX-8371

Interventions

CTX-8371 DRUG

Intravenous (IV) infusion every two weeks.

Dose Escalation Cohort 1; Dose Expansion Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Compass Therapeutics: lead

Study Sites (9)

D&H Cancer Research Center

Margate, Florida, 33063, United States

WITHDRAWN

Florida Cancer Specialists - Lake Nona

Orlando, Florida, 32827, United States

RECRUITING

Florida Cancer Specialists - Sarasota

Sarasota, Florida, 34236, United States

RECRUITING

University Cancer & Blood Center

Athens, Georgia, 30607, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

RECRUITING

Tennessee Oncology

Nashville, Tennessee, 37203, United States

RECRUITING

Summit Cancer Center

Spokane, Washington, 99208, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Triple Negative Breast Neoplasms; Hodgkin Disease; Squamous Cell Carcinoma of Head and Neck; Melanoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphoma; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms

Central Study Contacts

Natalie Warholic

CONTACT

617-500-8099; CTX-8371-001@compasstherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: November 29, 2023
• Study Start: March 19, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

US (9)