Phase I Clinical Study to Evaluate the Safety and Efficacy of SSGJ-706 Monotherapy for Patients With Advanced Solid Tumors
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
This study includes two parts, different part has different administration frequencies of SSGJ-706.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2024
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 29, 2024
CompletedFirst Posted
Study publicly available on registry
August 1, 2024
CompletedStudy Start
First participant enrolled
August 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2025
CompletedAugust 1, 2024
April 1, 2024
12 months
July 29, 2024
July 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
DLTs
Dose limiting toxicity
12 months
MTD or MAD
maximum tolerated dose or the maximum administered dose if MTD is not reached
12 months
Secondary Outcomes (1)
The blood concentration of SSGJ-706
12 months
Study Arms (12)
Arm 1
EXPERIMENTALdose level 1 of SSGJ-706
Arm 2
EXPERIMENTALdose level 2 of SSGJ-706
Arm 3
EXPERIMENTALdose level 3 of SSGJ-706
Arm 4
EXPERIMENTALdose level 4 of SSGJ-706
Arm 5
EXPERIMENTALdose level 5 of SSGJ-706
Arm 6
EXPERIMENTALdose level 6 of SSGJ-706
Arm 7
EXPERIMENTALdose level 1 of SSGJ-706
Arm 8
EXPERIMENTALdose level 2 of SSGJ-706
Arm 9
EXPERIMENTALdose level 3 of SSGJ-706
Arm 10
EXPERIMENTALdose level 4 of SSGJ-706
Arm 11
EXPERIMENTALdose level 5 of SSGJ-706
Arm 12
EXPERIMENTALdose level 6 of SSGJ-706
Interventions
Eligibility Criteria
You may qualify if:
- Males and/or females over age 18
- Histologically and/or cytologically documented advanced or metastatic Solid Tumors .
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Expected survival \>=3 months.
- Signed informed consent form.
You may not qualify if:
- Known uncontrolled or symptomatic central nervous system metastatic disease.
- Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade \>1 (National Cancer Institute Common terminology Criteria \[NCI CTCAE\] v.5.0).
- Inadequate organ or bone marrow function.
- Pregnant or breast-feeding woman.
- Known allergies, hypersensitivity, or intolerance to SSGJ-706 The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2024
First Posted
August 1, 2024
Study Start
August 1, 2024
Primary Completion
July 30, 2025
Study Completion
August 31, 2025
Last Updated
August 1, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share