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Study of CTX-471 in Patients Post PD-1/PD-L1 Inhibitors in Metastatic or Locally Advanced Malignancies

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ClinicalTrials.gov Identifier: NCT03881488
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : July 30, 2021
Sponsor:
Collaborator:
Iqvia Pty Ltd
Information provided by (Responsible Party):
Compass Therapeutics

Tracking Information
First Submitted Date  ICMJE March 13, 2019
First Posted Date  ICMJE March 19, 2019
Last Update Posted Date July 30, 2021
Actual Study Start Date  ICMJE May 17, 2019
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2019)
  • Number of participants with dose limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities [ Time Frame: From first dose of CTX-471 (Week 1 Day 1) until 60 days after the last CTX-471 injection (up to 2 years) ]
  • Dose(s) of CTX 471 to be examined in Part 2 and the recommended Phase 2 dose(s) [ Time Frame: From first dose of CTX-471 (Week 1 Day 1) until 60 days after the last CTX-471 injection (up to 2 years) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2019)
  • Maximum serum concentration (Cmax) of CTX-471 [ Time Frame: From first dose of CTX-471 (Week 1 Day 1) until 60 days after the last CTX-471 injection (up to 2 years) ]
  • Area under the serum concentrations of CTX-471 versus time curve (AUC) [ Time Frame: From first dose of CTX-471 (Week 1 Day 1) until 60 days after the last CTX-471 injection (up to 2 years) ]
  • Half-life (t1/2) of serum concentrations of CTX-471 [ Time Frame: From first dose of CTX-471 (Week 1 Day 1) until 60 days after the last CTX-471 injection (up to 2 years) ]
  • Development of anti-drug antibodies (ADAs) and/or neutralizing antibodies of CTX-471 [ Time Frame: From first dose of CTX-471 (Week 1 Day 1) until 60 days after the last CTX-471 injection (up to 2 years) ]
  • 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 (CR or PR) (up to 2 years) ]
    ORR will be calculated as the number of participants with a confirmed complete response (CR) or a partial response (PR) divided by the number of participants dosed
  • 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) ]
  • Progression-Free Survival (PFS) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [ Time Frame: From first dose of CTX-471 (Week 1 Day 1) until disease progression or death, whichever occur first (up to 2 years) ]
  • Overall Survival (OS) [ Time Frame: From first dose of CTX-471 (Week 1 Day 1) until death (up to 2 years) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of CTX-471 in Patients Post PD-1/PD-L1 Inhibitors in Metastatic or Locally Advanced Malignancies
Official Title  ICMJE A Phase 1, Open-Label, Multiple-Ascending Dose Study of the Safety and Tolerability of CTX-471 in Patients With Inadequate Responses to PD-1/PD-L1 Checkpoint Inhibitors in Metastatic or Locally Advanced Malignancies
Brief Summary This is a Phase 1, open-label, first-in-human study of CTX-471 monotherapy in patients with metastatic or locally advanced malignancies that have progressed while receiving an approved PD-1 or PD-L1 inhibitor. The study will be conducted in 2 parts: Part 1 Dose Escalation and Part 2 Dose Expansion.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Locally Advanced Solid Tumor
  • Metastatic Cancer
Intervention  ICMJE Drug: CTX-471
IV infusion every 2 weeks
Study Arms  ICMJE
  • Experimental: Part 1 Dose Escalation
    Escalating doses of CTX-471 depending on cohort at enrollment.
    Intervention: Drug: CTX-471
  • Experimental: Part 2 Dose Expansion
    Two dose groups of CTX-471 (0.3 mg/kg and 0.6 mg/kg)
    Intervention: Drug: CTX-471
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 5, 2020)
96
Original Estimated Enrollment  ICMJE
 (submitted: March 18, 2019)
81
Estimated Study Completion Date  ICMJE September 2022
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age 18 years or older
  2. Histologically confirmed diagnosis of metastatic or locally advanced malignancies
  3. Measurable disease per RECIST 1.1
  4. Disease progression after at least 12 weeks and at least 2 doses of a commercially available PD-1 or PD-L1 inhibitor per approved prescriber's information, whether monotherapy or in combination therapy, with no other intervening systemic anticancer therapy prior to enrollment
  5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  6. Life expectancy > 12 weeks
  7. Adequate bone marrow function defined by ANC of ≥ 1.5×10^9/L, platelet count of ≥100.0×10^9/L, and hemoglobin of ≥ 9.0 g/dL (with or without transfusion)
  8. Adequate hepatic function defined as serum total bilirubin < 2 mg/dL, AST/ALT ≤ 2.5 × ULN (or ≤ 5 × ULN in patients with liver metastases)
  9. Adequate renal function defined as creatinine clearance >60 mL/min as determined by Cockcroft-Gault equation
  10. Female patients must be surgically sterile (or have a monogamous partner who is surgically sterile) or be least 2 years postmenopausal or commits to use 2 acceptable forms of birth control (defined as the use of an intrauterine device, 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
  11. Female patients who are women of childbearing potential (WCBP) must have a negative serum pregnancy test at Screening within 7 days of dosing with CTX-471
  12. 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-471 treatment), or surgical intervention >21 days prior to the first dose of CTX-471
  13. Resolution of all prior anti-cancer therapy toxicities ≤ Grade 1
  14. Willingness to provide pre- and post-treatment fresh tumor biopsies
  15. Capable of understanding and complying with protocol requirements
  16. Signed and dated institutional review board/independent ethics committee-approved informed consent form 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. Prior treatment with other investigational immune-oncology therapies
  3. Systemic therapy with immunosuppressive agents within 7 days before the start of CTX-471 treatment. Topical, intranasal, intraocular, or inhaled corticosteroids and physiologic replacement for patients with adrenal insufficiency are allowed
  4. Patient is a pregnant or lactating WCBP
  5. Prior organ transplantation
  6. Active hepatitis B virus, hepatitis C virus, or human immunodeficiency virus infection or a positive serological test at Screening within 28 days of dosing with CTX 471
  7. Active autoimmune disease or medical conditions requiring chronic steroid (ie, > 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
  8. History of central nervous system metastases
  9. History of seizure disorders
  10. 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
  11. Other systemic conditions or organ abnormalities that in the opinion of the Investigator may interfere with the conduct and/or interpretation of the current study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jill Bossi 617-500-8099 ext 118 jill.bossi@compasstherapeutics.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03881488
Other Study ID Numbers  ICMJE CTX-471-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Compass Therapeutics
Study Sponsor  ICMJE Compass Therapeutics
Collaborators  ICMJE Iqvia Pty Ltd
Investigators  ICMJE
Study Director: Thomas Scheutz, MD, PhD Compass Therapeutics
PRS Account Compass Therapeutics
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP