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Advanced Solid Tumors PatientsPhase 1NCT07815002

Phase I Clinical Study to Evaluate the Safety and Efficacy of 3SC009 Monotherapy for Patients With Advanced Solid Tumors

A Phase 1 study testing 3SC009 in people with Advanced Solid Tumors Patients, run by Shenyang Sunshine Pharmaceutical Co., LTD..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This study includes two parts, different part has different administration frequencies of 3SC009. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumors Patients
What is being tested?
3SC009
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
30 Sep 2026to 30 Sep 2028
Phase
Phase 1
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males and/or females over age 18
  • Histologically and/or cytologically documented advanced or metastatic Solid Tumors .
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Expected survival >=3 months.
  • Signed informed consent form.

Who cannot join

  • Known uncontrolled or symptomatic central nervous system metastatic disease.
  • Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade >1 (National Cancer Institute Common terminology Criteria [NCI CTCAE] v.6.0).
  • Inadequate organ or bone marrow function.
  • Pregnant or breast-feeding woman.
  • Known allergies, hypersensitivity, or intolerance to 3SC009 The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Yongchang Zhang contact

13873123436

zhangyongchang@csu.edu.cn

About this study

Official title: Phase I Clinical Study to Evaluate the Safety, Tolerability, and Initial Efficacy of 3SC009 Monotherapy for Patients With Advanced Solid Tumors

This study includes two parts, different part has different administration frequencies of 3SC009.

Read the detailed description

3SC009 is a bispecific antibody targeting EpCAM and CD47. This study is a study of 3SC009 monotherapy in advanced Solid Tumors. This study includes two parts, different part has different administration frequencies of 3SC009. The first Part is Q2W and Second part is QW. Each part will assess the efficacy and safety of the preset several dose levels of 3SC009 in advanced Solid Tumors.

Being tested
3SC009
Keywords
Solid Tumors

What participants receive

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

  • 3SC009Drug

    A CD47/EpCAM bispecific antibody

Study groups in NCT07815002
Study groupRoleWhat they receive
different doses of 3SC009Experimentaldifferent dose levels of 3SC009
Receives: Drug: 3SC009

What is being measured

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

  1. Number of participants with adverse events (AEs)

    Measured: From the first dose of 3SC009 until 28 days after last dose of 3SC009

  2. Number of participants with DLTs

    Measured: At the end of Cycle 1 (up to 14 days)

Secondary outcomes (6)

  1. The blood concentration of 3SC009

    Measured: From first dose of 3SC009 through 28 days after last dose of 3SC009

  2. The incidence of Anti-drug antibody(ADA) and Neutralizing antibody(Nab)

    Measured: From first dose of 3SC009 through 28 days after last dose of 3SC009

  3. Objective response rate (ORR)

    Measured: Up to 2 years

  4. Disease control rate (DCR)

    Measured: Up to 2 years

  5. Progression-free survival (PFS)

    Measured: Up to 2 years

  6. Overall survival (OS)

    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 posted11 Sep 2026
  2. Study start30 Sep 2026 (estimated)
  3. Primary completion30 Mar 2028 (estimated)
  4. Study completion30 Sep 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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07815002
Sponsor's protocol ID
3SC009-101
Status last verified
Jun 2026
First submitted
18 Aug 2026
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 3SC009 in people with Advanced Solid Tumors Patients, run by Shenyang Sunshine Pharmaceutical Co., LTD..

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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

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 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.

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 Yongchang Zhang (13873123436, zhangyongchang@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse events (AEs) (time frame: From the first dose of 3SC009 until 28 days after last dose of 3SC009). 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 NCT07815002.

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 11 Sep 2026.

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