Clinical trial · Interventional
SSGJ-705 Monotherapy and Combination Therapy in Advanced HER2-Expressing Solid Tumors
A Phase II Study to Evaluate the Safety and Efficacy of SSGJ-705 Monotherapy and Combination Therapy in Patients With Advanced HER2-Expressing Solid Tumors
NCT07022002CI-TRIAL-00093014recruitingPhase 2ClinicalTrials.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 Ⅱ study to evaluate the safety and efficacy of SSGJ-705 Monotherapy and Combination Therapy in patients with advanced HER2-Expressing Solid Tumors.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PD-1/L1 inhibitor combined with chemotherapy | Drug | — | UNRESOLVED |
| SSGJ-705 | Drug | — | UNRESOLVED |
| SSGJ-705 combined with chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part 1
- description
- advanced gastric cancer and breast cancer that have failed standard treatment
- interventionNames
- Drug: SSGJ-705
- type
- EXPERIMENTAL
- label
- Part 2
- description
- previously untreated advanced gastric cancer and lung cancer
- interventionNames
- Drug: PD-1/L1 inhibitor combined with chemotherapy
- Drug: SSGJ-705 combined with chemotherapy
Primary outcomes (3)
- measure
- Objective response rate (ORR)
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Males and/or females over age 18. * Histologically and/or cytologically documented local advanced or metastatic non-Small Cell Lung Cancer（NSCLC），Breast Cancer（BC）or Gastric/Gastroesophageal Junction Cancer （G/GEJC). * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * Expected survival \>3 months. * Signed informed consent form. Exclusion Criteria: * Any remaining adverse events (AEs) \> grade 1 from prior anti-tumor treatment as per Common Terminology Criteria for Adverse Events（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. * Inadequate organ or bone marrow function.
References
Publications (0)
Data not yet available
No reference posted for this study.