Safety and Preliminary Efficacy of MBS8(1V270) in Cancer Patients With Advanced Solid Tumours
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMonTa Biosciences ApS
About this trial
The Phase I trial is evaluating safety, tolerability, pharmacokinetics and preliminary efficacy of MBS8(1V270) in subjects with advanced solid tumours. The trial is designed to provide data for further clinical development of MBS8(1V270)
Eligibility criteria
Qualifiers
Diagnosis of a histologically or cytologically confirmed solid tumour that was advanced and with progression. No standard treatment existed, or the participant refused standard treatment. Experimental immunotherapy appeared as a feasible exploratory treatment option as per Investigator's assessment.
Tumour lesion(s) accessible to serial biopsies.
Was willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and tumour biopsies. Mandatory Baseline and on-treatment tumour biopsies were required. However, a biopsy may have been omitted if the procedure was deemed medically unsafe or not feasible, based on the Investigator's clinical judgment and after discussion with the Medical Monitor (or Sponsor's designee).
Measurable disease according to RECIST v1.1. Previously irradiated lesions were measurable if subsequent progression was documented.
Disqualifiers
Have had biologic, hormonal, anti-neoplastic chemotherapy, or radiation therapy within 4 weeks prior to Screening (6 weeks required for nitrosourea or mitomycin) except for medications with half-lives <5.5 days.
Metastatic disease that involved major airways or blood vessels or centrally located mediastinal tumour masses of large volume with close relation to the major airways, where tumour necrosis may have caused perforation or severe bleeding episodes. Primary or metastatic intestinal disease in situ where tumour necrosis may have caused gastrointestinal perforation.
Use of investigational agent in the 4 weeks or 5 half-lives prior to the first dose of MBS8(1V270), whichever was shortest.
Major surgical procedure within 14 days prior to the first dose of trial treatment.
Trial design
Treatments tested in this trial
- MBS8(1V270)
- MBS8(1V270) and pembrolizumab combination
Treatment groups
106 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov