Advanced Solid TumorPhase 1/2NCT05805956
IMM2902 in Patients With Advanced Solid Tumors Expressing HER2
A Phase 1/2 study testing IMM2902 in people with Advanced Solid Tumor and Advanced Lung Cancer, run by ImmuneOnco Biopharmaceuticals (Shanghai) Inc. at 2 sites in China.
Trial summary
This trial is an open-label, multicenter, first-in-human dose-escalation and cohort expansion Phase I/II clinical study to evaluate the safety, tolerability and preliminary efficacy of IMM2902 in the treatment of HER2-expressing advanced solid tumors Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumor, Advanced Lung Cancer, Advanced Gastric Carcinoma
- What is being tested?
- IMM2902
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 2 sitesChina
- Study dates
- 15 Feb 2022to Oct 2024
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily sign the Informed Consent Form (ICF) and follow the protocol requirements;
- Age ≥ 18 years old and ≤ 75 years old, regardless of gender;
- Expected survival time ≥ 12 weeks;
- HER2 expression:
- HER2 protein expression or HER2 gene amplification was found in primary or metastatic tumor tissue (IHC) or FISH.
- Phase I (dose escalation phase):
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- HER2 expression is defined as IHC1+, IHC2+ or IHC3+, FISH testing is not required, and testing results from local qualified medical institutions are acceptable.
- Phase II (cohort expansion phase):
- HER2 overexpression is defined as IHC 3+ or IHC 2+, which can be tested by local qualified medical institutions.
- Clinical diagnosis:
- Phase I (dose escalation phase):
- Patients with advanced solid tumors with HER2 expression (IHC1+, IHC2+ or IHC3+) confirmed by histology or cytology, who have previously received standard treatment progress, treatment ineffective or no standard treatment plan, including but not limited to breast cancer, gastric cancer (including gastroesophageal combination adenocarcinoma), urothelial carcinoma, biliary tract carcinoma, ovarian cancer, colon cancer and non-small cell lung cancer.
- Phase II (cohort expansion phase), including 3 cohorts:
- Cohort 1: Histologically or cytologically confirmed unresectable locally advanced or metastatic non-small cell lung cancer with HER2 overexpression (IHC3+ or IHC2+), who have previously failed systemic therapy; Cohort 2: Unresectable locally advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma) with histologically or cytologically confirmed HER2 overexpression (IHC3+ or IHC2+), who have previously received at least two systemic regimens.
- Cohort 3: Unresectable locally advanced or metastatic biliary tract cancer with histologically or cytologically confirmed HER2 overexpression (IHC3+ or IHC2+), recurrence or disease progression after previous standard treatment.
- Patients included in the Phase II study need to provide previous HER2 test results, or archive tumor tissue to detect HER2 expression status. If neither is available, the patient may undergo a new tumor biopsy.
- According to the evaluation criteria for solid tumors (RECIST v1.1), measurable lesions (longest diameter of spiral CT scan ≥ 10 mm, if the lesion is a lymph node, the short axis ≥ 15 mm; and the lesion has not received radiotherapy, unless the lesion clear progress); Phase I (dose escalation phase): Evaluable lesions (target lesions or non-target lesions); Phase II (Cohort Expansion Phase): Measurable lesions (target lesions) according to RECIST v1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) score 0 or 1;
- Adequate organ and coagulation function
- AE related to previous systemic chemotherapy, radical/extensive radiotherapy or other antineoplastic drug treatment recovered to (NCI CTCAE v5.0)≤ Grade 1 (except for non-clinically significant or asymptomatic laboratory abnormalities), Patients with controlled grade 2 hypothyroidism and hyperglycemia may be enrolled after consultation with the sponsor;
- Cumulative dose of anthracycline doxorubicin ≤360mg/m2 or its equivalent dose, epirubicin ≤720mg/m2;
- 10. Patients of childbearing age must take effective contraceptive measures during the study to within 6 months after the last dose.
Who cannot join
- Received the last systemic or local anti-tumor therapy within 4 weeks before the first administration, including chemotherapy, immunotherapy, biological agents, etc.; received hormone anti-tumor therapy, small molecule targeted therapy within 2 weeks before the first administration; Palliative local treatment for non-target lesions within 2 weeks before the first administration; received non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, tumor necrosis factor, etc., not including IL-11 for the treatment of thrombocytopenia); Chinese herbal medicine or Chinese patent medicine with anti-tumor indications within 1 week before the first administration.
