A Phase I, Multi-Center, Open-Label, Dose Escalation Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of GQ1001, a HER2 Antibody-Drug Conjugate, in Patients with HER2-Positive Advanced Solid Tumors

Study Name
A Phase I, Multi-Center, Open-Label, Dose Escalation Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of GQ1001, a HER2 Antibody-Drug Conjugate, in Patients with HER2-Positive Advanced Solid Tumors
ClinicalTrials.gov Identifier (if applicable)
NCT04450732
Clinical Trial Category (check all that apply)
  • Targeted Therapy
Study Center
Institution Name
University of Texas MD Anderson Cancer Center
Institution Address
1840 Old Spanish Trail
City
Houston
State
Texas
Zip Code
77054
Country
United States
Study Contacts
Principal Investigator
Dr. Sarina Anne Piha-Paul
P.I. Phone
(713) 563-1055
P.I. Email
spihapau@mdanderson.org
Study Coordinator
William Ben Brugmann
Study Coordinator Phone
(713) 563-1930
Study Coordinator Email
WBrugmann@mdanderson.org
OVERVIEW – in layman’s terms (150 words max)
This is a Phase I dose finding study of GQ1001, an anti-HER2 antibody drug conjugate in adults with HER2-positive solid tumors. GQ1001 is administered once every 21-days. Routine safety lab tests and other necessary medical monitoring will be conducted by the site medical staff during the study.
Enrollment
26
Study Start Date
04/01/2020
Estimated Completion Date
12/31/2021
Inclusion Criteria – Patients Must:
  • .Signed informed consent form and able to comply with the protocol
  • Male or female 18 years of age and older
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening
  • Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiography (ECHO)
  • Patients must have pathologically documented advanced/unresectable or metastatic solid tumor with HER2 overexpression/expression that is refractory to standard therapy or for which there is no standard available therapy
  • Has adequate organ function within 7 days before the first treatment
  • Has adequate treatment washout period before the first treatment
  • Patients without a history of 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
Exclusion Criteria – Patients Must NOT:
  • 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 radiotherapy;
  • Any hematologic malignancies, including leukemia (any form), lymphoma, and multiple myeloma;
  • Cardiovascular dysfunction or clinically significant cardiac disease
  • Medical history of clinically significant lung disease or patients who are suspected to have these diseases by imaging at screening or requirement for supplemental oxygen
  • Known hypersensitivity to either the drug substances or inactive ingredients in the drug product
  • Grade ≥ 2 peripheral neuropathy
  • Unresolved toxicities from previous anticancer therapy
  • Cumulative anthracycline dose > 360 mg/m^2 doxorubicin or equivalent
  • Uncontrolled infection requiring i.v. of antibiotics, antivirals or antifungals
  • Active infection of hepatitis B or hepatitis C
  • 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
  • Women who are lactating or pregnant, as confirmed by pregnancy test within 7 days before first treatment
  • Male and female subjects who are unwilling to use adequate contraceptive methods during the study and for at least 7 months after the last dose of GQ1001