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Clinical Trial 20474

Cancer Type: Thoracic
Study Type: Treatment
NCT#: NCT03319628

Phase: Phase I
Prinicipal Investigator: Andreas Saltos

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Overview

Study Title

A Phase 1b, First-in-Human, Dose Escalation and Expansion Study of XMT-1536 In Patients with Solid Tumors Likely to Express NaPi2b

Summary

This is a multi-center study of XMT-1536 in patients with tumors likely to express NaPi2b.

Objective

Primary in Dose Escalation (DES): Determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of XMT-1536 administered intravenously once every four weeks Assess the safety and tolerability of XMT-1536 Primary in Expansion (EXP): Assess further the safety and tolerability of XMT-1536 administered at the MTD/RP2D identified in the DES Assess the preliminary anti-neoplastic activity of XMT-1536 Secondary in DES: Assess the preliminary anti-neoplastic activity of XMT-1536 Secondary in DES and EXP: Assess the pharmacokinetics (PK) of XMT-1536, its release product, and selected metabolites Assess the development of anti-drug antibodies to XMT-1536 Assess the association of tumor expression of NaPi2b and objective tumor response to XMT-1536 Assess safety and efficacy in ovarian cancer subpopulations, including patients previously treated and failed therapy with bevacizumab and patients with and without BRCA mutation who were previously treated and failed therapy with PARP inhibitors Exploratory in DES and EXP: Retrospectively evaluate the association of objective response with tumor expression of genes other than NaPi2b, or other tumor molecular and histologic features

Treatments

Therapies

Medications

XMT-1536 ()

Inclusion Criteria

  • 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. In EXP, ability to undergo a fresh biopsy before enrollment, unless not medically feasible.
  • 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.

  • 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: (a) Are untreated. (b) Are progressive (c) 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. (d) 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.
  • Prior use of mirvetuximab soravtansine or another ADC containing an auristatin or maytansinoid payload.

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