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

ConditionAdvanced Solid Tumors Patients
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShenyang Sunshine Pharmaceutical Co., LTD.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 3SC009

    Drug

    A CD47/EpCAM bispecific antibody

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: different doses of 3SC009Experimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shenyang Sunshine Pharmaceutical Co., LTD.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: