A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SSGJ-705 Monotherapy in Patients with Advanced Malignant Tumors
NCT ID: NCT06390774
Last Updated: 2024-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
180 participants
INTERVENTIONAL
2024-05-30
2027-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Part 1
Dose escalation will be conducted using a traditional 3+3 design. Dose Escalation includes 6 levels, QW IV. Dose extension will be carried out at the selected level.
SSGJ-705
anti-PD-1 and anti-HER2 bispecific antibody
Part 2
Dose escalation will be conducted using a traditional 3+3 design. Dose Escalation includes 6 levels, Q2W IV. Dose extension will be carried out at the selected level.
SSGJ-705
anti-PD-1 and anti-HER2 bispecific antibody
Part 3
Dose escalation will be conducted using a traditional 3+3 design. Dose Escalation includes 6 levels, Q3W IV. Dose extension will be carried out at the selected level.
SSGJ-705
anti-PD-1 and anti-HER2 bispecific antibody
Part 4
Indication extension will be carried out at the selected level，including 3 dosage levels.
SSGJ-705
anti-PD-1 and anti-HER2 bispecific antibody
Interventions
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SSGJ-705
anti-PD-1 and anti-HER2 bispecific antibody
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Affiliated Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SSGJ-705-CA-Ⅰ-01
Identifier Type: -
Identifier Source: org_study_id
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