Moffitt Cancer Center: Clinical Trial 18855

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Clinical Trial 18855

Cancer Type: Multiple
Interventions:KHK2455; KW-0761 (Mogamulizumab); Mogamulizumab

Study Type: Treatment
Phase of Study: Phase I
Investigators:

Solmaz Sahebjam

Call 813-745-6100
or 1-800-679-0775

Overview

Study Title

Multicenter, Open-label, Phase 1, Dose-escalation,Cohort-expansion, First-in-Human Study of KHK2455 Administered as Monotherapy and in Combination with Mogamulizumab (KW-0761) in Adult Subjects with Locally Advanced or Metastatic Solid Tumors

Summary

The purpose of this study is to: - Test side effects (safety) of KHK2455 taken in combination with mogamulizumab. - Identify the highest tolerable dose of KHK2455 taken in combination with mogamulizumab that can be given safely. - See if it helps people with locally advanced or metastatic solid tumors.

Objective

Primary: -To characterize the safety, tolerability, and determine the maximum tolerated dose (MTD) or the highest protocol-defined dose, in the absence of exceeding the MTD, of KHK2455 administered orally in combination with mogamulizumab to subjects with locally advanced or metastatic solid tumors. Secondary: -To characterize the pharmacokinetic (PK) profile of KHK2455 when administered alone and in combination with mogamulizumab; -To assess the effect of KHK2455 on indoleamine 2,3-dioxygenase (IDO)inhibition (kynurenine/tryptophan ratio) when KHK2455 is administered alone and in combination with mogamulizumab; -To describe any anti-tumor responses when KHK2455 is administered alone and in combination with mogamulizumab. Exploratory: -To assess the effect of KHK2455 on other pharmacodynamic (PD) markers when KHK2455 is administered alone and in combination with mogamulizumab; -To explore PK/PD relationships for anti-tumor response, PD markers, and safety; -To evaluate the effect of KHK2455 on the immunogenicity and serum concentrations of mogamulizumab.

Inclusion Criteria

Participants must have histological or cytological evidence of a solid malignancy.

Have measurable neoplastic disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Have locally advanced or metastatic solid tumor with no additional therapy options available that are known to provide clinical benefit per institutional standards

Able to understand and willing to sign the Informed Consent Form (ICF), according to institutional standards, prior to the initiation of any study related procedures

Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Have a life expectancy of > 3 months, in the Investigator's judgment

Left ventricular ejection fraction of ≥ 50%

Adequate organ function within 28 days prior to Cycle 0 Day 1 (monotherapy run-in period)

Have recovered (i.e., to Grade ≤ 1 or to a baseline level) from the effects of surgery, radiotherapy, chemotherapy, hormonal therapy, or other therapies for cancer; with the exception of vitiligo, alopecia, neuropathy, partial hearing loss, and/or endocrinopathies (for which no resolution is required)

If on prior chemotherapeutic, immunomodulator (such as anti-CTLA-4, anti-PD-1 or anti-PD-L1 inhibitor), investigational, or other therapies for the treatment of cancer must wait at least 28 days after the last dose of these therapies before administration of the first dose of the IMP.

Males and women of child-bearing potential (WOCBP) must agree to use a medically-effective, double-barrier method of contraception (as defined in the ICF) to prevent pregnancy while on study and for 90 days after the last dose of IMP. WOCBP must also follow pregnancy test procedures.

Must have a brain scan performed during Screening or within 3 months prior to signing informed consent

Must be able to swallow solid dosage forms

Exclusion Criteria

Is enrolled (concurrently) in another investigational study, with the exception of the follow-up period of another investigational study in which no anti-cancer therapy is being administered and where only data are being collected

Has been previously treated with an anti-CCR4 antibody or an IDO1 inhibitor

A history of severe hypersensitivity reactions to any of the other excipients of the protocol investigational medicinal products (IMPs)

Women who are pregnant or breast-feeding, or intend to become pregnant during their participation in the study (including up to 90 days after the last dose of IMP); or males who intend to father a child during their participation in the study (including up to 90 days after the last dose of IMP)

Has known primary immunodeficiency or active tuberculosis or tests positive for acquired human immunodeficiency virus

Test positive for hepatitis B surface antigen (HBVsAg) or hepatitis C ribonucleic acid (RNA) indicating acute or chronic infection

Have undergone a major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of KHK2455 or is still recovering from prior surgery

A mean QT interval corrected for heart rate using Bazett's (QTcB) or Fridericia's (QTcF) correction ≥ 500 ms calculated from 3 consecutive 12-lead ECGs at Screening

An uncontrolled concurrent illness

Have Gilbert's syndrome

A known active central nervous system (CNS) metastasis, except primary brain tumors. Potential participants with asymptomatic brain metastases or spinal cord compression who have been treated, are considered stable, and have not received steroid doses > 10 mg/day of prednisolone equivalent to treat these conditions prior to consent may be included.

Any prior Grade ≥ 3 irAE to other therapeutic proteins or immunotherapy, and the reaction could not be controlled or prevented on subsequent infusion with standard therapies such as antihistamines, 5-hydroxytryptamine antagonists, or corticosteroids

History of organ transplant or allogeneic bone marrow transplant

Currently using or have received immunosuppressive medications within 14 days prior to the first dose of KHK2455, with the exception of topical or systemic corticosteroids that are not to exceed 10 mg/day of prednisone or equivalent

History of autoimmune disease. Exceptions: vitiligo, endocrinopathies, alopecia, psoriasis not requiring systemic treatment within the past 6 months.

History of second primary cancer within the past 5 year. Exceptions: Curatively resected non-melanoma skin cancer; Curatively treated cervical intraepithelial neoplasia or prostate carcinoma with current prostate specific antigen less than 0.01 ng/mL; or Curatively treated ductal carcinoma in situ of the breast.

A condition(s) that, in the opinion of the Investigator and/or Sponsor, would interfere with evaluation of the IMP or interpretation of the participant's safety or study results.