RECRUITING

Safety of GQ1001 in Adult Patients With HER2-Positive Advanced Solid Tumors

Conditions

HER2-positive Breast Cancer HER2-positive Biliary Tract Cancer HER2-Positive Salivary Gland Carcinomas HER2-Positive Advanced Solid Tumor HER2-positive Biliary Tract Cancer Salivary Gland Carcinomas Non- Small Cell Lung Cancer Advanced Solid Tumor

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Phase I Dose Finding Study for GQ1001 in Patients with HER2-Positive Advanced Solid Tumors

Official Title

A Phase 1, First-In-Human, Multicenter, Open-Label, Study of GQ1001, a HER2 Targeted Antibody-Drug Conjugate, Administered Intravenously, in Adult Patients With HER2-Positive Advanced Solid Tumors

Quick Facts

Study Start:2020-07-07

Study Completion:2024-05-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04450732

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Signed informed consent form and able to comply with the protocol; 2. Male and female subjects ≥18 years of age; 3. ECOG PS of 0 or 1, the estimated life expectancy ≥ 3 months; 4. LVEF ≥ 50% as determined by echocardiography (ECHO); 5. Patients must have pathologically documented advanced/unresectable or metastatic solid tumor with HER2-positive (as defined below) that is relapsed or refractory to standard therapy or for which there is no standard therapy and progressed. Patients must have a least one measurable disease lesion. Tumor specimens to identify HER2 status should be obtained within the past 6 months. * Advanced/unresectable or metastatic breast cancer: immunohistochemistry (IHC) 3+, or IHC 2+ and in situ hybridization positive (ISH+)\; Advanced/unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma: IHC 3+, or IHC 2+ and ISH+\; Other HER2-positive advanced/unresectable or metastatic solid malignant tumor: determined by IHC, ISH, Next Generation Sequencing, or other analysis techniques as appropriate; * ISH: fluorescence in situ hybridization (FISH) or dual in situ hybridization (DISH); ISH positivity is defined as a ratio of ≥ 2.0 for the number of HER2 gene copies to the number of signals for CEP17. ISH assay is not required when IHC result is 3+. ISH assay should be performed to confirm HER2 positivity when IHC result is 2+. 6. Adequate organ function confirmed at screening and within 7 days before the first treatment, as evidenced by: 7. Adequate washout period before the first treatment as defined by: 8. Patients without a history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections or with a history of AIDS-defining opportunistic infections and have not had an opportunistic infection within the past 12 months may be enrolled per the discretion of the Investigator.	1. Clinically active brain metastases, defined as untreated and symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms. Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with steroids may be included in the study if they have recovered from the acute toxic effect of chemotherapy or radiotherapy; 2. 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); 3. Cardiovascular dysfunction or clinically significant cardiac disease, including but not limited to: * Medical history of symptomatic chronic heart failure (New York Heart Association (NYHA) classes II-IV) or serious cardiac arrhythmia requiring treatment; * Medical history of myocardial infarction or unstable angina within 6 months of the first treatment; * Corrected QT interval by Fridericia (QTcF) prolongation of \> 450 milliseconds (ms) in males and \> 470 ms in females; 4. Medical history of clinically significant lung disease (e.g., interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis), or patients who are suspected to have these diseases by imaging at screening or requirement for supplemental oxygen; 5. Known hypersensitivity to either the drug substances or inactive ingredients in the drug product; 6. Existing Grade ≥ 2 peripheral neuropathy; 7. Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI CTCAE version 5.0, Grade ≤ 1 or baseline. Subjects with chronic Grade 2 toxicities may be eligible per the discretion of the Investigator; 8. Cumulative anthracycline dose \> 360 mg/m2 doxorubicin or equivalent; 9. Uncontrolled infection requiring i.v. of antibiotics, antivirals or antifungals; 10. Active infection with hepatitis C (e.g., detectable antibodies to hepatitis C virus \[HCV\]) or hepatitis B (e.g., hepatitis B surface antigen \[HBsAg\] positive) except subjects with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HBsAg) may be included if hepatitis B virus (HBV) deoxyribonucleic acid (DNA) is undetectable at the time of screening, and these subjects must be willing to undergo monthly DNA testing and appropriate antiviral therapy as indicated; 11. Patients with a history or current evidence of any concomitant condition, therapy, or laboratory abnormality that, in the opinion of the Investigator, might confound the results of the trial, interfere with the patient's participation and compliance; 12. Women who are lactating or pregnant, as confirmed by pregnancy test within 7 days before first treatment; 13. Male and female subjects who are unwilling to use adequate contraceptive methods (e.g., concomitant use of a spermicidal agent, barrier contraceptive, or/and intrauterine contraceptive) during the study and for at least 7 months after the last dose of GQ1001.

Inclusion Criteria

Exclusion Criteria

1. Signed informed consent form and able to comply with the protocol;
2. Male and female subjects ≥18 years of age;
3. ECOG PS of 0 or 1, the estimated life expectancy ≥ 3 months;
4. LVEF ≥ 50% as determined by echocardiography (ECHO);
5. Patients must have pathologically documented advanced/unresectable or metastatic solid tumor with HER2-positive (as defined below) that is relapsed or refractory to standard therapy or for which there is no standard therapy and progressed. Patients must have a least one measurable disease lesion. Tumor specimens to identify HER2 status should be obtained within the past 6 months.
* Advanced/unresectable or metastatic breast cancer: immunohistochemistry (IHC) 3+, or IHC 2+ and in situ hybridization positive (ISH+)\*;
* Advanced/unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma: IHC 3+, or IHC 2+ and ISH+\*;
* Other HER2-positive advanced/unresectable or metastatic solid malignant tumor: determined by IHC, ISH, Next Generation Sequencing, or other analysis techniques as appropriate;
* ISH: fluorescence in situ hybridization (FISH) or dual in situ hybridization (DISH); ISH positivity is defined as a ratio of ≥ 2.0 for the number of HER2 gene copies to the number of signals for CEP17. ISH assay is not required when IHC result is 3+. ISH assay should be performed to confirm HER2 positivity when IHC result is 2+.
6. Adequate organ function confirmed at screening and within 7 days before the first treatment, as evidenced by:
7. Adequate washout period before the first treatment as defined by:
8. Patients without a history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections or with a history of AIDS-defining opportunistic infections and have not had an opportunistic infection within the past 12 months may be enrolled per the discretion of the Investigator.

1. Clinically active brain metastases, defined as untreated and symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms. Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with steroids may be included in the study if they have recovered from the acute toxic effect of chemotherapy or radiotherapy;
2. 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);
3. Cardiovascular dysfunction or clinically significant cardiac disease, including but not limited to:
* Medical history of symptomatic chronic heart failure (New York Heart Association (NYHA) classes II-IV) or serious cardiac arrhythmia requiring treatment;
* Medical history of myocardial infarction or unstable angina within 6 months of the first treatment;
* Corrected QT interval by Fridericia (QTcF) prolongation of \> 450 milliseconds (ms) in males and \> 470 ms in females;
4. Medical history of clinically significant lung disease (e.g., interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis), or patients who are suspected to have these diseases by imaging at screening or requirement for supplemental oxygen;
5. Known hypersensitivity to either the drug substances or inactive ingredients in the drug product;
6. Existing Grade ≥ 2 peripheral neuropathy;
7. Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI CTCAE version 5.0, Grade ≤ 1 or baseline. Subjects with chronic Grade 2 toxicities may be eligible per the discretion of the Investigator;
8. Cumulative anthracycline dose \> 360 mg/m2 doxorubicin or equivalent;
9. Uncontrolled infection requiring i.v. of antibiotics, antivirals or antifungals;
10. Active infection with hepatitis C (e.g., detectable antibodies to hepatitis C virus \[HCV\]) or hepatitis B (e.g., hepatitis B surface antigen \[HBsAg\] positive) except subjects with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HBsAg) may be included if hepatitis B virus (HBV) deoxyribonucleic acid (DNA) is undetectable at the time of screening, and these subjects must be willing to undergo monthly DNA testing and appropriate antiviral therapy as indicated;
11. Patients with a history or current evidence of any concomitant condition, therapy, or laboratory abnormality that, in the opinion of the Investigator, might confound the results of the trial, interfere with the patient's participation and compliance;
12. Women who are lactating or pregnant, as confirmed by pregnancy test within 7 days before first treatment;
13. Male and female subjects who are unwilling to use adequate contraceptive methods (e.g., concomitant use of a spermicidal agent, barrier contraceptive, or/and intrauterine contraceptive) during the study and for at least 7 months after the last dose of GQ1001.

Contacts and Locations

Study Contact

Yan Shi

CONTACT

0512-66526166

shiy@genequantum.com

Study Locations (Sites)

M.D. Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: GeneQuantum Healthcare (Suzhou) Co., Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-07-07

Study Completion Date2024-05-01

Study Record Updates

Study Start Date2020-07-07

Study Completion Date2024-05-01

Terms related to this study

Keywords Provided by Researchers

HER2-positive
Biliary Tract Cancer
Salivary Gland Carcinomas
Non- Small Cell Lung Cancer
Advanced Solid Tumor

Additional Relevant MeSH Terms

HER2-positive Breast Cancer
HER2-positive Biliary Tract Cancer
HER2-Positive Salivary Gland Carcinomas
HER2-Positive Advanced Solid Tumor