A Phase 1 Study of SSGJ-709 in Patients With Advanced Malignant Tumors

ConditionAdvanced Malignant Tumors

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorShenyang Sunshine Pharmaceutical Co., LTD.

About this trial

This study is an open-label phase I study to evaluate the safety, pharmacokinetics, and anti-tumor activity of SSGJ-709 as a single agent in patients with advanced malignancies.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Minimum life expectancy of 3 months;

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

Locally advanced or metastatic malignant tumors confirmed by histopathology or cytology; preferred tumor types for enrollment include head and neck squamous cell carcinoma, non-small cell lung cancer, esophageal squamous cell carcinoma or adenocarcinoma, gastric or gastroesophageal junction adenocarcinoma, colorectal adenocarcinoma, hepatocellular carcinoma, urothelial carcinoma, and clear cell renal cell carcinoma. Subjects with other tumor types may be enrolled after discussion with the sponsor；

Subject who have failed, or has been intolerant to standard therapy, or has been considered lack standard of care for a given tumor type, and who is not able to complete surgical resection and receive curative concurrent/sequential chemoradiotherapy；

Disqualifiers

Presence of brainstem, meningeal metastases, spinal cord metastases or compression；

Presence of active central nervous system (CNS) metastases；

Subjects with pleural effusion, pericardial effusion, or ascites that are clinically symptomatic or require repeated drainage；

Subjects with other malignant tumors within 3 years prior to screening；

Trial design

Design model

Single group

Treatments tested in this trial

SSGJ-709
Drug
A bispecific antibody targeting PD-1 and LAG-3.

Treatment groups

15 Participants

are divided into 1 treatment group

Group A: Experimental: SSGJ-709Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Incidence of DLT

Dose limiting toxicity

Time frame

21 days

Incidence of Treatment-Emergent Adverse Events

TEAE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

Time frame