- Received therapeutic drugs targeting SIRPα/CD47 4 weeks before the first administration, such as CD47 antibody, SIRPα fusion protein, SIRPα antibody and SIRPγ fusion protein;
- Patients with primary central nervous system (CNS) malignant tumors or active CNS metastases who have failed local treatment (radiotherapy or surgery), but the following patients are allowed to enroll: a. Asymptomatic brain metastases; b. Clinical symptoms are stable (that is, there is no imaging progress 4 weeks before the first administration, and any neurological symptoms have returned to the baseline level), and corticosteroids and other treatments for brain metastases are not required for ≥4 weeks;
- Uncontrolled hypertension (systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90mmHg) or pulmonary hypertension or unstable angina pectoris; myocardial infarction or bypass or stent surgery within 6 months before administration; Chronic heart failure history of grade III-IV of NYHA criteria; clinically significant valvular disease; serious arrhythmia requiring treatment (except atrial fibrillation, paroxysmal supraventricular tachycardia), including male QTc ≥ 450ms, Female QTc≥470ms (calculated by Fridericia formula); cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 12 months before enrollment;
- History of arterial thrombosis, deep vein thrombosis and pulmonary embolism within 3 months before the first administration;
- Have a history of moderate or severe dyspnea at rest due to advanced malignant tumors or their complications or severe primary lung diseases, or currently require continuous oxygen therapy, or currently suffer from interstitial lung disease (ILD), severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc.;
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- Suffering from other malignant tumors within 5 years before the first administration. Except: a. Cervical carcinoma in situ or non-melanoma skin cancer that has been radically cured; b. Second primary cancer that has been radically cured and has no recurrence within five years; c. The investigators believe that both primary cancers can benefit from this study;
- Diseases that may cause gastrointestinal bleeding or perforation (such as duodenal ulcer, intestinal obstruction, acute Crohn's disease, ulcerative colitis, large-scale gastric and small intestinal resection, etc.); patients with chronic Crohn's disease and patients with ulcerative colitis (except those with total colon and rectal resection), even in the inactive phase, should be excluded; those with hereditary nonpolyposis colorectal cancer or familial adenomatous polyposis syndrome; Perforation, intestinal fistula history, but not cured after surgical treatment; esophageal and gastric varices;
- Need puncture and drainage to treat uncontrollable pleural, abdominal and pericardial effusions that require repeated drainage or have obvious symptoms;
- Have active hepatitis B [hepatitis B virus surface antigen (HBsAg) positive and/or hepatitis B virus antibody (HBcAb) positive, and HBV DNA ≥ 2000 IU/ml, and hepatitis caused by drugs or other reasons is excluded], or active hepatitis C [anti-hepatitis C virus (HCV) antibody positive, and HCV RNA is higher than the lower limit of detection, and hepatitis caused by drugs or other causes is excluded];
- Has a history of immunodeficiency, including human immunodeficiency virus (HIV) infection, or other immunodeficiency diseases, or has a history of organ transplantation;
- Have a history of autoimmune diseases, including but not limited to systemic lupus erythematosus, psoriasis, rheumatoid arthritis, inflammatory bowel disease, Hashimoto's thyroiditis, autoimmune thyroid disease, multiple sclerosis, etc. patient. except:
- Hypothyroidism that can be controlled only by hormone replacement therapy;
- Skin diseases that do not require systemic treatment (such as vitiligo, and psoriasis);
- Controlled celiac disease. However, patients who are using immunosuppressants or systemic hormone therapy (prednisone or other equivalent hormones at a dose ≥ 10 mg/day) and continue to use them within 2 weeks before enrollment cannot be enrolled;
- Evidence of uncontrollable severe active infection (such as sepsis, bacteremia, viremia, etc.);
- Have a history of allergies of grade 3 or above to any component or excipient of the study drug; or have a history of allergic reactions of grade 3 or above to trastuzumab or other anti-HER2 targeted drugs (CTCAE v5.0 classification);
- Received anti-tumor vaccine treatment 4 weeks before the first administration or plan to receive anti-tumor vaccine trial;
- Have undergone major surgery within 4 weeks before the first administration and have not fully recovered, or plan to undergo major surgery in the first 12 weeks after receiving the study drug; have received minor surgery (including catheterization) 2 days before enrollment, except for central venous catheterization via peripheral venipuncture);
- Those who have a clear history of neurological or mental disorders, such as epilepsy, dementia, and poor compliance;
