A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SSGJ-705 Monotherapy in Patients with Advanced Malignant Tumors

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

About this trial

This study was an open-label phase I study to evaluate the safety, tolerability, PK profile and potential efficacy of SSGJ-705 as a single agent in patients with advanced malignancies.

Eligibility criteria

Qualifiers

Males and/or females over age 18

Histologically and/or cytologically documented local advanced or recurrent or metastatic malignancies

Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

Expected survival >3 months.

Disqualifiers

Any remaining AEs > grade 1 from prior anti-tumor treatment as per CTCAE v5. 0, with exception of hair loss, fatigue, and grade 2 peripheral neurotoxicity.

Pregnant or nursing women or women/men who are ready to give birth

Symptomatic central nervous system metastasis.

Allergy to other antibody drugs or any excipients in the study drugs.

Trial design

Treatments tested in this trial

  • SSGJ-705

Treatment groups

180 Participants
are divided into 4 treatment groups