A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SSGJ-705 Monotherapy in Patients with Advanced Malignant Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SSGJ-705.
- Who it may be relevant to
- Registry conditions: Locally Advanced, Recurrent or Metastatic Malignancies. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase I Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SSGJ-705 Monotherapy in Patients with Advanced Malignant Tumors
Overview
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).
Interventions
- Drug SSGJ-705
anti-PD-1 and anti-HER2 bispecific antibody
Primary outcome measures
- DLTs [Time frame: 14 days]
- AE [Time frame: up to 1 year]
- MTD or MAD [Time frame: up to 1 year]
- RP2D [Time frame: up to 1 year]
Secondary outcome measures (4)
- ORR [Time frame: up to 1 year]
- PFS [Time frame: up to 1 year]
- Cmax [Time frame: up to 1 year]
- T1/2 [Time frame: up to 1 year]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Affiliated Cancer Hospital of Shandong First Medical University — Jinan
Identifiers
NCT: NCT06390774 · SSGJ-705-CA-Ⅰ-01