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HER2-expressing Advanced Solid TumorsPhase 1/2NCT06015048

A Trial of SHR-A1811 Combined With Other Antitumor Therapies in Advanced Solid Tumors.

A Phase 1/2 study testing SHR-A1811 combined with Pyrotinib. and SHR-A1811 combined with other antitumor therapies in people with HER2-expressing Advanced Solid Tumors, run by Jiangsu HengRui Medicine Co., Ltd. at 15 sites 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 study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A1811 combined with other antitumor therapies in advanced solid tumors. To explore the reasonable dosage of SHR-A1811 combined with other antitumor therapies for advanced solid tumors. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
HER2-expressing Advanced Solid Tumors
What is being tested?
SHR-A1811 combined with Pyrotinib. and SHR-A1811 combined with other antitumor therapies
Could I receive a placebo?
No, everyone receives an active treatment
How many people
364 participants
Where
15 sitesChina
Study dates
11 Aug 2023to 29 Dec 2026
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

  • Able and willing to provide a written informed consent. Have good compliance and cooperated with follow-up visits.
  • Subjects are older than or equal to 18 years old and younger than or equal to 75 years old on the day of signing the informed consent. Male or female.
  • ECOG score 0-1.
  • Life expectancy is at least 12 weeks.
  • Histologically or cytologically confirmed metastatic or advanced unresectable HER2-expression or Her-2 functional mutations solid tumors.
  • Provide ≥ 6(or ≥8)sections of formalin-fixed, paraffin-embedded tumor tissue blocks or unstained tumor specimen sections. Sections should be archived within 1 year before the first study treatment or freshly obtained (freshly obtained is preferred).
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  • ≥1 Measurable lesions, according to the Response Evaluation Criteria for Solid Tumors (RECIST) version 1.1. The dose escalation phase allows for the absence of measurable lesions.
  • Organ function met criteria within 7 days prior to initial administration (No blood component or cell growth factor was used within 14 days before the initial administration):
  • Left ventricular ejection fraction (LVEF) ≥ 50% at baseline within 28 days prior to initial administration.
  • Males and women of childbearing age must use reliable contraception from the written informed consent to 7 months after last drug administration (SHR-A1811) or 8 weeks after last drug administration (Pyrotinib) or 6 months after last drug administration (BP102 or Oxaliplatin or Calcium levonofolinate or fluorouracil), the latest time should be taken as final. Women of childbearing age must have had a pregnancy test (serum or urine) with negative results within 7 days prior to initial administration and must not in lactation period.

