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Phase I/II Study of SCTB39G in Advanced Solid Tumours

ConditionAdvanced Malignant Solid Tumor
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSinocelltech Ltd.

About this trial

This study aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB39G 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 volunteers

Qualifiers

1.Voluntarily sign the informed consent form (ICF);

2.Male or female, ≥ 18 years and ≤ 70 years old;

3.Survival duration more than 3 months;

4.ECOG score ≤ 1 point;

Disqualifiers

1.Has participated in another clinical study within 4 weeks prior to the first dose;

2.Other malignancies diagnosed within 1 years prior to the enrollment;

3. Participants with brainstem, meningeal, spinal metastases, or compression; active central nervous system metastases;

4.NSCLC at high risk of bleeding; Obvious invasion of tumor into adjacent organs of esophageal lesions leads to high risk of bleeding or fistula,or participants after endotracheal stent implantation;

Trial design

Design model

Single group

Treatments tested in this trial

  • SCTB39G

    Drug

    SCTB39G,IV

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: SCTB39GExperimental 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 21
2

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 years

Secondary 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 years
2

Progression-free survival (PFS)

Progression-free survival is defined as the time from the start of treatment with SCTB39G until the first documentation of disease progression or death due to any cause, whichever occurs first.

Time frame
Up to 2 years
3

Overall survival (OS)

Overall survival is defined as the time from the start of treatment with SCTB39G until death due to any cause.

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

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

Sinocelltech Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: