MT2025-14: A Phase 1a/1b Study of GTB-5550, a Camelid Nanobody TriSpecific Killer Engager (camB7-H3 TriKE®), in Select Advanced Solid Tumors That Failed Prior Therapy
Masonic Cancer Center, University of Minnesota
Summary
This is a first-in-human Phase 1a/1b trial of a B7-H3-targeted natural killer (NK) cell engager, referred to as a TriSpecific Killer Engager (TriKE), for the treatment of select solid tumor cancers. To be considered for the study, a patient must be 18 years or older, have histologically or cytologically confirmed advanced/metastatic cancer that, based on literature reports, expresses B7-H3 at a high frequency, measurable disease by RECIST 1.1 (exception: mCRPC limited to bone metastasis are exempt from this requirement), meets the disease specific criteria for prior failed therapy, and refractory to, intolerant of, or ineligible for therapy options that are known to provide clinical benefit for their diagnosis.
Description
Enrollment is limited to the following tumor types: * castration-resistant prostate cancer (CRPC) * breast cancer (any ER/PR or HER2 status) * pancreatic cancer * non-small cell lung cancer (NSCLC) * squamous cell carcinoma of the head and neck (SCCHN), including molecularlyconfirmed FA patients * epithelial ovarian cancer (OC), including fallopian tube and primary peritoneal cancer * bladder (urothelial) cancer (UC) * Prostate cancer requires failing at least one line of prior therapy in the castrate resistant setting. * SCCHN patients with a molecularly-confirmed diagnosis of FA are permitt…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Measurable disease per RECIST 1.1. (Exception: mCRPC limited to bone metastasis is exempt from this requirement). * Age 18 years or older at the time of consent, ECOG Performance Status 0 to 2 * Acute effects of any prior therapy must have resolved to baseline or Grade ≤ 1 NCI CTCAE v5 except for AEs not constituting a safety risk in the opinion of the enrolling Investigator. * Adequate organ function within 14 days (30 days for cardiac) of Cycle 1 Day 1 defined as: * Hematologic: hemoglobin ≥ 9 g/dL (may be transfused not more than 2 units of pRBCs within 7 days prior t…
Interventions
- DrugGTB-5550
GTB-5550 is given as a subcutaneous (SQ) injection in the abdominal area at the patient-assigned dose once a day for 5 consecutive days for 2 weeks in a row (i.e. Day 1-5 and Day 8-12) followed by 2 weeks of no treatment. This 4-week period equals 1 treatment cycle, or 28 days. Starting with Cycle 2 and beyond, this will be repeated with three times per week dosing for weeks 1 and 2 of the cycle (but not on 3 consecutive days) followed by 2 weeks of no treatment.
Location
- Masonic Cancer Center at University of MinnesotaMinneapolis, Minnesota