Targeting Pancreatic Cancer and other CA19-9 expressing tumors
We initiated the MVT-5873 therapeutic antibody phase I clinical trial in February 2016 to evaluate the safety, tolerability and pharmacokinetics of the antibody as a single agent or in combination with the current standard of care chemotherapy regimen in subjects with pancreatic cancer or other CA19-9 expressing tumors. The monotherapy portion of the trial is enrolling stage 3 or 4 pancreatic cancer patients who have failed all other treatments and have progressive disease. The combination therapy trial is enrolling newly diagnosed treatment naïve patients.
|MVT-5873 Therapeutic Metastatic Pancreatic & GI Cancers||NIH, MSKCC, SCRI, Patheon||
Discovery Phase complete
Pre-IND Phase complete
Phase 1 Phase in progress
|Commercial Rights: WW|
The objectives of the trial include:
- Determination of safety and tolerability as a single agent and in combination with chemotherapy as first line therapy
- Determination of recommended Phase 2 dose for both single agent and combination therapy
- Determination of pharmacokinetics of MVT-5873
- Evaluate tumor response rate (RECIST 1.1) and duration of response
Clinical Trials Results
- Twenty-five patients have been treated to date and twenty-two were evaluable. Patients enrolled have stage 3 or 4 pancreatic cancer with progressive disease who have failed all previous therapies and receive only MVT-5873 as monotherapy.
- Of the twenty-two patients treated to date who are evaluable and receiving only MVT-5873, seven patients (32%) have demonstrated conversion from progressive disease to stable disease via RESIST 1.1 assessment at the end of the fourth cycle of treatment or 112 days on therapy. To date, three patients (14%) have continued to demonstrate stable disease at the end of the sixth cycle or 168 days of treatment.
- After administration of MVT-5873 (1 to 2 mg/kg) circulating levels of antigen CA19-9 are reduced >80% or below normal levels (<37 U/mL).
- Adverse effects have included infusion reactions which are addressed by slowing the rate of infusion as well as prophylactic administration of routine medications. Transient elevated liver function tests have been observed at higher dosages that normalize in most cases before the second dose.