OncoMatch/Clinical Trials/NCT04855435
Safety and Preliminary Efficacy of MBS8(1V270) in Cancer Patients With Advanced Solid Tumours
Is NCT04855435 recruiting? Yes, currently enrolling (Sep 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
Treatments studied
Immunotherapy
Other
Cancer type
Tumor Agnostic
Melanoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic anti-cancer therapy
Prior systemic anti-cancer therapy with a washout period of ≥14 days plus resolution of drug-related AEs before C1D1
Cannot have received: systemic or intratumoral immunotherapy (Montanide, TLR7 agonists, TLR8 agonists, TLR9 agonists, polyinosinic:polycytidylic acid, cationic adjuvant formulation, messenger ribonucleic acid-based vaccines, T cell therapy, oncolytic viruses)
Exception: except tebentafusp, pembrolizumab, nivolumab, ipilimumab, and relatlimab
Any prior exposure to systemic or IT immunotherapy (except tebentafusp, pembrolizumab, nivolumab, ipilimumab, and relatlimab), but including Montanide, TLR7, TLR8, and TLR9 agonists, polyinosinic:polycytidylic acid, cationic adjuvant formulation, messenger ribonucleic acid -based vaccines, T cell therapy, and oncolytic viruses
Cannot have received: experimental anti-cancer vaccines
Participants who have been previously treated with experimental anti-cancer vaccines
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. 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). 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. 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
No clinically significant cardiac disease, including: Known congestive heart failure Grade III or IV by NYHA, myocardial infarction within 6 months prior to signing the ICF, onset of unstable angina within 6 months prior to signing the ICF. QTcF ≤500 ms.
Adequate bone marrow, cardiopulmonary, renal and hepatic functions: ... see inclusion criteria 8 and Stage II General Inclusion Criteria 4. QTcF >500 ms [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT04855435 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic or intratumoral immunotherapy, experimental anti-cancer vaccines disqualifies patients from enrollment.
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 qualifyRelated pages