A First-In-Human, Dose Escalation and Expansion Study of GQ1007 Alone and in Combination with Envafolimab in Subjects with HER2-expressing Advanced Solid Tumors

Phase 1

Withdrawn

• Conditions: Solid Tumors; Cancer - Any cancer

• Registration Number: ACTRN12622000513718
• Lead Sponsor: GeneQuantum Healthcare (Suzhou) Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-31
• Last Update Posted: 3 October 2022

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 200

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,
-For hormonal therapy - more than or equal to 2 weeks,
-For chemotherapy or targeted therapy- more than or equal to 2 weeks (for 5-flourouracil based agents, folinate agents, and/or weekly paclitaxel, tyrosine kinase inhibitors); more than or equal to 4 weeks for HER2-directed biologic therapies; more than or equal to 6 weeks for nitrosoureas or mitomycin C; more than or equal to 3 weeks for any other chemotherapy/targeted therapy.
Additional inclusion criteria for Part 1 and Part 3
9. Has the protocol specified malignancies such as breast cancer, gastric cancer, gastroesophageal junction cancer, urothelial cancer, salivary gland carcinoma, gallbladder carcinoma, cholangiocarcinoma, or non-small cell lung cancer.
Additional inclusion criteria for Part 2 and Part 4
10. Agrees to provide a HER2 test report from tumor biopsy performed within the past 6 months or an archived tumor sample collected within the past 6 months, and if neither is available, a fresh tumor biopsy to confirm HER2 status if any studied tumor is accessible.
Additional inclusion criteria for Part 2a
11. Has breast cancer with HER2 overexpression (immunohistochemistry [IHC] 3+ or [IHC 2+ and in situ hybridization]).
Additional inclusion criteria for Part 2b
12. Has breast cancer with HER2 low expression (immunohistochemistry [IHC] 2+ or ISH or IHC 1+). Subjects with HER2 low expression metastatic breast cancer who have exhausted treatments that can confer any clinically meaningful benefit are also eligible.
Additional inclusion criteria for Part 2c
13. Subject has either a solid malignant tumor with HER2 expression or HER2 mutatio

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.
11. Cumulative anthracycline dose greater than 360 mg/m2 doxorubicin or equivalent.
12. Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
13. Known human immunodeficiency virus (HIV) infection.
14. Active infection with hepatitis C or hepatitis B except that subjects with occult or prior hepatitis B infection may be included if Hepatitis B Virus's Deoxyribonucleic acid (DNA) is undetectable at the time of screening, and these subjects must be willing to monthly DNA testing and appropriate antiviral therapy as indicated.
15. A positive test result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by a certified nucleic acid test within the last 30 days before the first dose of study treatment.
16. Receipt of a live vaccine within 30 days prior to the first dose of study treatment.
17. Pregnant or lactating women
18. Unwilling to use adequate contraceptive methods during the study and for at least 7 months after the last dose of study tratments.
Additional exclusion criteria for Part 2 and Part 4
19. Subjects with multiple primary malignancies within 2 years, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease, other solid tumors curatively treated, or contralateral breast cancer.

Study & Design

• Study Type: Interventional
• Study Design: Not specified