MC# 19-05 - A Phase Ib, First-in-Human, Dose Escalation and Expansion Study of XMT-1536 In Patients with Solid Tumors Likely to Express NaPi2b

  • Agent(s): XMT-1536
  • Disease Type(s): Lung-NSCLC, Thyroid, Salivary Duct, Renal, Endometrial, Ovarian
  • Phase(s): I
  • Drug Classification(s): Targeted Therapy, Immunotherapy, Monoclonal Antibody
  • Molecular Target(s): NaPi2b

Mechanism of Action

XMT-1536 is an anti-NaPi2b ADC conjugated to XMT-1535, a novel humanized anti-NaPi2b antibody, via the Dolaflexin ADC platform.

Purpose

In this study, the sponsor and investigators want to learn:

  • About the safety and tolerability of XMT-1536
  • How much of XMT-1536 is absorbed into the blood and how fast it is removed
  • How proteins that indicate the status of your disease are affected with use of XMT-1536
  • If your body develops proteins that work against XMT-1536
  • If XMT-1536 prevents or delays tumor growth or shrinks an existing tumor
  • If the amount of NaPi2b (a protein on the surface of the cells of your tumor) on tumor cells can indicate how well XMT-1536 works at the cellular level
Inclusion Criteria
  • Must be 18 years or older
  • Ability to give informed consent
  • ECOG performance status 0 or 1
  • Measurable disease as per RECIST, version 1.1
  • Resolution of all acute toxic effects of prior therapy or surgical procedures to Grade ≤1 (except alopecia)
  • Adequate organ function
  • Confirmed availability of tumor tissue blocks or freshly cut tissue slides for NaPi2b testing
  • For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly effective form of hormonal contraception or two effective forms of non-hormonal contraception by the patient and/or partner, and to continue the use of contraception for the duration of study treatment and for at least 6 months after the last dose of study treatment
  • Histologically or cytologically confirmed solid tumors of the types specified below, with incurable, locally advanced or metastatic disease that has failed standard therapy or for which no standard treatment option exists

For Ovarian Cancer

  • Histological diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer
  • Platinum resistance, serous, defined as disease progression within 6 months of completing a platinum-containing chemotherapy regimen

For NSCLC

  • Histological diagnosis of non-squamous NSCLC
  • Prior treatment with a platinum-based (cisplatin or carboplatin) regimen and a PD-1 or PD-L1 monoclonal antibody (either in combination or sequentially)
  • Patients with known oncogenic mutations for which there are approved therapies must have documented intolerance or disease progression for the approved therapies for their mutation
Exclusion Criteria
  • Major surgery within 28 days of starting study treatment; -or- systemic anti-cancer therapy within the lesser of 28 days or 5 half-lives of the prior therapy before starting study treatment -or- recent radiation therapy with unresolved toxicity
  • Brain metastases that:
    • Are untreated
    • Are progressive
    • Or have required any type of major treatment, e.g., whole brain radiation treatment, adjuvant chemotherapy, gamma knife, to control symptoms from brain metastases within 30 days of the first study treatment
    • Or any history of leptomeningeal metastasis
  • Current known active infection with HIV, hepatitis B virus, or hepatitis C virus
  • No prior history of liver disease such as liver cirrhosis, hepatic fibrosis
  • Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease) or intercurrent illness that could interfere with per-protocol evaluations
  • Severe dyspnea at rest due to complications of advanced malignancy, or requiring supplementary oxygen therapy
  • Currently active pneumonitis or interstitial lung disease
  • Pregnant or nursing women
  • History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or other malignancy with a similar expected curative outcome
  • Participation in the DES component of the study

Location

  • Dallas, TX - Mary Crowley Cancer Research - Medical City
More Info: https://clinicaltrials.gov/ct2/show/NCT03319628

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Re: MC# 19-05