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

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

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07815002

Enrollment

100

Registered

2026-09-11

Start date

2026-09-30

Completion date

2028-09-30

Last updated

2026-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumors Patients

Keywords

Solid Tumors

Brief summary

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

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.

Interventions

DRUG3SC009

A CD47/EpCAM bispecific antibody

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Contacts

CONTACTYongchang Zhang

zhangyongchang@csu.edu.cn13873123436

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 12, 2026