- Has a history of alcoholism or drug abuse in the past 1 year;
- Serum pregnancy test positive or breastfeeding women; do not agree to take adequate contraceptive measures during the study period and within 6 months after receiving the test drug;
- Patients who have participated in other clinical studies in the past shall be out of the group in accordance with original clinical studies and more than 4 weeks prior to the first administration of this study;
- Other situations where investigators believe they are inappropriate for participation in this study.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
301 Hospital
Beijing
Jianming Xu
- Recruiting
Fudan University Cancer Hospital
Shanghai
Jiong Wu
About this study
Official title: An Open-label, Multicenter, First-in-human Dose-escalation and Cohort Expansion Phase I/II Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of IMM2902 in the Treatment of HER2-expressing Advanced Solid Tumors
This trial is an open-label, multicenter, first-in-human dose-escalation and cohort expansion Phase I/II clinical study to evaluate the safety, tolerability and preliminary efficacy of IMM2902 in the treatment of HER2-expressing advanced solid tumors
- Conditions
- Advanced Solid Tumor, Advanced Lung Cancer, Advanced Gastric Carcinoma, Advanced Cholangiocarcinoma
- Being tested
- IMM2902
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMM2902Drug
a recombinant bispecific monoclonal antibody with high affinity to the dual targets, HER2 and CD47
| Study group | Role | What they receive |
|---|---|---|
| IMM2902 | Experimental | Phase 1 is the dose escalation part, patients with HER2 expressing solid tumors will be enrolled in groups of different dose levels, to explore MTD, RP2D, safety, and preliminary efficacy of IMM2902.
Phase 2 is the cohort expansion part, patients with HER2 overexpressing advanced solid tumors will be enrolled in three cohorts, to explore the safety and efficacy of IMM2902. Receives: Drug: IMM2902 |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum tolerated dose (MTD) of IMM2902
Observe the safety and tolerability of IMM2902 in patients with advanced solid tumors expressing human epidermal growth factor receptor 2 (HER2), so as to determine the MTD
Measured: 48 weeks
recommended phase 2 dose (RP2D) of IMM2902
Observe the safety and tolerability of IMM2902 in patients with advanced solid tumors expressing human epidermal growth factor receptor 2 (HER2), so as to determine the RP2D
Measured: 48 weeks
Treatment-related adverse events as assessed by CTCAE v5.0
To evaluate the safety of IMM2902
Measured: 48 weeks
objective response rate
proportion of subjects whose tumors achieved CR and PR after treatment
Measured: 48 weeks
disease control rate
the proportion of subjects whose tumors achieved CR, PR and SD after treatment
Measured: 48 weeks
duration of response
the time from the beginning of recording an objective response to the first occurrence of tumor progression, or death from any cause
Measured: 48 weeks
progression-free survival
the time from the start of treatment to tumor progression or death from any cause
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start15 Feb 2022
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05805956
- Sponsor's protocol ID
- IMM2902-001
- Status last verified
- Mar 2023
- First submitted
- 23 Mar 2023
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, First-in-human Dose-escalation and Cohort Expansion Phase I/II Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of IMM2902 in the Treatment of HER2-expressing Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05805956
- Acronym / sponsor ID
- IMM2902-001
- Conditions
- Advanced Solid Tumor, Advanced Lung Cancer, Advanced Gastric Carcinoma, Advanced Cholangiocarcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- ImmuneOnco Biopharmaceuticals (Shanghai) Inc.University, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 10 Apr 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 trial is an open-label, multicenter, first-in-human dose-escalation and cohort expansion Phase I/II clinical study to evaluate the safety, tolerability and preliminary efficacy of IMM2902 in the treatment of HER2-expressing advanced solid tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMM2902 | Experimental | Drug: IMM2902Phase 1 is the dose escalation part, patients with HER2 expressing solid tumors will be enrolled in groups of different dose levels, to explore MTD, RP2D, safety, and preliminary efficacy of IMM2902. Phase 2 is the cohort expansion part, patients with HER2 overexpressing advanced solid tumors will be enrolled in three cohorts, to explore the safety and efficacy of IMM2902. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Voluntarily sign the Informed Consent Form (ICF) and follow the protocol requirements;
- Age ≥ 18 years old and ≤ 75 years old, regardless of gender;
- Expected survival time ≥ 12 weeks;
- HER2 expression:
- HER2 protein expression or HER2 gene amplification was found in primary or metastatic tumor tissue (IHC) or FISH.
