Advanced/ Metastatic Her-2 Positive Breast CancerPhase 1/2NCT05575804

GQ1001 Combined With Pyrotinib for Treatment With HER2 Positive Metastatic Breast Cancer

A Phase 1/2 study testing GQ1001+pyrotinib in people with Advanced/ Metastatic Her-2 Positive Breast Cancer, run by Fudan University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

The aim of this trial is to study the safety, pharmacokinetics and preliminary efficacy of the HER2-targeted antibody-drug conjugate GQ1001 in combination with pyrotinib in patients with HER2-positive metastatic breast cancer patients who had failed previous anti-HER2 treatment. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Advanced/ Metastatic Her-2 Positive Breast Cancer
What is being tested?: GQ1001+pyrotinib
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteChina
Study dates: 1 Oct 2022to 31 Dec 2028
Phase: Phase 1/2
Are there results?: Not yet: the study is under way

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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Having provided written informed consent, and be able to follow clinical trial protocol.
Men or women aged 18-75.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1，life expectancy greater than 3 months.
Left ventricular ejection fraction (LVEF) ≥50%.
Histopathological and/or cytological confirmed Her2-positive locally advanced or metastatic breast cancer (IHC3+, or IHC2+ and ISH+), *ISH: Fluorescence in situ hybridization (FISH) or dual in situ hybridization (DISH); ISH positivity is defined as a ratio of HER2 gene copy number to CEP17 signal number ≥2.0. When the immunohistochemical (IHC) result is 3+, ISH testing is not required. When the IHC result is 2+, ISH testing should be performed to confirm HER2 positivity.
Failure for at least 1 line of standard systemic treatment for metastatic disease. Meet one of the following conditions:

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Recurrent within 12 months after completing or during neoadjuvant/ adjuvant therapy (the regimens contain trastuzumab or its biosimilar with pertuzumab or not).
Received at least one treatment with trastuzumab or its biosimilar ±pertuzumab (monotherapy or in combination with other drugs) for recurrent or metastatic disease.
Having at least one measurable lesion according to RECIST 1.1.
Previous exposure to taxanes.
During the screening period and the first 7 days before treatment, the following indicators confirm appropriate organ functions:
Hematology: WBC≥3.0×109/L；NE≥1.5×109/L；Hb≥90 g/L；Plt≥100×109/L;
Liver function: Total bilirubin ≤ 1.5 x the upper limit of normal; AST and ALT ≤ 2.5 x the upper limit of normal, ≤ 5.0 x the upper limit of normal in the presence of liver metastases;
Kidney function: Serum creatinine ≤1.5 x the upper limit of normal;
Coagulation function: prothrombin time and activated partial thromboplastin time ≤1.5 x the upper limit of normal.
Adequate wash-out periods:
Major surgery ≥4 weeks;
Radiotherapy ≥4 weeks (Palliative stereotactic radiotherapy without abdominal involvement radiotherapy: ≥2 weeks);
Autologous transplantation: ≥3 months
targeted therapy or chemotherapy≥4 weeks;
Radioactive particle therapy: ≥3 months
Nuclide therapy: ≥3 months
Hormone therapy: ≥2 weeks, or based on judgement on the breast cancer
Participants from the investigators' judgment;
Endocrine therapy: ≥4weeks;
Chemotherapy or targeted therapy: 5-fluorouracil-based preparations, folinic acid preparations, and/or Weekly paclitaxel: ≥2 weeks;
Tyrosine kinase inhibitor: ≥2 weeks (or 5 half-lives)
In the case of a decline period, the longer one shall prevail;
Nitrosoureas or mitomycin C: ≥6 weeks
Immunotherapy ≥4 weeks;
Potent CYP3A4 inhibitor≥3*t1/2 weeks;
Any investigational agents≥4 weeks.
Female subjects who are capable of bearing children must have negative urine or serum pregnancy test results within 7 days before randomization, and must commit to using contraception throughout the study period and continue to do so for 7 months after the study ends.

Who cannot join

Clinical symptomatic brain metastasis is defined as untreated and symptomatic, or requiring steroid or anticonvulsant treatment to control related symptoms. Patients with asymptomatic brain metastasis, or with stable clinical symptoms and no need for steroid hormone and other treatments for brain metastasis for ≥28 days, can be enrolled.
Have previously been treated with: another antibody-drug conjugate (ADC) consisting of DM1 or its derivative，pyrotinib and capecitabine，except for the following situations:
During (neo)adjuvant therapy, received pyrotinib, and the participants who have experienced recurrence or metastasis more than 6 months after the last treatment and have not received pirlotinib since then are allowed to be enrolled;
Participants who have received pirlotinib treatment during the recurrent and metastatic stage, discontinued the medication due to reasons other than disease progression, and have progressed more than 6 months after discontinuation are allowed to be enrolled;
Participants who have received treatment with ADC drugs with different small molecule toxins (such as DS-8201, GQ1005, SHR-A1811, etc.) are eligible for enrollment. Such patients are also allowed to have received pirlotinib treatment during the recurrent or metastatic stage, and those who have progressed after more than 6 months of pirlotinib treatment are also eligible for enrollment.
Have other malignant tumors within 5 years before signing the informed consent form ( except for cured skin basal cell carcinoma and cervical carcinoma in situ).

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Have a medical history of myocardial infarction or clinically significant heart diseases, including but not limited to,
symptomatic congestive heart failure (CHF) (NYHA classes II-IV), or serious cardiac arrhythmia which required to therapy;
Having a history of myocardial infarction or unstable angina pectoris within 6 months prior to the initial treatment,
Have a corrected QT interval (QTc) prolongation to > 450 milliseconds (ms) in males and > 470 ms in females.
Have clinically significant acute and chronic pulmonary diseases (e.g. interstitial lung disease (ILD), lung infection, pulmonary fibrosis, and severe radiation pneumonitis), participants with a history of ILD/non-infectious pneumonia requiring hormone therapy, or suspected of having lung diseases based on imaging examination at screening, with imaging suggesting miliary disseminated metastasis, subjects with specific pulmonary complications including but not limited to any potential lung diseases (such as pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, or other conditions that may interfere with the detection or management of drug-related pulmonary toxicity within 3 months prior to enrollment in the study), or subjects requiring oxygen therapy.
History of allergic reaction to any component of GQ1001.
The toxicity of previous anti-cancer therapy has not recovered to ≤1 as specified in CTCAE v5.0 (except for hair loss); e.g. chronic grade 2 toxicity might be determined per the investigator's judgment.
The cumulative dose of anthracyclines or equivalent>500 mg/m2.
Uncontrollable infections require intravenous antibiotics, antiviral drugs, or antifungal drugs.
Hepatitis B virus (HBV) infection (including hepatitis B surface antigen [HBsAg] positive or hepatitis B core antibody [HBcAb] positive and HBV DNA positive); HIV, syphilis, hepatitis C antibody positive, or other severe and fatal viral or bacterial diseases, except for patients with stable hepatitis B (HBV viral copy number below the upper limit of reference value) after drug treatment and cured hepatitis C patients (HCV viral copy number below the detection limit of assay method).
Per the investigator's judgment, participants with any history or current evidence of concomitant disease treatment or laboratory abnormalities may interfere with the trial results, as well as their participation and compliance.
Lactating women or women who have confirmed pregnancy through a pregnancy test within 7 days prior to their first treatment.
Male or female subjects unwilling to use approved contraceptive methods (e.g. birth control pills, barrier device, intrauterine device, abstinence) during the study and for 7 months following the last dose of the study drug infusion.
Other circumstances that are deemed not appropriate for the study.
Inability to swallow, chronic diarrhea and intestinal obstruction, or other factors that affect drug administration and absorption.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Biyun Wang contact

18017312387

pro_wangbiyun@163.com

China1 site, 1 recruiting

Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Biyun Wang, 18017312387, pro_wangbiyun@163.com
Recruiting

Other trials in China

About this study

Official title: Phase Ib/II Study of GQ1001 and Pyrotinib in HER2 Positive Metastatic Breast Cancer Patients Who Had Failed Previous Anti-HER2 Treatment（GRACE）

Conditions: Advanced/ Metastatic Her-2 Positive Breast Cancer
Being tested: GQ1001+pyrotinib
Keywords: HER2-ADC, pyrotinib, Advanced/ Metastatic Her-2 positive Breast Cancer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GQ1001+pyrotinibDrug
GQ1001 infusions on day 1 of each 21-day cycle combinate with pyrotinib 320mg orally once daily until disease progression or unacceptable toxicity. I.

Study groups in NCT05575804
Study group	Role	What they receive
experimental group	Experimental	Patients will receive the recommended phase II dose of GQ1001 determined in phase I. GQ1001 infusions on day 1 of each 21-day cycle combinate with pyrotinib 320mg orally once daily until disease progression or unacceptable toxicity. Receives: Drug: GQ1001+pyrotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

Dose-limiting toxicities (DLTs), Phase I
Side effects of drug or treatment that are serious enough to prevent an increase in dose or level of that treatment, according to NCI-CTCAE Version 5.0.
Measured: From the first dose to the end of Cycle 1, 21 days
Maximum Tolerated Dose (MTD), Phase I
Highest administered dose with < 33% of participants experiencing dose-limiting toxicity (DLT) in the first 6 DLT evaluable participants.
Measured: From the first dose to the end of Cycle 1, 21 days
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
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 the population who had received one therapy at least).
Measured: up to 24 months
Objective Response Rate (ORR), Confirmed by the researcher's evaluation, Phase II
The objective response rate will be analyzed according to the RECIST 1.1 standard tumor evaluation.
Measured: up to 24 months

Secondary outcomes (7)

Maximum Serum Concentration (Cmax), Phase I
Maximum Serum Concentration (Cmax) of GQ1001, DM1, pyrotinib, and total anti-HER2 antibody
Measured: At the end of Cycle 3 (each cycle is 21 days)
Trough Serum concentration (Cthough), Phase I
Trough Serum concentration (Cthough) of GQ1001, DM1, pyrotinib, and total anti-HER2 antibody
Measured: At the end of Cycle 3 (each cycle is 21 days)
Area Under the Concentration-time Curve (AUC), Phase I
Area Under the Concentration-time Curve (AUC) of GQ1001, DM1, pyrotinib, and total anti-HER2 antibody
Measured: At the end of Cycle 3 (each cycle is 21 days)
Objective Response Rate (ORR), Phase I
The objective response rate will be analyzed according to the RECIST 1.1 standard tumor evaluation.
Measured: up to 24 months
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 24 months
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 24 months
PFS
Progression-free survival (PFS) refers to the time from the date of randomization 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 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 202231 Dec 2028

First posted12 Oct 2022
Study start1 Oct 2022
Primary completion31 Dec 2028 (estimated)
Study completion31 Dec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced/ Metastatic Her-2 Positive Breast CancerStudies of the same condition, open and under way.
More trials run by Fudan UniversityThe sponsor's other registered studies.
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 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 32 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05575804
Sponsor's protocol ID: GRACE
Status last verified: Jul 2026
First submitted: 5 Oct 2022
Last updated: 24 Jul 2026
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 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase Ib/II Study of GQ1001 and Pyrotinib in HER2 Positive Metastatic Breast Cancer Patients Who Had Failed Previous Anti-HER2 Treatment（GRACE）
ClinicalTrials.gov ID: NCT05575804
Acronym / sponsor ID: GRACE
Conditions: Advanced/ Metastatic Her-2 Positive Breast Cancer
Keywords: HER2-ADC, pyrotinib, Advanced/ Metastatic Her-2 positive Breast Cancer
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 32 participants (estimated)
Lead sponsor: Fudan UniversityUniversity, hospital or other
Collaborators: GeneQuantum Healthcare (Suzhou) Co., Ltd.
Study start: 1 Oct 2022 (actual)
Primary completion: 31 Dec 2028 (estimated)
Study completion: 31 Dec 2028 (estimated)
First posted: 12 Oct 2022 (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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
experimental group	Experimental	Drug: GQ1001+pyrotinibPatients will receive the recommended phase II dose of GQ1001 determined in phase I. GQ1001 infusions on day 1 of each 21-day cycle combinate with pyrotinib 320mg orally once daily until disease progression or unacceptable toxicity.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (33 listed)

