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.
Treatment: MBS8(1V270) · MBS8(1V270) and pembrolizumab combination — 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)
Check if I qualifyExtracted 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.
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