Advanced Malignant Solid TumorPhase 1/2NCT07050641
Phase I/II Study of SCTB39-1 in Advanced Solid Tumours
A Phase 1/2 study testing SCTB39-1 in people with Advanced Malignant Solid Tumor, run by Sinocelltech Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Solid Tumor
- What is being tested?
- SCTB39-1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 23 Jun 2025to 30 Jun 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, over 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;
- At least one measurable tumor lession according to RECIST v1.1;
- Adequate organ and bone marrow function.
Who cannot join
- 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;
- Presence of pleural effusion, peritoneal effusion, or ascites;
- History of permanent discontinuation of immunotherapy due to immune-related toxicity or occurrence of ≥ Grade 3 irAEs;
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- Presence of any active autoimmune disease or a history of autoimmune disease with an expected recurrence;
- History of severe allergies, severe drug allergies (including unapproved investigational drugs);
- History of organ transplantation or stem cell transplantation;
- Need for immunosuppressive drugs within 2 weeks prior to enrollment or anticipated during the study;
- Received chemotherapy, immunotherapy, biologic therapy, or other anti-tumor treatments within 4 weeks before enrollment;
- Pregnant or breastfeeding female.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Science
Beijing
Yu Hua, +86-18810090438, tsjj0082@chncro.com
About this study
Official title: An Open Multi-center Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SCTB39-1 in Adult Patients With Advanced Malignant Solid Tumours
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.
- Conditions
- Advanced Malignant Solid Tumor
- Being tested
- SCTB39-1
- Keywords
- advanced malignant solid tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCTB39-1Drug
SCTB39-1, IV
| Study group | Role | What they receive |
|---|---|---|
| SCTB39-1 | Experimental | SCTB39-1 of different doses, IV, every 3 weeks Receives: Drug: SCTB39-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting toxicity(DLT)
Incidence of dose-limiting toxicities up to the Day 21 visit
Measured: From Day 0 up to Day 21
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)
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
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.
Measured: Up to 2 years
Overall survival (OS)
Overall survival is defined as the time from the start of treatment with SCTB39-1 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.
- First posted3 Jul 2025
- Study start23 Jun 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant Solid TumorStudies of the same condition, open and under way.
- More trials run by Sinocelltech Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinocelltech Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07050641
- Sponsor's protocol ID
- SCTB39-1-X201
- Status last verified
- Jul 2025
- First submitted
- 25 Jun 2025
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Multi-center Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SCTB39-1 in Adult Patients With Advanced Malignant Solid Tumours
- ClinicalTrials.gov ID
- NCT07050641
- Acronym / sponsor ID
- SCTB39-1-X201
- Conditions
- Advanced Malignant Solid Tumor
- Keywords
- advanced malignant solid tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Sinocelltech Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCTB39-1 | Experimental | Drug: SCTB39-1SCTB39-1 of different doses, IV, every 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Voluntarily sign the informed consent form (ICF);
- Male or female, over 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;
Key exclusion criteria (12 listed)
- 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;
- Presence of pleural effusion, peritoneal effusion, or ascites;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCTB39-1SCTB39-1, IV | Drug | SCTB39-1 |
Primary outcome
Dose-Limiting toxicity(DLT)
Time frame: From Day 0 up to Day 21
Incidence of dose-limiting toxicities up to the Day 21 visit
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.
3 secondary outcomes
Disease control rate (DCR)
Time frame: Up to 2 years
Progression-free survival (PFS)
Time frame: Up to 2 years
Overall survival (OS)
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SCTB39-1 in people with Advanced Malignant Solid Tumor, 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 8 inclusion and 12 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 4 Jul 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 Cuige Gao (+86-10-58628288, cuige_gao@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?
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 4 Jul 2025.