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Official Title

A Phase 1, First-in-human, Dose Escalation and Expansion, Multicenter Study of XMT-1660 in Participants With Solid Tumors

Phase
Phase 1
Sponsor
Mersana Therapeutics
Enrollment
319
Timeline
Aug 2022 → May 2027
About This Study

A Study of XMT-1660 in Solid Tumors

Eligibility Criteria

Inclusion Criteria

  • 1Recurrent or advanced solid tumor and has disease
  • 2Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • 3Participants in DES must have at least one non-target lesion as defined by RECIST version 1.1. Participants in Backfill Cohorts and EXP must have at least one measurable disease (target) lesion as defined by RECIST version 1.1.
  • 4Tumor tissue, either archival or from a fresh tumor biopsy, available for testing or be willing to undergo a minimally invasive tumor biopsy to obtain tumor tissue for local testing, if not medically contraindicated, prior to Cycle 1 Day 1
  • 5Brain magnetic resonance imaging (MRI) during the Screening period unless obtained within 30 days prior to Screening (based on standard clinical care), if they meet either of the following criteria:
  • 6All participants with TNBC
  • 7Participants with a history of brain metastases or with neurologic symptoms or signs suspicious for brain metastases.

Exclusion Criteria

  • 1Prior treatment with an Antibody Drug Conjugate (ADC) containing an auristatin payload. Prior treatment with another ADC containing other payloads is allowed.
  • 2Major surgery within 28 days of starting study treatment, systemic anticancer therapy within the time period of 28 days or 5 half-lives of the prior therapy before starting study treatment (14 days or 5 half-lives for small molecule targeted therapy), whichever is less, or palliative radiation therapy to the chest within 3 months of starting study treatment or to other anatomic sites within 14 days of starting study treatment.
  • 3Diagnosis of additional malignancy that required active treatment (including surgery, systemic therapy, and radiation) within 2 years prior to screening, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix.
  • 4Untreated CNS metastases (including new and progressive brain metastases), history of leptomeningeal metastasis or carcinomatous meningitis.
  • 5Prior B7-H4 targeted treatment.
  • 6History of cirrhosis, hepatic fibrosis, esophageal or gastric varices, or other clinically significant liver diseases.
  • 7Current severe, uncontrolled systemic disease (e.g. clinically significant cardiovascular, pulmonary, or metabolic disease) or intercurrent illness that could increase the risk of serious adverse events (SAEs) or interfere with per-protocol evaluations, in the judgment of either the Sponsor or the Investigator.
  • 8Clinically significant cardiovascular disease

Locations

26 sites participating in this study

Winship Cancer Institute, Emory University

Atlanta, Georgia 30322

Recruiting

Kevin Kalinsky, MD

Mayo Clinic Comprehensive Cancer Center

Phoenix, Arizona 85054

Recruiting

Felipe Batalini, MD

UC Irvine Health-Chao Family Comprehensive Cancer Center

Orange, California 92868

Recruiting

Ritesh Parajuli

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →