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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

340 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-30

Study Completion Date

2027-12-12

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Locally Advanced, Recurrent or Metastatic Malignancies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1

advanced gastric cancer and breast cancer that have failed standard treatment

Group Type EXPERIMENTAL

SSGJ-705

Intervention Type DRUG

anti-PD-1 (programmed cell death protein 1) and anti-HER2 (Human Epidermal GrowthFactor Receptor 2)bispecifc antibody

Part 2

previously untreated advanced gastric cancer and lung cancer

Group Type EXPERIMENTAL

PD-1/L1 inhibitor combined with chemotherapy

Intervention Type DRUG

Immune checkpoint inhibitors

SSGJ-705 combined with chemotherapy

Intervention Type DRUG

anti-PD-1 and anti-HER2 bispecifc antibody

Interventions

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SSGJ-705

anti-PD-1 (programmed cell death protein 1) and anti-HER2 (Human Epidermal GrowthFactor Receptor 2)bispecifc antibody

Intervention Type DRUG

PD-1/L1 inhibitor combined with chemotherapy

Immune checkpoint inhibitors

Intervention Type DRUG

SSGJ-705 combined with chemotherapy

anti-PD-1 and anti-HER2 bispecifc antibody

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No