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Trial Title:
A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SSGJ-705 Monotherapy in Patients with Advanced Malignant Tumors
NCT ID:
NCT06390774
Condition:
Locally Advanced, Recurrent or Metastatic Malignancies
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
advanced malignancies
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SSGJ-705
Description:
anti-PD-1 and anti-HER2 bispecific antibody
Arm group label:
Part 1
Arm group label:
Part 2
Arm group label:
Part 3
Arm group label:
Part 4
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.
Detailed 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).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Males and/or females over age 18
2. Histologically and/or cytologically documented local advanced or recurrent or
metastatic 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 Criteria:
1. 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.
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 needing
supplemental oxygen therapy.
6. Participated in any clinical study of medical devices or drugs within 1 month prior
to screening (excluding non-intervention clinical studies or follow-up period of
intervention clinical studies) .
The above information was not intended to contain all considerations relevant to a
participant's potential participation in a clinical trial.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Affiliated Cancer Hospital of Shandong First Medical University
Address:
City:
Jinan
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhaowei Li
Phone:
0531-67626929
Email:
sdzlllh803@126.com
Start date:
May 30, 2024
Completion date:
February 2027
Lead sponsor:
Agency:
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Agency class:
Industry
Source:
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06390774
