Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06150664
Other study ID # CTX-8371-001
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date March 19, 2024
Est. completion date April 2026

Study information

Verified date October 2023
Source Compass Therapeutics
Contact Natalie Warholic
Phone 617-500-8099
Email CTX-8371-001@compasstherapeutics.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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 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 a dose(s) based on data from the Dose Escalation Cohort.


Recruitment information / eligibility

Status Recruiting
Enrollment 55
Est. completion date April 2026
Est. primary completion date October 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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. 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 Exclusion Criteria: 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
CTX-8371
Intravenous (IV) infusion (0.1-10.0 mg/kg) every two weeks.

Locations

Country Name City State
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Florida Cancer Specialists - Lake Nona Orlando Florida
United States Florida Cancer Specialists - Sarasota Sarasota Florida

Sponsors (1)

Lead Sponsor Collaborator
Compass Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Cohort 1: Determine the dose(s) of CTX-8371 to be further examined in 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 )
Primary Cohort 2: Evaluate the safety and tolerability of CTX-8371 at dose(s) selected from Cohort 1 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 Objective Response Rate (ORR) (Percentage of Participants With Objective Response) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 or Lugano (2014) Baseline until confirmed disease progression (CR or PR) (up to 2 years)
Secondary Duration of Response (DOR) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 or Lugano (2014) From the date of first confirmed CR or PR until the first date of recurrent or progressive disease (up to 2 years
Secondary Progression-Free Survival (PFS) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 or Lugano (2014) 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)
Secondary Overall Survival (OS) of CTX-8371 From first dose of CTX-8371 (Cycle 1 Day 1,Cycle = 2 weeks) until death (up to 2 years)
Secondary Maximum serum concentration (Cmax) of CTX-8371 From first dose of CTX-8371 (Cycle 1 Day 1,Cycle = 2 weeks) until treatment discontinuation
Secondary Time of maximum observed serum concentration (Tmax) of CTX-8371 From first dose of CTX-8371 (Cycle 1 Day 1, Cycle = 2 weeks) until treatment discontinuation
Secondary Trough serum concentration (Ctrough) of CTX-8371 From first dose of CTX-8371 (Cycle 1 Day 1, Cycle = 2 weeks) until treatment discontinuation
Secondary Area under the serum concentrations of CTX-8371 versus time curve (AUC) for CTX-8371 From first dose of CTX-8371 (Cycle 1 Day 1,Cycle = 2 weeks) until treatment discontinuation
Secondary Clearance (CL) of serum concentrations of CTX-8371 From first dose of CTX-8371 (Cycle 1 Day 1, Cycle = 2 weeks) until treatment discontinuation
Secondary Volume of distribution (Vd) of serum concentrations of CTX-8371 From first dose of CTX-8371 (Cycle 1 Day 1, Cycle = 2 weeks) until treatment discontinuation
Secondary Half-life (t1/2) of serum concentrations of CTX-8371 From first dose of CTX-8371 (Cycle 1 Day 1, Cycle = 2 weeks) until treatment discontinuation
Secondary Dose Response for CTX-8371 From first dose of CTX-8371 (Cycle 1 Day 1, Cycle = 2 weeks) until treatment discontinuation
Secondary Assess the immunogenicity of CTX-8371 Screen for the presence and development of antibodies against CTX-8371 From first dose of CTX-8371 (Cycle 1 Day 1, Cycle = 2 weeks) until end of treatment visit
See also
  Status Clinical Trial Phase
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Recruiting NCT05707286 - Pilot Study to Determine Pro-Inflammatory Cytokine Kinetics During Immune Checkpoint Inhibitor Therapy
Recruiting NCT04258137 - Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study N/A
Completed NCT01945021 - Phase II Safety and Efficacy Study of Crizotinib in East Asian Patients With ROS1 Positive, ALK Negative Advanced NSCLC Phase 2
Completed NCT04487457 - Prospective Study to Evaluate the Blood Kinetics of Immune Cells and Immunosuppressive Cytokines After Exposure to an Immunity Checkpoint Inhibitor (ICI): Study of the Impact of Chemotherapy
Terminated NCT04022876 - A Study of ALRN-6924 for the Prevention of Chemotherapy-induced Side Effects (Chemoprotection) Phase 1
Recruiting NCT05898763 - TEIPP Immunotherapy in Patients With NSCLC Phase 1/Phase 2
Recruiting NCT05532696 - Phase 1b/2 Study to Evaluate ABT-101 in Solid Tumor and NSCLC Patients Phase 1/Phase 2
Completed NCT04311034 - A Study of RC48-ADC in Subjects With Advanced Non-small Cell Lung Cancer Phase 1/Phase 2
Active, not recruiting NCT03177291 - Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC Phase 1
Terminated NCT03257722 - Pembrolizumab + Idelalisib for Lung Cancer Study Phase 1/Phase 2
Completed NCT00349089 - Trial on Refinement of Early Stage Lung Cancer Adjuvant Therapy Phase 2
Completed NCT05116891 - A Phase 1/2 Study of CAN04 in Combination With Different Chemotherapy Regimens in Subjects With Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT04571632 - Clinical Trial of SBRT and Systemic Pembrolizumab With or Without Avelumab/Ipilimumab+ Dendritic Cells in Solid Tumors Phase 2
Terminated NCT03599518 - DS-1205c With Gefitinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer Phase 1
Not yet recruiting NCT06020989 - Lazertinib and Chemotherapy Combination in EGFR-mutant NSCLC Patients Without ctDNA Clearance After lead-in Lazertinib Monotherapy Phase 2
Withdrawn NCT03982134 - PDR001 + Panobinostat for Melanoma and NSCLC Phase 1
Withdrawn NCT03574649 - QUILT-2.024: Phase 2 Neoadjuvant, Consolidation, and Adjuvant Combination NANT Immunotherapy Versus Standard of Care in Subjects With Resectable Non-small Cell Lung Cancer Phase 2
Withdrawn NCT02844140 - DE-CT in Lung Cancer Proton Therapy N/A
Terminated NCT02628535 - Safety Study of MGD009 in B7-H3-expressing Tumors Phase 1