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Not yet recruitingNCT07815002Updated Sep 11, 2026

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

A Phase 1 interventional study of 3SC009 in Advanced Solid Tumors Patients, sponsored by Shenyang Sunshine Pharmaceutical Co., LTD.. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by Shenyang Sunshine Pharmaceutical Co., LTD. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
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Study summary

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.

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Conditions studied

  • Advanced Solid Tumors Patients

Keywords

  • Solid Tumors
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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Known uncontrolled or symptomatic central nervous system metastatic disease.
  2. 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).
  3. Inadequate organ or bone marrow function.
  4. Pregnant or breast-feeding woman.
  5. 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.
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    different doses of 3SC009

    different dose levels of 3SC009

    Drug: 3SC009

Interventions

  • Drug3SC009

    A CD47/EpCAM bispecific antibody

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What researchers measure

Primary outcomes

  1. Number of participants with adverse events (AEs)

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

  2. Number of participants with DLTs

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

Secondary outcomes

  1. The blood concentration of 3SC009

    Time frame: 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)

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

  3. Objective response rate (ORR)

    Time frame: Up to 2 years

  4. Disease control rate (DCR)

    Time frame: Up to 2 years

  5. Progression-free survival (PFS)

    Time frame: Up to 2 years

  6. Overall survival (OS)

    Time frame: Up to 2 years

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT07815002
Lead sponsor
Shenyang Sunshine Pharmaceutical Co., LTD.
Responsible party
Sponsor
First posted
Sep 11, 2026
Start date
Sep 30, 2026 (estimated)
Primary completion
Mar 30, 2028 (estimated)
Completion
Sep 30, 2028 (estimated)
Last update
Sep 11, 2026

Study contacts

Yongchang Zhang
Contact
zhangyongchang@csu.edu.cn
13873123436

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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