Key exclusion criteria (24 listed)
- Received the last systemic or local anti-tumor therapy within 4 weeks before the first administration, including chemotherapy, immunotherapy, biological agents, etc.; received hormone anti-tumor therapy, small molecule targeted therapy within 2 weeks before the first administration; Palliative local treatment for non-target lesions within 2 weeks before the first administration; received non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, tumor necrosis factor, etc., not including IL-11 for the treatment of thrombocytopenia); Chinese herbal medicine or Chinese patent medicine with anti-tumor indications within 1 week before the first administration.
- Received therapeutic drugs targeting SIRPα/CD47 4 weeks before the first administration, such as CD47 antibody, SIRPα fusion protein, SIRPα antibody and SIRPγ fusion protein;
- Patients with primary central nervous system (CNS) malignant tumors or active CNS metastases who have failed local treatment (radiotherapy or surgery), but the following patients are allowed to enroll: a. Asymptomatic brain metastases; b. Clinical symptoms are stable (that is, there is no imaging progress 4 weeks before the first administration, and any neurological symptoms have returned to the baseline level), and corticosteroids and other treatments for brain metastases are not required for ≥4 weeks;
- Uncontrolled hypertension (systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90mmHg) or pulmonary hypertension or unstable angina pectoris; myocardial infarction or bypass or stent surgery within 6 months before administration; Chronic heart failure history of grade III-IV of NYHA criteria; clinically significant valvular disease; serious arrhythmia requiring treatment (except atrial fibrillation, paroxysmal supraventricular tachycardia), including male QTc ≥ 450ms, Female QTc≥470ms (calculated by Fridericia formula); cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 12 months before enrollment;
- History of arterial thrombosis, deep vein thrombosis and pulmonary embolism within 3 months before the first administration;
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 |
|---|---|---|
| IMM2902a recombinant bispecific monoclonal antibody with high affinity to the dual targets, HER2 and CD47 | Drug | IMM2902 |
Primary outcome
maximum tolerated dose (MTD) of IMM2902
Time frame: 48 weeks
Observe the safety and tolerability of IMM2902 in patients with advanced solid tumors expressing human epidermal growth factor receptor 2 (HER2), so as to determine the MTD
recommended phase 2 dose (RP2D) of IMM2902
Time frame: 48 weeks
Observe the safety and tolerability of IMM2902 in patients with advanced solid tumors expressing human epidermal growth factor receptor 2 (HER2), so as to determine the RP2D
Treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 48 weeks
To evaluate the safety of IMM2902
objective response rate
Time frame: 48 weeks
proportion of subjects whose tumors achieved CR and PR after treatment
disease control rate
Time frame: 48 weeks
the proportion of subjects whose tumors achieved CR, PR and SD after treatment
duration of response
Time frame: 48 weeks
the time from the beginning of recording an objective response to the first occurrence of tumor progression, or death from any cause
progression-free survival
Time frame: 48 weeks
the time from the start of treatment to tumor progression or death from any cause
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 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.
2 sites 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 IMM2902 in people with Advanced Solid Tumor and Advanced Lung Cancer, run by ImmuneOnco Biopharmaceuticals (Shanghai) Inc. at 2 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 22 inclusion and 24 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 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dinglu Chen (18616907141, dinglu.chen@immuneonco.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximum tolerated dose (MTD) of IMM2902 (time frame: 48 weeks). The study lists 7 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 10 Apr 2023.