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

September 10, 2026 updated by: Shenyang Sunshine Pharmaceutical Co., LTD.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: different doses of 3SC009
different dose levels of 3SC009
Drug: 3SC009
A CD47/EpCAM bispecific antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events (AEs)
Time Frame: From the first dose of 3SC009 until 28 days after last dose of 3SC009
From the first dose of 3SC009 until 28 days after last dose of 3SC009
Number of participants with DLTs
Time Frame: At the end of Cycle 1 (up to 14 days)
At the end of Cycle 1 (up to 14 days)

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival (OS)
Time Frame: Up to 2 years
Up to 2 years
Progression-free survival (PFS)
Time Frame: Up to 2 years
Up to 2 years
Objective response rate (ORR)
Time Frame: Up to 2 years
Up to 2 years
Disease control rate (DCR)
Time Frame: Up to 2 years
Up to 2 years
The blood concentration of 3SC009
Time Frame: From first dose of 3SC009 through 28 days after last dose of 3SC009
From first dose of 3SC009 through 28 days after last dose of 3SC009
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
From first dose of 3SC009 through 28 days after last dose of 3SC009

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenyang Sunshine Pharmaceutical Co., LTD.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 30, 2026

Primary Completion (Estimated)

March 30, 2028

Study Completion (Estimated)

September 30, 2028

Study Registration Dates

First Submitted

August 18, 2026

First Submitted That Met QC Criteria

September 10, 2026

First Posted (Actual)

September 11, 2026

Study Record Updates

Last Update Posted (Actual)

September 11, 2026

Last Update Submitted That Met QC Criteria

September 10, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 3SC009-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe