Phase I/II Study of SCTB39-1 in Advanced Solid Tumours
ConditionAdvanced Malignant Solid Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSinocelltech Ltd.
About this trial
This study aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB39-1 as a monotherapy in adult patients with advanced malignant solid tumours. This study is an open label, multicentre, dose-escalation and dose-expansion Phase I/II clinical trial.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntarily sign the informed consent form (ICF);
Male or female, over 18 years old;
Survival duration more than 3 months;
ECOG score ≤ 1 point;
Disqualifiers
Has participated in another clinical study within 4 weeks prior to the first dose;
Other malignancies diagnosed within 5 years prior to the enrollment;
Participants with brainstem, meningeal, spinal metastases, or compression; active central nervous system metastases;
Significant bleeding risk;
Trial design
Design model
Single group
Treatments tested in this trial
SCTB39-1
DrugSCTB39-1, IV
Treatment groups
110 Participants
are divided into 1 treatment groupGroup A: SCTB39-1Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose-Limiting toxicity(DLT)
Incidence of dose-limiting toxicities up to the Day 21 visit
Time frame
From Day 0 up to Day 212
Objective response rate (ORR)
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.
Time frame
Up to 2 yearsSecondary outcomes
1
Disease control rate (DCR)
The DCR is defined as the proportion of subjects with CR, PR, or SD based on RECIST Version 1.1.
Time frame
Up to 2 years2
Progression-free survival (PFS)
Progression-free survival is defined as the time from the start of treatment with SCTB39-1 until the first documentation of disease progression or death due to any cause, whichever occurs first.
Time frame
Up to 2 years3
Overall survival (OS)
Overall survival is defined as the time from the start of treatment with SCTB39-1 until death due to any cause.
Time frame
Up to 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov