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A Phase I Study of SSGJ-612 in Patients With Advanced Solid Tumors

ConditionAdvanced Malignant Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShenyang Sunshine Pharmaceutical Co., LTD.

About this trial

This study is an open-label phase I study to evaluate the safety, pharmacokinetics, and antitumor activity of SSGJ-612 in patients with advanced malignant solid tumors expressing HER2.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily participate in this study, be willing to follow and complete all trial procedures, and sign the informed consent form;

Aged ≥18 and ≤75 years old at the time of signing the ICF, regardless of gender;

Expected survival ≥3 months;

Performance status (PS) score of 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale;

Disqualifiers

Presence of brainstem, meninges, or spinal cord metastasis, or spinal cord compression;

Presence of active central nervous system (CNS) metastatic lesions;

Individuals with clinical symptoms or requiring repeated drainage (once a month or more frequently) of pleural effusion, pericardial effusion, or ascites;

Primary or secondary immunodeficiency, including positive human immunodeficiency virus (HIV) test;

Trial design

Design model

Single group

Treatments tested in this trial

  • SSGJ-612

    Drug

    Intravenous injection

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: SSGJ-612Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence and severity of Adverse Events (AEs)

Adverse Events (AEs) refers to all adverse medical events that occur in patients after they receive the investigational drug and do not necessarily have a causal relationship with the investigational drug. AEs were evaluated according to CTCAE V5.0.

Time frame
Through study completion, an average of 1 year
2

Incidence of DLT

Dose-Limiting Toxicity

Time frame
14 days

Secondary outcomes

1

ORR assessed by investigators per RECIST v1.1

Objective Response Rate (ORR) is the proportion of patients with Complete Response (CR) or Partial Response (PR), assessed by investigators per RECIST v1.1.

Time frame
Through study completion, an average of 1 year
2

DoR assessed by investigators per RECIST v1.1

Duration of Response (DoR) is the time between the first onset of CR or PR and the first onset of Disease Progression (PD) (assessed by investigators per RECIST v1.1) or death from any cause.

Time frame
Through study completion, an average of 1 year
3

DCR assessed by investigators per RECIST v1.1

Disease Control Rate (DCR) is the proportion of patients with CR, PR, and Stable Disease (SD), assessed by investigators per RECIST v1.1.

Time frame
Through study completion, an average of 1 year
4

TTR assessed by investigators per RECIST v1.1

Time to Response (TTR) is the time from the start of treatment until the date of first documented response (assessed by investigators per RECIST v1.1).

Time frame
Through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

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

Shenyang Sunshine Pharmaceutical Co., LTD.

Lead sponsor

Source ClinicalTrials.gov
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