Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorEMD Serono Research & Development Institute, Inc.

About this trial

The purpose of this first-in-human (FIH) study is to evaluate the safety, tolerability, Pharmacokinetics (PK), and preliminary clinical activity of M7437 in participants with locally advanced or metastatic solid tumors with known Ly6E expression, including non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), epithelial ovarian carcinoma (EOC), squamous cell carcinoma of the head and neck (SCCHN), pancreatic ductal adenocarcinoma (PDAC), and gastric cancer (GC).

Eligibility criteria

Qualifiers

Participants have histologically proven advanced solid tumors with known prevalent and high Ly6E expression, Disease characteristic: Participants should have an unresectable locally advanced or metastatic solid tumor that is refractory to standard therapies, or have no standard therapies, or for which no standard therapy is judged appropriate by the Investigator.

Non-small cell lung cancer (nonsquamous or squamous)

Triple-negative breast cancer

Squamous cell carcinoma of head and neck

Disqualifiers

Participant has a history of another malignancy within 3 years before the date of enrollment (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, benign prostate neoplasm/hyperplasia, or malignancy that in the opinion of the Investigator, with concurrence with the Sponsor's Medical Monitor, is considered cured with minimal risk of recurrence within 3 years before the date of enrollment). History of hematopoietic allogenic transplantation.

All brain metastases have been treated locally and are clinically stable for at least 4 weeks prior to the start of treatment.

No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable).

Participants with diarrhea (liquid stool) or ileus Grade more than (>) 1 within 1 week of Cycle1Day1.

Trial design

Treatments tested in this trial

  • M7437
  • M7437

Treatment groups

138 Participants
are divided into 2 treatment groups

Locations

9
Canada
Princess Margaret Cancer Centre Toronto Canada
BC Cancer - Vancouver - BC Cancer Agency Vancouver Canada
Japan
National Cancer Center Hospital Tokyo Japan
Spain
Hospital Universitari Vall d'Hebron - VHIO - Oncology - Phase I Unit08035, Barcelona Spain

Sponsors and collaborators

EMD Serono Research & Development Institute, Inc.

Lead sponsor

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Collaborator