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Closed (no longer recruiting)Last updated: 2 February 2024

MERSANA: This phase I/II trial is evaluating the safety and clinical activity of a new intravenous cancer treatment for people with high grade serous ovarian cancer or non-small cell lung cancerA Phase 1b, First-in-Human, Dose Escalation and Expansion Study of XMT-1592 In Patients With Solid Tumors Likely to Express NaPi2b

Clinical summary

Summary

This is a dose escalation and expansion trial, consisting of two parallel cohorts of patients (high grade serous ovarian cancer and non-small cell lung cancer). In the dose escalation part of the trial, increasing doses of XMT-1592 will be administered to groups of patients over time, until the maximum tolerated dose is achieved. In the dose expansion (confirmation) part of the trial, new groups of patients will receive XMT-1592 at the maximum tolerated dose to confirm the recommended Phase 2 dose. XMT-1592 will be administered once every 21 days.

Conditions

This trial is treating patients with high grade serous ovarian cancer or non-small cell lung cancer.

Cancer

Multi-Cancer Multi-Cancer

Age

People18 - 95

Phase

I/II

Trial Acronym

MERSANA

More information

Trial Identifiers

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Trial sponsor

Mersana Therapeutics, in collaboration with IQVIA Biotech

Scientific Title

A Phase 1b, First-in-Human, Dose Escalation and Expansion Study of XMT-1592 In Patients With Solid Tumors Likely to Express NaPi2b

Eligibility

Inclusion

  • 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.
  • Ovarian Cancer: Histological diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer, excluding the mucinous subtype.

NSCLC: Histological diagnosis of nonsquamous NSCLC.

Exclusion

  • 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, progressive, 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.
  • Prior use of mirvetuximab soravtansine or another ADC containing an auristatin or maytansinoid payload.

Inclusion

  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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