A single arm phase II study with 30 patients of leronlimab (PRO 140) in patients with CCR5+ locally advanced or metastatic solid tumors.
Leronlimab (PRO 140) will be administered subcutaneously as weekly dose of 525 mg until disease progression or intolerable toxicity. Subjects participating in this study will be allowed to receive/continue standard-of-care chemotherapy or radiotherapy as per the dosing schedule included on the package insert. In this study, patients will be evaluated for tumor response approximately every 3 months or according to institution's standard practice by CT, PET/CT or MRI with contrast (per treating investigator's discretion) using the same method as at baseline.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Drug: Leronlimab 525mg
Quest Clinical Research
San Francisco, California, United States
Number of Participants With Adverse Events (AEs), and Serious Adverse Events (SAEs).
Adverse events were elicited through direct questioning and subject reports. Any abnormalities in visit evaluations, physical examination findings or laboratory results that the investigator believed were clinically significant to the research subject were reported as adverse events.
Time frame: From the time of first treatment (T1) until the last study visits completion (up to approximately 16 months)
Changes in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to Subsequent Scheduled Visits
The ECOG was utilized to assess the ability of patients to tolerate treatment. The ECOG is a 5-point scale, where a higher score indicates a greater lack of tolerance of the treatment. Response choices included: 0 = Asymptomatic; Fully active, able to carry on all pre-disease performance without restriction, 1 = Symptomatic but completely ambulatory; Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work, 2 = Symptomatic, \<50% in bed during the day; Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours, 3 = Symptomatic, \>50% in bed during the day; Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours, 4 = Bedbound; Completely disabled; cannot carry on any selfcare; totally confined to bed or chair, 5 = Dead.
Time frame: From the time of first treatment (T1) until the last study visits completion (up to approximately 16 months)
Progression Free Survival (PFS) Defined as Time in Months From the Date of First Study Treatment to the Date of Disease Progression or Death From Any Cause, Whichever Comes First.
The Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria was used for objective tumor response assessment (when disease is measurable and non- measurable); PFS is calculated from the date of first dose of leronlimab until date of clinical progressions.
Time frame: The time in months from start of treatment to progression or death will be measured for all patients who receive at least one dose of study drug. Participants were followed on study until last study visit completion up to approximately 16 months.
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Overall Response Rate (ORR, Defined as CR (Complete Response) + PR (Partial Response)) in Subjects With CCR5+ Locally Advanced or Metastatic Solid Tumors Treated With Leronlimab.
Overall response rate is defined as the percentage of patients who achieve an overall response of complete response or partial response in the total number of evaluable patients, assessed by RECIST v1.1.
Time frame: The time in months from start of treatment to progression or death will be measured for all patients who receive at least one dose of study drug. Participants were followed on study until last study visit completion up to approximately 16 months.
Mean Time to New Metastases (TTNM)
Recorded time from baseline metastatic disease (at time of enrollment) to the time of development of new metastasis in different site. New metastases in same site will be also recorded. TTNM will be calculated according to the formula: TTNM=(Date of new metastases - Date of first treatment) + 1.
Time frame: From the time of first treatment (T1) until the last study visits completion (up to approximately 16 months).
The Change From Baseline in Circulating Tumor Cells (CTC) Level in the Peripheral Blood.
Reported unit of measure will be the number of CTCs/milliliters. CTCs enumeration will be performed at baseline and at the time of response assessment. Fraction of baseline positive and change from ≥5 CTCs will be recorded and reported.
Time frame: From date of first treatment until the date of first documented progression or date of death from any cause, whichever came first. From the time of first treatment (T1) until the last study visits completion (up to approximately 16 months).
Overall Survival Defined as Time in Months From the Date of First Study Treatment to the Date of Death
Overall survival defined as time in months from the date of first study treatment to the date of death. Patients will be followed from the start of treatment (first dose) until long-term follow up date (up to 2 years post-treatment or death), whichever occurs first, and average survival time will be measured.
Time frame: Overall survival is calculated by long-term follow-up date - PRO 140 (leronlimab) start date, up to approximately 57 months.