Clinical trial · Interventional
A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SSGJ-705 Monotherapy in Patients with Advanced Malignant Tumors
A Phase I Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SSGJ-705 Monotherapy in Patients with Advanced Malignant Tumors
NCT06390774CI-TRIAL-00081747recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced, Recurrent or Metastatic Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SSGJ-705 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Part 1
- description
- 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.
- interventionNames
- Drug: SSGJ-705
- type
- EXPERIMENTAL
- label
- Part 2
- description
- 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.
- interventionNames
- Drug: SSGJ-705
- type
- EXPERIMENTAL
- label
- Part 3
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.