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Safety and Preliminary Efficacy of MBS8(1V270) in Cancer Patients With Advanced Solid Tumours

ConditionsAdvanced Solid TumorUveal Melanoma, MetastaticCutaneous Melanoma
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • MBS8(1V270)

    Drug

    MBS8(1V270) monotherapy

  • MBS8(1V270) and pembrolizumab combination

    Drug

    MBS8(1V270) and pembrolizumab combination

Treatment groups

106 Participants
are divided into 2 treatment groups
Group A: MBS8(1V270)Experimental treatment 1 intervention
Group B: MBS8 (1V270) + pembrolizumabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse events

Type and number of adverse events

Time frame
42 days
2

Dose limiting toxicities

Dose limiting toxicities (DLTs) and the MTD for determination of RP2D of MBS8(1V270). Stage I only

Time frame
23 days
3

Safety related biomarkers

Plasma levels of safety related cytokines IL-6 and TNF-alpha wil be assessed

Time frame
23 days

Secondary outcomes

1

Best overall response

Complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), unconfirmed (iUPD) and confirmed PD (iCPD), assessed according to Response Evaluation Criteria in Solid Tumours (RECIST) and immune RECIST (iRECIST

Time frame
42 days
2

Pharmacokinetic profile of drug substance

The plasma concentration time profile of MBS8(1V270) will be assessed

Time frame
22 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

MonTa Biosciences ApS

Lead sponsor

Source ClinicalTrials.gov
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