SSGJ-705 Monotherapy and Combination Therapy in Advanced HER2-Expressing Solid Tumors

NCT07022002
clinicaltrials.gov
Phase
Phase 2
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Participants
340
clinicaltrials.gov
Lead sponsor
Shenyang Sunshine Pharmaceutical Co., LTD.
clinicaltrials.gov
Start date
2025-07-30
clinicaltrials.gov
Number of sites
1
clinicaltrials.gov

Summary
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.
clinicaltrials.gov
Short title
SSGJ-705 Monotherapy and Combination Therapy in Advanced HER2-Expressing Solid Tumors
clinicaltrials.gov
Official title
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
clinicaltrials.gov

Control arm
Open label
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Phase
Phase 2
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2027-12-12
clinicaltrials.gov
First posted
2025-06-15
clinicaltrials.gov
Registry last updated
2025-08-03
clinicaltrials.gov
Primary completion date
2026-12-31
clinicaltrials.gov
Start date
2025-07-30
clinicaltrials.gov

Participants
340
clinicaltrials.gov
Participant count basis
Estimated
clinicaltrials.gov
Planned participants
340
clinicaltrials.gov
Protocol amendments
1
clinicaltrials.gov
Number of sites
1
clinicaltrials.gov

Data monitoring committee
No
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
Shenyang Sunshine Pharmaceutical Co., LTD.
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT07022002
clinicaltrials.gov
ClinicalTrials.gov ID
NCT07022002
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Not applicable
Model
Single group
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Objective response rate (ORR)

    Timeframe: 12 months

    The primary efficacy end point

  2. Incidence of Treatment-Emergent Adverse Events

    Timeframe: 12 months

    The primary safety end point

  3. Severity of Treatment-Emergent Adverse Events

    Timeframe: 12 months

    The primary safety end point

  1. Progression-Free-Survival (PFS)

    Timeframe: 24 months

    The secondary efficacy end point

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No

  • 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.

  • 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.
Sources for eligibility
clinicaltrials.gov

  • Zhejiang Cancer HospitalHangzhou, ChinaRecruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)