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Advanced Malignant Solid TumoursPhase 1/2NCT06600022

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

A Phase 1/2 study testing SCTB41 in people with Advanced Malignant Solid Tumours, run by Sinocelltech Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Malignant Solid Tumours
What is being tested?
SCTB41
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
441 participants
Where
1 siteChina
Study dates
10 Oct 2024to 30 Apr 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Participants with brainstem, meningeal, spinal metastases, orcompression; active central nervous system metastases;
  • Other malignancies diagnosed;
  • History of hypertensive crisis or hypertensive encephalopathy; presence of uncontrolled hypertension. History of arterial thrombosis or deep veinthrombosis within 6 months prior to enrollment;
  • Presence of any active autoimmune disease or a history of autoimmunedisease with an expected recurrence;
  • Received chemotherapy, immunotherapy, biologic therapy, or other antitumor treatments within 4 weeks before enrollment;
  • Need for immunosuppressive drugs within 2 weeks prior to enrollment oranticipated during the study;
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  • Significant coagulopathy or other evident risk of bleeding;
  • uncontrolled effusions in the serous cavities within 4 weeks before enrollment；
  • 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;
  • History of permanent discontinuation of immunotherapy due to immunerelated toxicity or occurrence of ≥ Grade 3 irAEs;
  • Known severe allergy to similar antibody drugs;
  • Presence of active infection；
  • History of organ transplantation or stem cell transplantation;
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

xiaoman zhang contact

+86-10-58628288-9134

xiaoman_zhang@sinocelltech.com

China1 site, 1 recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Ruihua Xu, Professor, 13922206676, xurh@sysucc.org.cn

    Recruiting

Other trials in China

About this study

Official title: A Phase I/II, Open-label, Multicentre, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics and Anti-tumor Activity of SCTB41 in Patients with Advanced Malignant Solid Tumours

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.

Being tested
SCTB41

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SCTB41Drug

    SCTB41 of different doses,IV,every 3 weeks

Study groups in NCT06600022
Study groupRoleWhat they receive
ArmsExperimentalSCTB41 of different doses,IV,every 3 weeks
Receives: Drug: SCTB41

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-Limiting toxicity(DLT)

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

    Measured: :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

    Measured: Up to 2 years

Secondary outcomes (3)

  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.

    Measured: 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.

    Measured: 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.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start10 Oct 2024
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion30 Apr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
441 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06600022
Sponsor's protocol ID
SCTB41-X101
Status last verified
Oct 2024
First submitted
12 Sep 2024
Last updated
16 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SCTB41 in people with Advanced Malignant Solid Tumours, run by Sinocelltech Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact xiaoman zhang (+86-10-58628288-9134, xiaoman_zhang@sinocelltech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-Limiting toxicity(DLT) (time frame: :From Day 0 up to Day 21). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06600022.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.

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