SSGJ-709 for people with advanced malignant tumors

A Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Anti-tumor Activity of SSGJ-709 in Patients With Advanced Malignant Tumors

This clinical trial will try SSGJ-709, an experimental intravenous drug given every three weeks, in people with advanced malignant tumors who have exhausted or cannot receive standard treatments to see if it is safe and shows anti-tumor activity.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Adelaide)
• Trial ID: NCT07016490 on ClinicalTrials.gov

What this trial studies

This open-label Phase 1 study uses a dose-escalation phase to find a safe dose of SSGJ-709 and a dose-expansion phase to further study that dose in a larger group. Participants receive SSGJ-709 infusions once every three weeks and return for clinic assessments and safety monitoring on the same schedule. Primary goals are to characterize safety, tolerability, and pharmacokinetics, with secondary measures of anti-tumor activity by RECIST v1.1. Eligible patients have histologically confirmed locally advanced or metastatic malignant tumors, ECOG performance status 0–1, measurable disease, and have failed or are intolerant of standard therapies.

Who should consider this trial

Good fit: Adults with confirmed locally advanced or metastatic malignant tumors, ECOG 0–1, life expectancy of at least three months, measurable disease per RECIST v1.1, and prior failure or intolerance of standard treatments are the intended participants.

Not a fit: Patients who still have effective standard-of-care treatment options, have poor performance status (ECOG >1), a life expectancy under three months, or cannot attend the Adelaide site are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, SSGJ-709 could become a new treatment option that helps control tumor growth for some patients with advanced malignancies.

How similar studies have performed: Early-phase trials of other novel oncology agents have sometimes shown promising safety or activity but many do not demonstrate clear clinical benefit, so this approach remains experimental and not yet proven.

Eligibility criteria

Inclusion Criteria:

* Minimum life expectancy of 3 months;
* Eastern Cooperative Oncology Group (ECOG) Performance status (PS) score of 0-1;
* Locally advanced or metastatic malignant tumors confirmed by histopathology or cytology; preferred tumor types for enrollment include head and neck squamous cell carcinoma, non-small cell lung cancer, esophageal squamous cell carcinoma or adenocarcinoma, gastric or gastroesophageal junction adenocarcinoma, colorectal adenocarcinoma, hepatocellular carcinoma, urothelial carcinoma, and clear cell renal cell carcinoma. Subjects with other tumor types may be enrolled after discussion with the sponsor；
* Subject who have failed, or has been intolerant to standard therapy, or has been considered lack standard of care for a given tumor type, and who is not able to complete surgical resection and receive curative concurrent/sequential chemoradiotherapy；
* Having at least one measurable tumor lesion as the target lesion assessed per RECIST v1.1；
* The subject has adequate hematological and organ functions；

Exclusion Criteria:

* Presence of brainstem, meningeal metastases, spinal cord metastases or compression；
* Presence of active central nervous system (CNS) metastases；
* Subjects with pleural effusion, pericardial effusion, or ascites that are clinically symptomatic or require repeated drainage；
* Subjects with other malignant tumors within 3 years prior to screening；
* Subjects with autoimmune diseases that require systemic treatment within 2 years before screening；
* Subjects are positive for human immunodeficiency virus (HIV)；
* Prior or current presence of non-infectious pneumonia/interstitial lung disease requiring systemic therapy with glucocorticoids；
* Serious infection within 4 weeks prior to the first dose or the presence of any active infection requiring systemic anti-infective therapy.
* Having received the following treatments prior to the first dose of study treatment:

  1. Having received anti-tumor therapies such as biological agents, chemotherapy and other investigational drugs not approved for marketing within 3 weeks prior to the first dose of study treatment (Patient may be enrolled if the first dose of study treatment is more than 5 half-lives of the drug from the last anti-tumor therapy);
  2. Having received small molecule targeted antineoplastic agents (e.g., tyrosine kinase inhibitor), or palliative local therapy for non-target lesions, or non-specific immunomodulatory therapy (e.g., interleukin, interferon, thymosin, tumor necrosis factor) within 2 weeks prior to the first dose;
  3. Having received herbal medicine with an anti-tumor indication within 1 week prior to the first dose;
  4. Prior immunotherapy other than anti-PD-(L)1 therapy (Patients with prior immunotherapy against other targets may be enrolled after discussion and agreement with the sponsor).

Where this trial is running

Adelaide

• Southern Oncology Clinical Research Unit (SOCRU) — Adelaide, Australia (Recruiting)

Study contacts

• Principal investigator: Andrew Parsonson — Macquarie University
• Study coordinator: Andrew Parsonson

Conditions Advanced Malignant Tumors