Who cannot join

  • Subjects with untreated or known active CNS metastasis. Subjects with a history of meningeal metastasis or known active meningeal metastasis.
  • Have a history of antibody drug conjugate with following characteristics: topoisomerase I inhibitors, including Enhertu (DS-8201a), U3-1402, etc. Part A: Have a history of Her-2 targeted tyrosine-kinase inhibitor (TKI).
  • Palliative radiotherapy within 14 days prior to initial administration. Subjects who had received systemic anti-tumor therapy within 4 weeks prior to initial administration will not permitted. The interval between the end of small-molecule targeted drugs administration and initial test drug administration must be ≥ 5 half-lives or 7 days (take the longer time). The interval between the end of Chinese patent anti-tumor drug administration and initial test drug administration must be ≥ 2 weeks. Participating in another clinical study of other drugs. The interval between the previous clinical study drug use and this study initial administration is less than 4 weeks or 5 half-lives of previous clinical study drug (take the shorter time).
  • Toxicity and/or complications of previous interventions were not recovered to NCI-CTCAE ≤ grade 1 or didn't meet this inclusion criteria and exclusion criteria. If investigator determines that the toxicity and/or complications are NCI-CTCAE ≤ grade 2 and there is no safety risk, this subject can be enrolled. For example, patients with type 1 diabetes or hypothyroidism who have been treated with immune checkpoint inhibitors and are stable after hormone replacement therapy.
  • Have a history of (non-infectious) interstitial lung disease (ILD). Suspected ILD. Other moderate and severe lung diseases that may interfere the detection or management of drug-related pulmonary toxicity and severely affect respiratory function within 3 months before the first test drug administration. Any autoimmune disease, connective tissue disease, or inflammatory disease with lung involvement.
  • Patients unable to swallow orally administered medication and other disorders likely to interfere the absorption of the study drugs within 28 days before the first test drug administration.
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  • Patients with moderate and severe ascites of clinical symptoms Refractory or moderate to severe pleural effusion or pericardial effusion.
  • Patients with intestinal obstruction within 6 months prior to the first test drug administration or presence of signs and symptoms of intestinal obstruction (patients can be enrolled if surgical treatment had been performed and the obstruction had been completely resolved).
  • Have clinically significant cardiovascular disease.
  • Previous or combined with other malignancies except those have achieved complete remission and do not require or are not expected to require other treatment during the study period within at least 5 years prior to screening, including basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, cervical carcinoma in situ, local prostate cancer, ductal carcinoma in situ after radical surgery, etc (hormone therapy for non-metastatic prostate cancer or breast cancer is allowed) .
  • Serious infections within 28 days prior to the first test drug administration. Active infections that had received therapeutic intravenous antibiotics within 2 weeks prior to the first test drug administration. Prophylactic antibiotic therapy can be enrolled.
  • Active hepatitis B or active hepatitis C infection. Active hepatitis B is defined as hepatitis B surface antigen (HBsAg) positive and HBV-DNA ≥10000 copies/ml [2000 IU/ml] during screening. Active hepatitis C is defined as hepatitis C virus antibody positive and HCV-RNA positive during screening. Patients with active pulmonary tuberculosis infection within 1 year before enrolment, or with a history of active pulmonary tuberculosis infection but without regular treatment more than 1 year before enrolment. Has known immunodeficiency disorders, including human immunodeficiency virus (HIV) infection, etc. Received attenuated live vaccines within 28 days of initial administration. Expected use of attenuated live vaccines during the study period.
  • Major surgery history other than diagnostic or biopsy surgery within 28 days prior to initial administration. Minor traumatic surgery within 7 days prior to initial administration. Non-healing wounds. Untreated bone fractures.
  • Known allergy to any component of SHR-A1811. History of severe allergic reactions to other monoclonal antibody/fusion protein drugs. Part A: known allergy to any component of Pyrotinib.
  • Female subjects who are pregnant, in lactation period, or planning pregnancy during the study period.
  • Uncontrolled mental illness and other conditions which will affect the completion of the study, such as alcohol abuse, drug or substance abuse, criminal detention, etc.
  • Any other conditions that may not eligible to participate in this study according to researchers' judgment.
  • For Part B1, subjects must not meet any of the following supplementary criteria at the same time, otherwise they will not be enrolled in the study:
  • 1、Presence of grade >1 peripheral neuropathy.
  • For those who plan to receive BP102 combination therapy, subjects must not meet any of the following supplementary criteria at the same time, otherwise they will not be enrolled in the study:
  • Bleeding tendency, coagulation dysfunction, or high risk of thrombosis.
  • Poorly controlled hypertension after medication (systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg in the case of regular anti-hypertensive therapy) and prior hypertensive crisis or hypertensive encephalopathy. Severe cerebrovascular diseases and clinically significant vascular diseases.
  • Severe cerebrovascular disease, including cerebrovascular accident (CVA), transient ischemic attack (TIA), and significant vascular disease (including but not limited to aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to enrollment;

Trial locations and contacts

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

Zhengjin Zhang contact

+0518-82342973

zhengjin.zhang.zz79@hengrui.com

15 sites in 1 country

China15 sites, 15 recruiting

  • Peking University Cancer Hospital & Institute-Department of Gastrointestinal Oncology

    Beijing, Beijing Municipality, 100142

    Lin Shen

    Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410031

    Zhenyang Liu

    Recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400016

    Tao Zhang

    Recruiting

  • Harbin Medical University Cancer Hospital-The Eighth Department of Internal Medicine

    Harbin, Heilongjiang

    Yanqiao Zhang

    Recruiting

  • Anhui Provincial Hospital

    Hefei, Anhui, 230001

    Yubei Sun

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

    Xiaodong Peng

    Recruiting

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330200

    Hua Wang

    Recruiting

  • Guangxi Medical University Affiliated Tumor Hospital

    Nanning, Guangxi, 530021

    Yongqiang Li

    Recruiting

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

    Fengbing Zhang

    Recruiting

  • Shanxi Provincial Cancer Hospital-Gastroenterology Department

    Taiyuan, Shanxi, 030013

    Wenhui Yang

    Recruiting

  • Tianjin Medical University Cancer Institute and Hospital-Department of digestive oncology

