Locally Advanced, Recurrent or Metastatic Malignancies
Investigational drug(s) / intervention(s)
SSGJ-705
SSGJ-705: anti-PD-1 and anti-HER2 bispecific antibody
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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
DLTs — 14 days Dose limiting toxicity
AE — up to 1 year Safety and tolerability assessed by incidence and severity of adverse events
MTD or MAD — up to 1 year maximum tolerated dose or the maximum administered dose if MTD is not reached
RP2D — up to 1 year the recommended phase II dose
Trial sites (1)
Facility
City
Region
Status
Affiliated Cancer Hospital of Shandong First Medical University
Jinan
Shandong
Recruiting
More Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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