CClinicalTrials.gg
RecruitingNCT06600022Updated Jan 16, 2025

Aims to Explore the Safety, Tolerability, and Preliminary Efficacy of SCTB41 in Adult Patients with Advanced Malignant Solid Tumours.

A Phase 1/2 interventional study of SCTB41 in Advanced Malignant Solid Tumours, sponsored by Sinocelltech Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-16.

Sponsored by Sinocelltech Ltd. · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2024; still recruiting 1 year 11 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
441
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

This study aims to explore the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB41 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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Conditions studied

  • Advanced Malignant Solid Tumours

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03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 441 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Sinocelltech Ltd. is the lead sponsor of 78 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Voluntarily sign the informed consent form (ICF);
  2. Male or female, ≥18 years old;
  3. Survival duration more than 3 months;
  4. ECOG score ≤ 1 point;
  5. Participants in Phase Ia (dose-escalation phase) are required to meet the following criteria: histologically or cytologically confirmed diagnosis of advanced malignant solid tumour;
  6. Participants in Phase Ib (dose-expansion phase) and Phase II are required to meet the following criteria: Histologically or cytologically confirmed specific type advanced malignant solid tumours;
  7. Adequate organ and bone marrow function.

Exclusion criteria

Exclusion Criteria:

  1. Participants with brainstem, meningeal, spinal metastases, orcompression; active central nervous system metastases;
  2. Other malignancies diagnosed;
  3. History of hypertensive crisis or hypertensive encephalopathy; presence of uncontrolled hypertension. History of arterial thrombosis or deep veinthrombosis within 6 months prior to enrollment;
  4. Presence of any active autoimmune disease or a history of autoimmunedisease with an expected recurrence;
  5. Received chemotherapy, immunotherapy, biologic therapy, or other antitumor treatments within 4 weeks before enrollment;
  6. Need for immunosuppressive drugs within 2 weeks prior to enrollment oranticipated during the study;
  7. Significant coagulopathy or other evident risk of bleeding;
  8. uncontrolled effusions in the serous cavities within 4 weeks before enrollment;
  9. Major surgery or significant trauma within 4 weeks prior to enrollment;presence of unhealed skin wounds, surgical sites, trauma sites, severe- Page 3 of 4 [DRAFT] -mucosal ulcers, or fractures, or if the Investigator deems the participantunsuitable for the study;
  10. History of permanent discontinuation of immunotherapy due to immunerelated toxicity or occurrence of ≥ Grade 3 irAEs;
  11. Known severe allergy to similar antibody drugs;
  12. Presence of active infection;
  13. History of organ transplantation or stem cell transplantation;
  14. Pregnant or breastfeeding female; women of childbearing potential withpositive pregnancy test within 7 days before the enrollment; participants(including males of childbearing potential and their female partners, and females of childbearing potential and their male partners) unwilling to use medically recognized effective contraception during the study and for 6 months after treatment ends.
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
441 participants (estimated)

Study arms

  • Experimental
    Arms

    SCTB41 of different doses,IV,every 3 weeks

    Drug: SCTB41

Interventions

  • DrugSCTB41

    SCTB41 of different doses,IV,every 3 weeks

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What researchers measure

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 SCTB41 until the first documentation ofdisease 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 SCTB41 until death due to any cause.

    Time frame: Up to 2 years

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Study locations

1 of 1 sites recruiting
  • Sun Yat-sen University Cancer Center
    Guangzhou, Guangdong 510060, China
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06600022
Lead sponsor
Sinocelltech Ltd.
Responsible party
Sponsor
First posted
Sep 19, 2024
Start date
Oct 10, 2024
Primary completion
Apr 30, 2027 (estimated)
Completion
Apr 30, 2028 (estimated)
Last update
Jan 16, 2025

Study contacts

xiaoman zhang
Contact
xiaoman_zhang@sinocelltech.com
+86-10-58628288-9134

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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