    Tianjin, Tianjin Municipality, 300060

    Hongli Li

    Recruiting

  • Hubei Cancer Hospital-Department of Abdominal Oncology

    Wuhan, Hubei, 430079

    Xinjun Liang

    Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi, 710061

    Aili Suo

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450003

    Yan Zhao

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University-Department of Medical Oncology

    Zhengzhou, Henan, 450052

    Hong zong

    Recruiting

Other trials in China

About this study

Official title: A Phase 1b/2 Study to Evaluate the Safety, Tolerability and Efficacy of SHR-A1811 Combined With Other Antitumor Therapies in Advanced Solid Tumors.

The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A1811 combined with other antitumor therapies in advanced solid tumors. To explore the reasonable dosage of SHR-A1811 combined with other antitumor therapies for advanced solid tumors.

Being tested
SHR-A1811 combined with Pyrotinib., SHR-A1811 combined with other antitumor therapies

What participants receive

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

  • SHR-A1811 combined with Pyrotinib.Drug

    SHR-A1811 combined with Pyrotinib

  • SHR-A1811 combined with other antitumor therapiesDrug

    SHR-A1811 combined with other antitumor therapies

Study groups in NCT06015048
Study groupRoleWhat they receive
Part A: Intervention: Drug: SHR-A1811 combined with PyrotinibExperimentalNot described
Receives: Drug: SHR-A1811 combined with Pyrotinib.
Part B1: Intervention: Drug: SHR-A1811 combined with other antitumor therapiesExperimentalNot described
Receives: Drug: SHR-A1811 combined with other antitumor therapies

What is being measured

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

  1. Part A: Maximally Tolerated Dose (MTD),)(Phase ⅠB).

    Measured: From the first dose to the last dose, about 11 months

  2. Part A: recommended phase 2 dose (RP2D)(Phase ⅠB).

    Measured: From the first dose to the last dose, about 11 months

  3. Part A: Adverse Events (Phase ⅠB)

    Measured: From the first dose to the last dose, about 11 months

  4. Part A: Objective Response Rate (ORR) (Phase Ⅱ)

    Measured: From the first dose to the last dose, about 11 months

Secondary outcomes (6)

  1. Part A: ORR (Phase ⅠB).

    Measured: From the first dose to the last dose, about 11 months.

  2. Part A: Disease Control Rate (DCR) (Phase ⅠB and Phase Ⅱ)

    Measured: From the first dose to the last dose, about 11 months

  3. Part A: Duration of Response (DoR) (Phase ⅠB and Phase Ⅱ)

    Measured: From the first dose to the last dose, about 11 months

  4. Part A: Progression-free survival (PFS) (Phase ⅠB and Phase Ⅱ)

    Measured: From the first dose to the last dose, about 13 months.

  5. Part A: Overall survival (OS) (Phase ⅠB and Phase Ⅱ)

    Measured: From the first dose to the last dose, about 13 months

  6. Part A: Adverse Events (PhaseⅡ).

    Measured: about 11 months.

Timeline

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

  1. First posted29 Aug 2023
  2. Study start11 Aug 2023
  3. Primary completionNov 2026 (estimated)
  4. Study completion29 Dec 2026 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
364 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06015048
Sponsor's protocol ID
SHR-A1811-208
Status last verified
Aug 2024
First submitted
1 Aug 2023
Last updated
5 Aug 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SHR-A1811 combined with Pyrotinib. and SHR-A1811 combined with other antitumor therapies in people with HER2-expressing Advanced Solid Tumors, run by Jiangsu HengRui Medicine Co., Ltd. at 15 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 10 inclusion and 23 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 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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 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 Zhengjin Zhang (+0518-82342973, zhengjin.zhang.zz79@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Maximally Tolerated Dose (MTD),)(Phase ⅠB). (time frame: From the first dose to the last dose, about 11 months). 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 NCT06015048.

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 5 Aug 2024.

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