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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04450732




Registration number
NCT04450732
Ethics application status
Date submitted
23/06/2020
Date registered
29/06/2020
Date last updated
19/01/2021

Titles & IDs
Public title
Safety of GQ1001 in Adult Patients With HER2-Positive Advanced Solid Tumors
Scientific 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
Secondary ID [1] 0 0
GQ1001X2101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HER2-positive Breast Cancer 0 0
HER2-positive Gastric Cancer 0 0
Advanced Solid Tumor 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GQ1001

Experimental: GQ1001 1.2 mg/kg - Administered intravenously every 21 days.

Experimental: GQ1001 2.4 mg/kg - Administered intravenously every 21 days.

Experimental: GQ1001 3.6 mg/kg - Administered intravenously every 21 days.

Experimental: GQ1001 4.8 mg/kg - Administered intravenously every 21 days.

Experimental: GQ1001 6.0 mg/kg - Administered intravenously every 21 days.


Treatment: Drugs: GQ1001
anti-HER2 antibody drug conjugate

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maximum Tolerated Dose (MTD) and/or Dose Limiting Toxicities (DLTs). - Adverse events will be assessed using NCI CTCAE version 5.0 and will be evaluated by the investigator and the sponsor for the eligibility of DLT.
Timepoint [1] 0 0
End of Cycle 1 (21-day cycle)
Secondary outcome [1] 0 0
Incidence and Severity of Adverse Events (AEs) - Safety and Tolerability of GQ1001
Timepoint [1] 0 0
Cycle 1 through Cycle 8 (each cycle is 21 days) and up to 30 days from treatment discontinuation
Secondary outcome [2] 0 0
Number of Participants with Abnormal Laboratory Values - Safety and Tolerability of GQ1001
Timepoint [2] 0 0
Cycle 1 through Cycle 8 (each cycle is 21 days) and up to 30 days from treatment discontinuation
Secondary outcome [3] 0 0
Area Under the Plasma Concentration Versus Time Curve (AUC) of GQ1001
Timepoint [3] 0 0
Cycle 1 through Cycle 8 (each cycle is 21 days)
Secondary outcome [4] 0 0
Peak Plasma Concentration of GQ1001 (Cmax)
Timepoint [4] 0 0
Cycle 1 through Cycle 8 (each cycle is 21 days)
Secondary outcome [5] 0 0
Time at which the Cmax is Observed (Tmax)
Timepoint [5] 0 0
Cycle 1 through Cycle 8 (each cycle is 21 days)
Secondary outcome [6] 0 0
Half Life of GQ1001 (T1/2)
Timepoint [6] 0 0
Cycle 1 through Cycle 8 (each cycle is 21 days)
Secondary outcome [7] 0 0
Mean Residence Time of GQ1001 (MRT)
Timepoint [7] 0 0
Cycle 1 through Cycle 8 (each cycle is 21 days)
Secondary outcome [8] 0 0
Volume of Distribution of GQ1001 (Vd)
Timepoint [8] 0 0
Cycle 1 through Cycle 8 (each cycle is 21 days)
Secondary outcome [9] 0 0
Preliminary Efficacy of GQ1001 Evaluated using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and CT of MRI scans
Timepoint [9] 0 0
through study completion, an average 24 weeks

Eligibility
Key inclusion criteria
1. Signed informed consent form and able to comply with the protocol;

2. Male or female 18 years of age and older;

3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening;

4. Left ventricular ejection fraction (LVEF) = 50% by echocardiography (ECHO);

5. 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;

6. Has adequate organ function within 7 days before the first treatment;

7. Has adequate treatment washout period before the first treatment;:

8. 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 radiotherapy;

2. Any hematologic malignancies, including leukemia (any form), lymphoma, and multiple
myeloma;

3. Cardiovascular dysfunction or clinically significant cardiac disease;

4. 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;

5. Known hypersensitivity to either the drug substances or inactive ingredients in the
drug product;

6. Grade = 2 peripheral neuropathy;

7. Unresolved toxicities from previous anticancer therapy;

8. Cumulative anthracycline dose > 360 mg/m^2 doxorubicin or equivalent;

9. Uncontrolled infection requiring i.v. of antibiotics, antivirals or antifungals;

10. Active infection of hepatitis B or hepatitis C;

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
during the study and for at least 7 months after the last dose of GQ1001;

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Scientia Clinical Research Limited - Randwick
Recruitment hospital [2] 0 0
Cabrini Institute in Melbourne, Australia - Melbourne
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
3050 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GeneQuantum Healthcare (Suzhou) Co., Ltd.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
CRC Oncology
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Phase I Dose Finding Study for GQ1001 in Patients with HER2-Positive Advanced Solid Tumors
Trial website
https://clinicaltrials.gov/show/NCT04450732
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sarina Piha-Paul
Address 0 0
M.D. Anderson Cancer Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ke Chen
Address 0 0
Country 0 0
Phone 0 0
+8613306139991
Fax 0 0
Email 0 0
chenk@genequantum.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04450732