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

Last updated: October 16, 2024
Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

SSGJ-705

Clinical Study ID

NCT06390774
SSGJ-705-CA-Ⅰ-01
  • Ages 18-75
  • All Genders

Study Summary

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

Inclusion

Inclusion Criteria:

  1. Males and/or females over age 18

  2. Histologically and/or cytologically documented local advanced or recurrent ormetastatic malignancies

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

  4. Expected survival >3 months.

  5. Signed informed consent form.

  6. Must have adequate organ function.

Exclusion

Exclusion Criteria:

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

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

  3. Symptomatic central nervous system metastasis.

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

  5. Severe dyspnea at rest due to complications of advanced malignant tumors, or needingsupplemental oxygen therapy.

  6. Participated in any clinical study of medical devices or drugs within 1 month priorto screening (excluding non-intervention clinical studies or follow-up period ofintervention clinical studies) .

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Study Design

Total Participants: 180
Treatment Group(s): 1
Primary Treatment: SSGJ-705
Phase: 1
Study Start date:
May 30, 2024
Estimated Completion Date:
February 28, 2027

Study Description

This study includes 4 Parts: Part 1 (dose escalation and dose extension for QW administration), Part 2 (dose escalation and dose extension for Q2W administration), Part 3 (dose escalation and dose extension for Q3W administration), and Part 4 (indication extension, such as HER2 expression, PD-L1 high expression, driver gene negative newly treated advanced NSCLC, or other tumors).

Connect with a study center

  • Affiliated Cancer Hospital of Shandong First Medical University

    Jinan, Shandong
    China

    Active - Recruiting

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