Leronlimab (PRO 140) Combined With Carboplatin in Patients With CCR5+ mTNBC

  • STATUS
    Recruiting
  • days left to enroll
    32
  • participants needed
    48
  • sponsor
    CytoDyn, Inc.
Updated on 8 October 2021
cancer
serum pregnancy test
measurable disease
breast cancer
anthracyclines
metastasis
neutrophil count
carboplatin
triple negative breast cancer
erbb2
taxane
triple-negative breast cancer
mammogram
excisional biopsy

Summary

This is a phase Ib/II Study of Leronlimab (PRO 140) combined with Carboplatin in Patients with CCR5+ Metastatic Triple Negative Breast Cancer (mTNBC).

Study population will consist of patients with CCR5-positive, locally advanced or metastatic triple-negative breast cancer (mTNBC) who are nave to chemotherapy in metastatic setting but have been exposed to anthracyclines and taxane in neoadjuvant and adjuvant settings (first-line).

Description

Phase Ib

Phase Ib is a dose escalation phase with 3 dose levels (cohorts) of leronlimab (PRO 140) administered in combination with a fixed dose of carboplatin at AUC 5. This dose finding portion of study will follow a "3+3" designed to determine the maximum tolerated dose (MTD) of leronlimab (PRO 140) administered as subcutaneous injection in subjects with histologically confirmed mTNBC that express CCR5.

Phase II

Phase II is a single arm study with 30 patients in order to test the hypothesis that the combination of carboplatin AUC 5 intravenously and MTD of leronlimab (PRO 140) SC will increase PFS in patients with CCR5 + mTNBC.

Details
Condition Breast Cancer, Diet and Nutrition, Chronic Diarrhea, Skin Wounds, Chronic Shoulder Pain, Vaginal Atrophy, Adverse Effects, Drugs, Injection Port, Breast Cancer - HER2 Positive, Anal Dysplasia, Primary Immunodeficiency, Pediatric Health, Near-Sighted Corrective Surgery, Peripheral Arterial Occlusive Disease, Triple Negative Breast Cancer, Brain Function, Triple Negative Breast Neoplasms, Recurrent Respiratory Papillomatosis, Razor Bumps (Pseudofolliculitis Barbae), Metastatic Triple-Negative Breast Cancer
Treatment 350 mg leronlimab, 525 mg leronlimab, 700 mg leronlimab, AUC 5 Carboplatin, Maximum Tolerated Dose (MTD) of leronlimab
Clinical Study IdentifierNCT03838367
SponsorCytoDyn, Inc.
Last Modified on8 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Must have a histologically confirmed diagnosis of TNBC. Must demonstrate HER-2 negative (IHC 0, 1+, or fluorescence in situ hybridization (FISH) negative and ER<1%, and PR < 1%, per ASCO/CAP criteria)
Demonstrate CCR5 + by IHC (>10% membranous staining completed at the reference laboratory of Dr. Hallgeir Rui at Medical College of Wisconsin)
Note: This test will be done as part of the pre-screening period. It will be
performed in archival metastatic tissue. If archival tissue is not available
then, fresh biopsy will be done
\. Be willing to provide tissue from a newly obtained core or excisional
biopsy of a tumor lesion (in case archival tissue is not available)
\. Subjects must be untreated or nave to chemotherapy and/or checkpoint
inhibitors exposure in metastatic setting and have been exposed to
anthracyclines and taxane in neoadjuvant and adjuvant settings (first-line)
Note: Patients who have been exposed to carboplatin in neoadjuvant or adjuvant
setting will be allowed to enroll, if they have progressed 6 months from
completion of treatment
\. Patients must have measurable disease based on RECIST v1.1
\. Female patients, 18 years of age
\. Patients must exhibit a/an ECOG performance status of 0-1
\. Life expectancy of at least 6 months
\. Patients must have adequate organ and bone marrow function within 28 days
prior to registration, as defined below
leukocytes 3,000/mcL
absolute neutrophil count 1,500/mcL
platelets 100,000/mcL
total bilirubin: within normal institutional limits
AST(SGOT) &ALT(SPGT) 2.5 X institutional upper limit of normal (ULN) (applicable to all patients, irrespective of liver disease or metastasis); and
creatinine: within normal institutional limits. 10. Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator. 11. Females of child-bearing potential (FOCBP) and males must agree to use two medically accepted methods of contraception with hormonal or barrier method of birth control, or abstinence, prior to study entry, for the duration of study participation and for 60 days after the last dose of study drug (Refer to Appendix 1). Should a female patient become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. NOTE: A FOCBP is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria
Has not undergone a hysterectomy or bilateral oophorectomy; and
Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for > 12 months). 12. FOCBP must have a negative serum pregnancy test at Screening Visit and negative urine pregnancy test prior to receiving the first dose of study drug; and 13. Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study

Exclusion Criteria

HER-2 overexpressed/amplified MBC (Appendix 2 for guidelines from ASCO)
ER and or PR expressing tumors
Subjects who have had previous systemic chemotherapy for metastatic breast cancer
Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 28 days prior to enrollment
Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to leronlimab (PRO 140) are not eligible
Patients who have had prior exposure to CCR5 antagonists are not eligible
Patients who have a known additional malignancy that is progressing or requires active treatment are not eligible. Patients who have had a prior diagnosis of cancer and if it has been <3 years since their last treatment are not eligible. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer
Has an active infection requiring systemic therapy. Note: Patients must complete any treatment with antibiotics prior to registration
Patients who have a known HIV positive status or known/ active Hepatitis B and/or C infection are not eligible
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Note: Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial; and
Is pregnant or breastfeeding, or expecting to conceive or have children within the projected duration of the trial, starting with the pre-screening or screening visit through the duration of study participation
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