OncoMatch

OncoMatch/Clinical Trials/NCT04855435

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

Is NCT04855435 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including MBS8(1V270) and MBS8(1V270) and pembrolizumab combination for advanced solid tumor.

Phase 1RecruitingMonTa Biosciences ApSNCT04855435Data as of May 2026

Treatment: MBS8(1V270) · MBS8(1V270) and pembrolizumab combinationThe 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)

Check if I qualify

Extracted eligibility criteria

Cancer type

Tumor Agnostic

Melanoma

Disease stage

Required: Stage IV

Metastatic disease required

advanced and with progression; measurable disease according to RECIST v1.1

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: pembrolizumab (pembrolizumab)

Prior exposure to pembrolizumab for ≥6 months, with radiologic evidence of an initial decrease in measurable tumour burden, and subsequent disease progression following that period of initial tumour control (Cohort A)

Must have received: tebentafusp (tebentafusp)

Prior tebentafusp exposure with subsequent progression. ≥16 weeks of exposure to tebentafusp with documented radiological tumour reduction in at least 1 lesion. RECIST v1.1 progression on tebentafusp. (Cohort B)

Cannot have received: systemic immunotherapy (except pembrolizumab)

Any prior exposure to systemic or IT immunotherapy, except pembrolizumab, including Montanide, TLR7, TLR8, and TLR9 agonists, polyinosinic:polycytidylic acid, cationic adjuvant formulation, and messenger ribonucleic acid -based vaccines.

Cannot have received: experimental anti-cancer vaccines

Participants who have been previously treated with experimental anti-cancer vaccines.

Cannot have received: pembrolizumab and T cell combination therapy

Prior exposure to pembrolizumab and T cell combination therapy (Cohort A)

Cannot have received: biologic, hormonal, anti-neoplastic chemotherapy, or radiation therapy

Exception: except for medications with half-lives <5.5 days

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.

Cannot have received: investigational agent

Use of investigational agent in the 4 weeks or 5 half-lives prior to the first dose of MBS8(1V270), whichever was shortest.

Lab requirements

Blood counts

Haemoglobin ≥5.6 mmol/L (≥90 g/dL) (without transfusion or erythropoietin therapy within 4 weeks prior to therapy); Neutrophils ≥1.5×10⁹/L, without growth factor stimulation within 3 weeks prior to the blood test; Platelet count ≥75×10⁹/L. Stage II: Absolute neutrophil count ≥1.5×10⁹/L; platelets ≥100×10⁹/L; haemoglobin ≥9 g/dL (transfusion allowed per site's policy)

Kidney function

Serum creatinine ≤1.25×ULN or creatinine clearance ≥50 mL/min (by CKD-EPI formula); Stage II: Creatinine clearance ≥50 mL/min (Cockcroft-Gault or measured)

Liver function

AST and ALT ≤2.5×ULN; (5×ULN in the case of liver metastases); bilirubin ≤1.5×ULN except in the case of Gilbert's syndrome and 2×ULN in the case of liver metastases. Stage II: Aspartate transaminase/ALT ≤3×ULN (≤5×ULN in case of liver metastases); Total bilirubin ≤1.5×ULN (≤3×ULN in case of Gilbert's syndrome)

Cardiac function

Adequate cardiopulmonary function required; QTcF ≤500 ms

Adequate bone marrow, cardiopulmonary, renal and hepatic functions (see details in criteria); Stage II: Adequate organ function within 7 to 14 days prior to Day 1.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

Check if I qualify