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 : August 6, 2020
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Condition or disease | Intervention/treatment | Phase |
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Locally Advanced Solid Tumor Metastatic Cancer | Drug: CTX-471 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 96 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | May 17, 2019 |
Estimated Primary Completion Date : | March 2021 |
Estimated Study Completion Date : | July 2021 |
Arm | Intervention/treatment |
---|---|
Experimental: Part 1 Dose Escalation
Escalating doses of CTX-471 depending on cohort at enrollment.
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Drug: CTX-471
IV infusion every 2 weeks |
Experimental: Part 2 Dose Expansion
Two dose groups of CTX-471 (0.3 mg/kg and 0.6 mg/kg)
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Drug: CTX-471
IV infusion every 2 weeks |
- 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) ]
- 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) ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 18 years or older
- Histologically confirmed diagnosis of metastatic or locally advanced malignancies
- Measurable disease per RECIST 1.1
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Life expectancy > 12 weeks
- 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)
- Adequate hepatic function defined as serum total bilirubin < 2 mg/dL, AST/ALT ≤ 2.5 × ULN (or ≤ 5 × ULN in patients with liver metastases)
- Adequate renal function defined as creatinine clearance >60 mL/min as determined by Cockcroft-Gault equation
- 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
- 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
- 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
- Resolution of all prior anti-cancer therapy toxicities ≤ Grade 1
- Willingness to provide pre- and post-treatment fresh tumor biopsies
- Capable of understanding and complying with protocol requirements
- Signed and dated institutional review board/independent ethics committee-approved informed consent form before any protocol-directed screening procedures are performed
Exclusion Criteria:
- Developed clinically significant adverse reaction to PD-1 or PD-L1 therapy, including immune related adverse reactions, which led to discontinuation of treatment
- Prior treatment with other investigational immune-oncology therapies
- 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
- Patient is a pregnant or lactating WCBP
- Prior organ transplantation
- 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
- 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
- History of central nervous system metastases
- History of seizure disorders
- 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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03881488
Contact: Jill Bossi | 617-500-8099 ext 118 | jill.bossi@compasstherapeutics.com |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Justin Gainor, MD | |
Dana-Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02215 | |
Contact: Mark Awad, MD, PhD | |
United States, Missouri | |
Washington University School of Medicine, Siteman Cancer Center | Recruiting |
Saint Louis, Missouri, United States, 63110 | |
Contact: Tanner Johanns, MD | |
United States, New Jersey | |
Hackensack University Medical Center | Recruiting |
Hackensack, New Jersey, United States, 07601 | |
Contact: Martin Gutierrez, MD | |
United States, New York | |
Mt Sinai | Recruiting |
New York, New York, United States, 10029 | |
Contact: Matthew Galsky, MD | |
United States, North Carolina | |
Duke University School of Medicine | Recruiting |
Durham, North Carolina, United States, 27705 | |
Contact: Jennifer Choe, MD, PhD | |
United States, South Carolina | |
Institute for Translational Oncology Research (ITOR) | Recruiting |
Greenville, South Carolina, United States, 29605 | |
Contact: W. Jeffrey Edenfield, MD | |
United States, Texas | |
Mary Crowley Cancer Research | Recruiting |
Dallas, Texas, United States, 75251 | |
Contact: Minal Barve, MD |
Study Director: | Thomas Scheutz, MD, PhD | Compass Therapeutics |
Responsible Party: | Compass Therapeutics |
ClinicalTrials.gov Identifier: | NCT03881488 |
Other Study ID Numbers: |
CTX-471-001 |
First Posted: | March 19, 2019 Key Record Dates |
Last Update Posted: | August 6, 2020 |
Last Verified: | August 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes |