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NCT Number: NCT07077252

Phase I/II Study of SCTB39G in Advanced Solid Tumours

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100412, China

Location contact

Lin Shen, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • 5.histologically or cytologically confirmed diagnosis of advanced malignant solid tumour;
  • 6.At least one measurable tumor lession according to RECIST v1.1;
  • 7.Adequate organ and bone marrow function.

Exclusion criteria

  • 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;
  • 5.Participants with portal hypertension due to portal vein tumor thrombus at risk of bleeding;
  • 6.Presence of pleural effusion, peritoneal effusion, or ascites;
  • 7.Received chemotherapy, immunotherapy, biologic therapy, or other antitumor treatments within 4 weeks before enrollment
  • 8.History of permanent discontinuation of immunotherapy due to immune-related toxicity or occurrence of ≥ Grade 3 irAEs;
  • 9.Presence of any active autoimmune disease or a history of autoimmune disease with an expected recurrence;
  • 10.History of severe allergies, severe drug allergies (including unapproved investigational drugs);
  • 11.History of organ transplantation or stem cell transplantation;
  • 12.Need for immunosuppressive drugs within 2 weeks prior to enrollment or anticipated during the study;
  • 13.Pregnant or breastfeeding female.

Treatment and study plan

SCTB39G

Drug

SCTB39G,IV

Primary outcomes

  1. Dose-Limiting toxicity(DLT)

    Time frame: From Day 0 up to Day 21

    Incidence of dose-limiting toxicities up to the Day 21 visit

  2. Objective response rate (ORR)

    Time frame: Up to 2 years

    The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1

Secondary outcomes

  1. Disease control rate (DCR)

    Time frame: Up to 2 years

    The DCR is defined as the proportion of subjects with CR, PR, or SD based on RECIST Version 1.1.

  2. Progression-free survival (PFS)

    Time frame: Up to 2 years

    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.

  3. Overall survival (OS)

    Time frame: Up to 2 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Sinocelltech Ltd.

Industry

Registry information

Official study title

An Open Multi-center Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SCTB39G in Adult Patients With Advanced Malignant Solid Tumours

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 22, 2025
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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