HER2 Expressing or Mutated Advanced Malignant Solid TumorsPhase 1NCT06154343
A Study of GQ1005 in Subjects With HER2-Expressing Advanced Solid Tumors
A Phase 1 study testing GQ1005 in people with HER2 Expressing or Mutated Advanced Malignant Solid Tumors, run by GeneQuantum Healthcare (Suzhou) Co., Ltd. at 20 sites in China.
Trial summary
This is an open-label, phase I study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of GQ1005 and preliminary anti-tumor efficacy in HER2 expressing or mutated advanced malignant solid tumor subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2 Expressing or Mutated Advanced Malignant Solid Tumors
- What is being tested?
- GQ1005
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 20 sitesChina
- Study dates
- 23 Nov 2022to 30 Jul 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The general inclusion criteria for dose escalation in Part 1 and dose expansion in Part 2 are as follows:
- Voluntary agreement to provide written informed consent；
- Aged 18 years or older, both male and female.
- The expected survival time is more than 3 months.
- ECOG performance status Score 0 or 1.
- LVEF ≥ 50% by ECHO or MUGA scan within 28 days prior to the first dose of study drug.
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- Histologically or cytologically confirmed malignancy with at least 1 measurable lesion as assessed by RECIST v1.1.
- Good organ function, confirmed by the following laboratory test results at Screening and within 7 days prior to the first dose of study drug:
- Platelet count ≥ 100,000/mm3; hemoglobin ≥ 9g/dL; ANC ≥ 1500/mm3; Serum CREA ≤ 1.5 × ULN, or estimated CREA clearance ≥ 60 mL/min (Cockcroft-Gault equation); ALT and AST ≤ 3 × ULN (≤ 5 x ULN if liver metastases are present); Total bilirubin ≤ 1.5 x ULN for subjects with Gilbert's syndrome or ≤ 2 x ULN for subjects with liver metastases at baseline; Prothrombin time and activated partial thromboplastin time ≤ 1.5 × ULN;
- Adequate washout period prior to the first treatment, defined as follows:
- Major surgery ≥ 4 weeks; radiotherapy ≥ 4 weeks (≥ 2 weeks if the radiotherapy is palliative stereotactic radiotherapy without abdominal involvement); seed-radioactive therapy ≥ 3 months; Nuclein therapy ≥ 3 months; autotransplantation ≥ 3 months; Hormone therapy ≥ 2 weeks or as per investigator's judgment (breast cancer subjects) Chemotherapy or targeted therapy (including antibody drug therapy) ≥ 2 weeks (5-FU-based drugs, folinic acid preparations and/or weekly paclitaxel therapy);
- 2 weeks (or 5 half-lives, whichever is longer) (tyrosine kinase inhibitor);
- 4 weeks (HER2-targeted biological therapy);
- 6 weeks (nitrosourea or mitomycin C);
- 3 weeks (any other chemotherapy/targeted therapy);
- 2 weeks (Chinese patent medicine with clear antitumor indication) antitumor immunotherapy ≥ 4 weeks; Any investigational drug or treatment ≥ 4 weeks; Strong inhibitors of cytochrome P450 enzyme 3A4 (CYP3A4) ≥ 1 week; Organic Anion Transport Polypeptide (OATP) Inhibitors ≥ 1 week;
- Inclusion criteria for the dose escalation phase of Part 1 only:
- Failure of standard treatment, or intolerance, or absence of standard treatment, confirmed by pathology, HER2 expression (including IHC1+, IHC2+, IHC3+ and/or ISH*+) or subjects with advanced/unresectable or metastatic solid tumors with HER2 exon 19 or 20 mutations (non-small cell lung cancer only). If only ISH*, NGS reports are available, contact the Medical Monitor.
- Failure of standard treatment, intolerance, or absence of standard treatment, confirmed by pathology, HER2 overexpression (IHC 3+ or IHC 2+ and ISH* +) Advanced/unresectable or metastatic breast cancer.
- Advanced breast cancer with low HER2 expression, unresectable, or metastatic breast cancer that has failed standard treatment, or is not tolerated, or has no standard treatment, is confirmed by pathology. (IHC 2+ and ISH*- or ISH unknown, or IHC 1+).
- Non-small cell lung cancer with a HER2 exon 19 or 20 mutation that has failed, or is not tolerated, or is confirmed by a documented pathology without standard treatment.
- Advanced/unresectable or metastatic solid tumors with HER2 expression that have failed standard therapy, are not tolerated, or are without standard therapy, and are confirmed by pathology, with HER2 overexpression preferred. (IHC 3+ or IHC 2+ or ISH* +) Adenocarcinoma of gastric and gastroesophageal junction; Other preferred tumor types include HER2 overexpression. (IHC 3+ or IHC 2+ or ISH* +) Urothelial cancer, biliary tract cancer, endometrial cancer; Breast cancer and non-small cell lung cancer are excluded.
- ISH+: FISH or two-color in situ hybridization (DISH).
Who cannot join
- Subjects must not meet any of the following exclusion criteria to be enrolled in the study.
- Clinically active brain metastases, defined as untreated and symptomatic, or requiring treatment with steroids or anticonvulsants to control associated symptoms. Subjects with treated asymptomatic brain metastases who do not require steroid therapy may be included in the study if they have recovered from the acute toxicity of radiation therapy.
- Cardiovascular dysfunction or clinically significant cardiac conditions, including but not limited to:
- Symptomatic CHF (New York Heart Association classes II to IV) or severe cardiac arrhythmia requiring treatment
- History of myocardial infarction or troponin levels consistent with myocardial infarction (defined by the American College of Cardiology guidelines) within 6 months prior to the first dose, and unstable angina pectoris within 6 months prior to the first dose of study drug;
- QTcF prolongation at Screening >460 milliseconds (ms) (male) and >470 ms (female) except for right bundle branch block.
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- Clinically significant acute and chronic lung disease. (e.g., interstitial pneumonia, pulmonary infection, pulmonary fibrosis, and severe radiation pneumonitis), or subjects with suspected pulmonary disease based on imaging at screening, or subjects requiring oxygen.
- People with known hypersensitivity to recombinant humanized anti-HER2 monoclonal antibody-DXd conjugate drugs and their components or to humanized monoclonal antibody products.
- Poorly controlled pleural, ascites, or pericardial effusions.
- Toxicity that has not resolved from prior antineoplastic therapy, defined as toxicity (other than alopecia) that has not resolved to ≤ Grade 1 or baseline levels, is at the discretion of the investigator for the eligibility of subjects with chronic Grade 2 toxicities.
- The prior anthracycline exposure dose met the following criteria: adriamycin > 500mg/m2; Epirubicin >900mg/m2; Pirarubicin > 950mg/m2; Mitoxanthraquinone >120mg/m2; other (i.e. liposomal doxorubicin or other anthracycline >equivalent to 500 mg/m2 of doxorubicin); If more than one anthracycline is used, the cumulative dose must not exceed the equivalent of 500 mg/m2 of doxorubicin.
- There is an active infection requiring treatment with intravenous antibiotics, antivirals, or antifungals.
- Known HIV infection.
- Active hepatitis C virus infection. (HCV antibody positive and HCV-RNA higher than the upper limit of reference value); Active hepatitis B virus infection. (HBsAg positive and/or HBcAb positive and HBV-DNA quantitation ≥2000 IU/ml);, to be eligible for enrollment, subjects with chronic hepatitis B will have to agree to monthly DNA testing and receive appropriate antiviral therapy as indicated.
- Live vaccine was administered within 30 days prior to the first dose of study drug.
- Previous or current evidence of any concomitant disease, treatment, or laboratory abnormality that the investigator believes may confound the results of the trial or interfere with subject participation and compliance.
- He has received treatment with an antibody-conjugated drug comprising a topoisomerase I inhibitor ezotecan derivative.
- Breastfeeding women or women with confirmed pregnancy by a pregnancy test within 7 days prior to the first treatment.
- Reluctant to contraception during the study and for at least 7 months after the last dose of study drug.
- Subjects with multiple primary malignancies within the past 3 years, with the exception of fully resected non-melanoma skin cancer, cured disease in situ, cured contralateral breast cancer.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
China20 sites, 20 recruiting
- Recruiting
Chinese PLA general hospital
Beijing, Beijing Municipality, 100039
Bo Yang, MD. Ph.D
- Recruiting
Sichuan Cancer Hospital
Chengdu, Sichuang, 610042
Jin Lu, MD.Ph.D
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400042
The FAHOZ University
Qiao Cheng, MD.Ph.D
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Wu Zhuang, MD. Ph.D
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Rongbo Lin, MD.Ph.D
- Recruiting
The First Affiliated Hospital of Haerbin Medical University
Haerbin, Heilongjiang, 150007
Zhiwei Li, MD.Ph.D
- Recruiting
Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310020
Xian Wang, MD. Ph.D
- Recruiting
Shandong Cancer Hospital
Jinan, Shandong, 250117
Linlin Wang, MD.Ph.D
Yuping Sun, MD.Ph.D
- Recruiting
Linyi Cancer Hospital
Linyi, Shandong, 276002
Jingfen Wang, MD. Ph.D
- Recruiting
Affiliated Drum Tower Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, 210008
Jia Wei, MD. Ph.D
- Recruiting
Fudan university Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Biyun wang, MD. Ph.D
Jian zhang, MD. Ph.D
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality
Caicun Zhou, MD. Ph.D
- Recruiting
Shengjing hospital of China medical universty
Shenyang, Liaoning, 110136
Caigang Liu, MD. Ph.D
- Recruiting
Suining Central Hospital
Suining, Sichuan, 629099
Hongwei Yang, MD. Ph.D
- Recruiting
Tianjin medical university cancer institute & hospital
Tianjin, Tianjin Municipality, 300181
Ting Deng, MD. Ph.D
- Recruiting
The First Affiliated Hospital of Xi'an University
Xi'an, Shangxi, 710061
Enxiao Li, MD.Ph.D
- Recruiting
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, 453199
Yinghua Ji, MD.Ph.D
- Recruiting
Yantai Yuhuangding Hospital
Yantai, Shandong, 264099
Jian Chen, MD.Ph.D
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450003
Qiming Wang, MD. Ph.D
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Xingya Li, MD. Ph.D
About this study
Official title: A Phase 1, First-In-Human, Multicenter, Open-Label,Dose-Escalation and Extension Study of GQ1005 in Subjects With HER2-Expressing Advanced Solid Tumors
This is an open-label, phase I study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of GQ1005 and preliminary anti-tumor efficacy in HER2 expressing or mutated advanced malignant solid tumor subjects.
- Being tested
- GQ1005
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GQ1005Drug
an antibody drug conjugate
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | GQ1005 will be administered intravenously every 21 days. Dose Escalation will be guided by Bayesian Optimal Interval (BOIN) Design.
Multiple dose grouping Receives: Drug: GQ1005 |
| Dose Expansion | Experimental | GQ1005 at the recommended phase II dose (RP2D) will be administered intravenously every 21 days. Dose expansion will further evaluate the MTD or RP2D in different types of malignant solid tumor in four cohorts. Receives: Drug: GQ1005 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Adverse Events (AEs)
Incidence and severity of Treatment-emergent adverse events, treatment-related adverse events and serious adverse events, according to NCI-CTCAE Version 5.0 (The number of participants who had treatment-related side effects in population who had received one therapy at least).
Measured: Up to 2 years
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.
Measured: From first dose to the end of Cycle 1, 21 days
Maximal Tolerance Dose (MTD) or recommended phase II dose (RP2D)
The SRC will also determine the MTD/RP2D based on the totality of data for all tested dose levels.
Measured: After each cohort completes the DLT observation period (Day 1 to Day 21 after the first dose of study treatment) or has a DLT or becomes not DLT-evaluable
Secondary outcomes (10)
Maximum concentration (Cmax) of GQ1005
The pharmacokinetics(PK) profile of GQ1005
Measured: Up to2 years
Time of peak plasma concentration (Tmax)
The pharmacokinetics(PK) profile of GQ1005
Measured: Up to2 years
Area under the plasma concentration time curve (AUC) of GQ1005
The pharmacokinetics(PK) profile of GQ1005
Measured: Up to 2 years
Overall response rate (ORR)
The objective response rate will be analyzed according to the RECIST 1.1 standard tumor evaluation
Measured: Up to 2 years
Duration of Response (DoR)
DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death
Measured: Up to 2 years
Disease control rate (DCR)
DCR is defined as the rate of the sum of CR, PR and SD according to the RECIST 1.1 standard tumor evaluation.
Measured: Up to 2 years
Time-to-response (TTR)
To preliminarily evaluate TTR in patients with advanced solid tumors
Measured: Up to 2 years
Progression-free survival (PFS)
Progression free survival (PFS) refers to the time from the date of first administration to the first researcher's evaluation of disease progression or death (calculated by the event that occurred first). The disease progression will be evaluated by the researchers according to the RECIST 1.1 standard
Measured: Up to 2 years
Overall Survival (OS)
Overall survival (OS) refers to the time from the date of first administration to (for any reason) death. The disease progression will be evaluated by the researchers according to the RECIST 1.1 standard
Measured: Up to 2 years
Immunogenicity (anti-drug antibody ADA)
Percentage of subjects producing detectable anti-drug antibodies (ADA)
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start23 Nov 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2 Expressing or Mutated Advanced Malignant Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GeneQuantum Healthcare (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06154343
- Sponsor's protocol ID
- GQ1005-102
- Status last verified
- Nov 2023
- First submitted
- 23 Nov 2023
- Last updated
- 4 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-In-Human, Multicenter, Open-Label,Dose-Escalation and Extension Study of GQ1005 in Subjects With HER2-Expressing Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06154343
- Acronym / sponsor ID
- GQ1005-102
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- GeneQuantum Healthcare (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Nov 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 4 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, phase I study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of GQ1005 and preliminary anti-tumor efficacy in HER2 expressing or mutated advanced malignant solid tumor subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: GQ1005GQ1005 will be administered intravenously every 21 days. Dose Escalation will be guided by Bayesian Optimal Interval (BOIN) Design. Multiple dose grouping |
| Dose Expansion | Experimental | Drug: GQ1005GQ1005 at the recommended phase II dose (RP2D) will be administered intravenously every 21 days. Dose expansion will further evaluate the MTD or RP2D in different types of malignant solid tumor in four cohorts. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- The general inclusion criteria for dose escalation in Part 1 and dose expansion in Part 2 are as follows:
- Voluntary agreement to provide written informed consent；
- Aged 18 years or older, both male and female.
- The expected survival time is more than 3 months.
- ECOG performance status Score 0 or 1.
Key exclusion criteria (20 listed)
- Subjects must not meet any of the following exclusion criteria to be enrolled in the study.
- Clinically active brain metastases, defined as untreated and symptomatic, or requiring treatment with steroids or anticonvulsants to control associated symptoms. Subjects with treated asymptomatic brain metastases who do not require steroid therapy may be included in the study if they have recovered from the acute toxicity of radiation therapy.
- Cardiovascular dysfunction or clinically significant cardiac conditions, including but not limited to:
- Clinically significant acute and chronic lung disease. (e.g., interstitial pneumonia, pulmonary infection, pulmonary fibrosis, and severe radiation pneumonitis), or subjects with suspected pulmonary disease based on imaging at screening, or subjects requiring oxygen.
- People with known hypersensitivity to recombinant humanized anti-HER2 monoclonal antibody-DXd conjugate drugs and their components or to humanized monoclonal antibody products.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GQ1005an antibody drug conjugate | Drug | Dose Escalation, Dose Expansion |
Primary outcome
Incidence and Severity of Adverse Events (AEs)
Time frame: Up to 2 years
Incidence and severity of Treatment-emergent adverse events, treatment-related adverse events and serious adverse events, according to NCI-CTCAE Version 5.0 (The number of participants who had treatment-related side effects in population who had received one therapy at least).
Dose Limiting Toxicities (DLTs)
Time frame: From first dose to the end of Cycle 1, 21 days
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.
Maximal Tolerance Dose (MTD) or recommended phase II dose (RP2D)
Time frame: After each cohort completes the DLT observation period (Day 1 to Day 21 after the first dose of study treatment) or has a DLT or becomes not DLT-evaluable
The SRC will also determine the MTD/RP2D based on the totality of data for all tested dose levels.
10 secondary outcomes
Maximum concentration (Cmax) of GQ1005
Time frame: Up to2 years
Time of peak plasma concentration (Tmax)
Time frame: Up to2 years
Area under the plasma concentration time curve (AUC) of GQ1005
Time frame: Up to 2 years
Overall response rate (ORR)
Time frame: Up to 2 years
Duration of Response (DoR)
Time frame: Up to 2 years
Disease control rate (DCR)
Time frame: Up to 2 years
Time-to-response (TTR)
Time frame: Up to 2 years
Progression-free survival (PFS)
Time frame: Up to 2 years
Overall Survival (OS)
Time frame: Up to 2 years
Immunogenicity (anti-drug antibody ADA)
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GQ1005 in people with HER2 Expressing or Mutated Advanced Malignant Solid Tumors, run by GeneQuantum Healthcare (Suzhou) Co., Ltd. at 20 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Shi (0512-66526166, shiy@genequantum.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Severity of Adverse Events (AEs) (time frame: Up to 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2023.