Having provided written informed consent, and be able to follow clinical trial protocol.
Men or women aged 18-75.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1，life expectancy greater than 3 months.
Left ventricular ejection fraction (LVEF) ≥50%.
Histopathological and/or cytological confirmed Her2-positive locally advanced or metastatic breast cancer (IHC3+, or IHC2+ and ISH+), *ISH: Fluorescence in situ hybridization (FISH) or dual in situ hybridization (DISH); ISH positivity is defined as a ratio of HER2 gene copy number to CEP17 signal number ≥2.0. When the immunohistochemical (IHC) result is 3+, ISH testing is not required. When the IHC result is 2+, ISH testing should be performed to confirm HER2 positivity.

Key exclusion criteria (21 listed)

Clinical symptomatic brain metastasis is defined as untreated and symptomatic, or requiring steroid or anticonvulsant treatment to control related symptoms. Patients with asymptomatic brain metastasis, or with stable clinical symptoms and no need for steroid hormone and other treatments for brain metastasis for ≥28 days, can be enrolled.
Have previously been treated with: another antibody-drug conjugate (ADC) consisting of DM1 or its derivative，pyrotinib and capecitabine，except for the following situations:
Have other malignant tumors within 5 years before signing the informed consent form ( except for cured skin basal cell carcinoma and cervical carcinoma in situ).
Have a medical history of myocardial infarction or clinically significant heart diseases, including but not limited to,
Have clinically significant acute and chronic pulmonary diseases (e.g. interstitial lung disease (ILD), lung infection, pulmonary fibrosis, and severe radiation pneumonitis), participants with a history of ILD/non-infectious pneumonia requiring hormone therapy, or suspected of having lung diseases based on imaging examination at screening, with imaging suggesting miliary disseminated metastasis, subjects with specific pulmonary complications including but not limited to any potential lung diseases (such as pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, or other conditions that may interfere with the detection or management of drug-related pulmonary toxicity within 3 months prior to enrollment in the study), or subjects requiring oxygen therapy.

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
GQ1001+pyrotinibGQ1001 infusions on day 1 of each 21-day cycle combinate with pyrotinib 320mg orally once daily until disease progression or unacceptable toxicity. I.	Drug	experimental group

Primary outcome

Dose-limiting toxicities (DLTs), Phase I
Time frame: From the first dose to the end of Cycle 1, 21 days
Side effects of drug or treatment that are serious enough to prevent an increase in dose or level of that treatment, according to NCI-CTCAE Version 5.0.
Maximum Tolerated Dose (MTD), Phase I
Time frame: From the first dose to the end of Cycle 1, 21 days
Highest administered dose with < 33% of participants experiencing dose-limiting toxicity (DLT) in the first 6 DLT evaluable participants.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: up to 24 months
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 the population who had received one therapy at least).
Objective Response Rate (ORR), Confirmed by the researcher's evaluation, Phase II
Time frame: up to 24 months
The objective response rate will be analyzed according to the RECIST 1.1 standard tumor evaluation.

7 secondary outcomes

Maximum Serum Concentration (Cmax), Phase I
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Trough Serum concentration (Cthough), Phase I
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Area Under the Concentration-time Curve (AUC), Phase I
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Objective Response Rate (ORR), Phase I
Time frame: up to 24 months
Duration of Response (DoR)
Time frame: up to 24 months
Disease Control Rate (DCR)
Time frame: up to 24 months
PFS
Time frame: up to 24 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.

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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.

Biyun Wang contact

18017312387

pro_wangbiyun@163.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GQ1001+pyrotinib in people with Advanced/ Metastatic Her-2 Positive Breast Cancer, run by Fudan University at 1 site 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 33 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Biyun Wang (18017312387, pro_wangbiyun@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicities (DLTs), Phase I (time frame: From the first dose to the end of Cycle 1, 21 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05575804.

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 24 Jul 2026.