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

Shenyang Sunshine Pharmaceutical

Status and phase: Begins enrollment this month; Phase 2

Conditions: Locally Advanced, Recurrent or Metastatic Malignancies

Treatments: Drug: SSGJ-705 combined with chemotherapy; Drug: PD-1/L1 inhibitor combined with chemotherapy; Drug: SSGJ-705

Study type: Interventional

Funder types: Industry

Identifiers

NCT07022002

SSGJ-705-201

Details and patient eligibility

About

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.

Full description

This study includes 2 Parts: Part 1 (705 monotherapy for advanced gastric cancer and breast cancer that have failed standard treatment), and Part 2 (705 in combination with chemotherapy for previously untreated advanced gastric cancer and lung cancer).

Enrollment: 340 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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340 participants in 2 patient groups

Part 1

Experimental group

Description:

advanced gastric cancer and breast cancer that have failed standard treatment

Treatment:

Drug: SSGJ-705

Part 2

Experimental group

Description:

previously untreated advanced gastric cancer and lung cancer

Treatment:

Drug: PD-1/L1 inhibitor combined with chemotherapy

Drug: SSGJ-705 combined with chemotherapy