A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SSGJ-705 Monotherapy in Patients with Advanced Malignant Tumors
Recruiting now · Phase 1
Conditions studied: Locally Advanced, Recurrent or Metastatic Malignancies
In brief
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.
Key facts
- Study ID
- NCT06390774
- Run by
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
- People needed
- 180
- Starts
- 2024-05-30
- Expected to finish
- 2027-02-01
- Last updated by the study team
- 2024-10-18
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
- Signed informed consent form.
- Must have adequate organ function.
You may not qualify if…
- 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.
- Severe dyspnea at rest due to complications of advanced malignant tumors, or needing supplemental oxygen therapy.
- 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.
Where it is running
- Affiliated Cancer Hospital of Shandong First Medical University — Jinan, Shandong, China (enrolling)
Full record on ClinicalTrials.gov
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