ACTRN12622000513718
Withdrawn
Phase 1
A Phase I, First-In-Human, Multicenter, Open-Label, Dose Escalation and Expansion Study of GQ1007 Alone and in Combination with Envafolimab in Subjects with HER2-expressing Advanced Solid Tumors
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Solid Tumors
- Sponsor
- GeneQuantum Healthcare (Suzhou) Co., Ltd.
- Enrollment
- 200
- Status
- Withdrawn
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male and female subjects more than or equal to 18 years of age with a life expectancy of more than 3 months.
- •2\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\.
- •3\. Left ventricular ejection fraction (LVEF) more than or equal to 50% by either echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days before the first dose of study treatment.
- •4\. Agrees to submit fresh tumor biopsy samples for biomarkers if any studied tumor is accessible.
- •5\. Histologically or cytologically confirmed malignancy diagnosis and at least 1 measurable pathologically documented advanced/unresectable or metastatic solid tumor as assessed by RECIST 1\.1\.
- •6\. Documented progressive disease, refractory to/intolerant of standard therapy, or there is no standard therapy.
- •7\. Adequate organ function confirmed at screening and within 7 days before the first dose of study treatment as evidenced by platelet count (more than or equal to 100,000/mm3\), hemoglobin (more than or equal to 8g/dl), Absolute neutrophil count (more than or equal to 1500/mm3\), Serum creatinine (less than or equal to 1\.5 × upper limit of normal\[ULN], or estimated creatinine clearance more than or equal to 60 mL/min (Cockcroft\-Gault formula), alanine transaminase and aspartate transaminase less than or equal to 2\.5 × ULN (less than or equal to 5 × ULN if liver metastases are present), total bilirubin (less than or equal to 1\.5 × ULN or less than or equal to 2 × ULN for subjects with Gilbert’s Syndrome), Prothrombin time and activated partial thromboplastin time (less than or equal to 1\.5 × ULN).
- •8\. Adequate washout period before the first treatment
- •\-For any major surgery, radiation therapy, immunotherapy, and any investigational agents or treatments\- more than or equal to 4 weeks,
- •\-For autologous transplants \- more than or equal to 3 months,
Exclusion Criteria
- •1\. Clinically active brain metastases, defined as untreated and symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms.
- •2\. Conditions requiring systemic treatment with either corticosteroids (more than 10 mg daily prednisone equivalent) within 7 days or taking any other immunosuppressive medication within 14 days prior to the first dose of study treatment.
- •3\. Active autoimmune disease that required systemic treatment (disease modifying agents, corticosteroids, or immunosuppressive drugs) within the past 2 years.
- •4\. Prior organ or tissue allograft.
- •5\. History of Grade 3 or higher toxicity related to prior T cell agonist or checkpoint inhibitor.
- •6\. Poorly controlled diarrhea (e.g., watery stool, uncontrolled bowel movement with drugs, Grade more than or equal to 2 ).
- •7\. Cardiovascular dysfunction or clinically significant cardiac disease.
- •8\. Medical history of clinically significant lung disease.
- •9\. Known hypersensitivity to either the drug substances or inactive ingredients in the drug product.
- •10\. Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade 1 or less or baseline.
Outcomes
Primary Outcomes
Not specified
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