Advanced Solid TumorPhase 1NCT05076591
IMM2902, a HER2/SIRPα Bispecific MAb-Trap Antibody-receptor Fusion Protein, in Patients with HER2-expressing Advanced Solid Tumors
A Phase 1 study testing IMM2902 in people with Advanced Solid Tumor and Advanced Breast Cancer, run by ImmuneOnco Biopharmaceuticals (Shanghai) Inc. at 3 sites in United States.
Trial summary
This trial is a first-in-human, open label, multi-center, dose escalation phase 1a study followed by a disease-specific dose expansion phase 1b study to evaluate the safety, efficacy, and pharmacokinetics (PK) of IMM2902, a HER2/SIRPα bispecific mAb-Trap antibody-receptor fusion protein, in patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Advanced Breast Cancer, Advanced Gastric Cancer
- What is being tested?
- IMM2902
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Jun 2022to Dec 2024
- 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
- Age ≥ 18 years
- Weigh greater than 30 kg
- life expectancy of at least 3 months
- Phase 1a Histologically or cytologically confirmed HER2-expressing advanced solid malignancy, who have been treated with at least one regimen of prior systemic therapy, or who refuse systemic therapy, and for which there is no curative therapy available.
- Phase 1b Histological Diagnsis There will be 5 cohorts:
- Cohort 1: Histologically confirmed HER2 overexpression (HER2 IHC 3+ or HER2 IHC 2+/ISH-positive) locally advanced (unresectable) and/or metastatic breast cancer who have progression on or after at least 2 prior lines of anti-HER2 directed therapy with trastuzumab, pertuzumab, tucatinib, Fam-trastuzumab deruxtecan-nxki and T-DM1 or other anti-HER2 therapy.
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- Cohort 2: Histologically confirmed HER2-low (HER2 IHC 1+ or HER2 IHC 2+/ISH-negative and/or HER2 gene amplification in tumor specimen or in circulating tumor cells by ISH, NGS, or ctDNA-NGS) locally advanced (unresectable) and/or metastatic breast cancer who have progression after 2 or more lines of systemic therapy.
- Cohort 3: Histologically confirmed HER2 overexpression (HER2 IHC 3+ or HER2 IHC 2+/ISH-positive) locally advanced (unresectable) and/or metastatic gastric/esophageal/gastroesophageal junction (GEJ) cancer who have progression on or after at least one prior therapy, including prior fluoropyrimidine + platinum and prior trastuzumab, and/or fam-trastuzumab deruxtecan-nxki or other prior anti-HER2 (including investigational) therapy.
- Cohort 4: Histologically confirmed HER2-low (HER2 IHC 1+ or HER2 IHC 2+/ISH-negative and/or HER2 gene amplification in tumor specimen or in circulating tumor cells by ISH, NGS, or ctDNA-NGS) locally advanced (unresectable) and/or metastatic gastric/esophageal/gastroesophageal junction (GEJ) cancer who have progression after 2 or more lines of systemic therapy.
- Cohort 5: Histologically confirmed HER2 overexpression (HER2 IHC 3+ or HER2 IHC 2+/ISH-positive) any other solid tumor types, including but not limited to colorectal cancer, non-small cell lung (NSCLC), ovarian cancers, that are not breast
- Has at least non-irradiated evaluable disease (target or non-target lesions) per RECIST version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
- Completion of prior chemotherapy systemic anticancer therapy at least 2 weeks prior to study entry.
- Radiation therapy must be completed at least 2 weeks prior to study entry. Radiated lesions may not serve as measurable disease unless they have been radiated ≥12 months prior to enrollment.
- Patients may have parenchymal brain metastases if stable (no evidence of progression) for at least 1 month after local therapy (radiation or surgery). Leptomeningeal disease is excluded.
- Patients must have adequate organ and bone marrow function within 14 days of first dose of study drug administration
- Female subject must either be of non-reproductive potential or must have a negative urine or serum prenancy test within 7 days prior to the first dose of IMM2902.
Who cannot join
- Prior anti-cancer therapy including chemotherapy, hormonal therapy, or investigational agents within 2 weeks or within at least 4 half-lives prior to IMM2902 dosing (up to a maximum of 4 weeks).
- Prior treatment with neoadjuvant or adjuvant anthracyclines within cumulative dose of doxorubicin of >400 mg/m2 or epirubicin of >800 mg/m².
- Prior treatment with CD47 or SIRPα-targeting agents.
- Trastuzumab, pertuzumab, lapatinib, tucatinib, fam-trastuzumab deruxtecan-nxki or T-DM1 within 3 weeks before first IMM2902 dosing.
- Any unresolved toxicity NCI CTCAE v5.0 Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.
- Mean QT interval corrected for heart rate (QTc) ≥ 450 ms for males or QTc ≥ 470 ms for females calculated from 2 electrocardiograms (ECGs) using Fridericia's formula. Two EKGs 5 minutes (+/-2 min) apart are mandatory.
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- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]).
- Symptomatic congestive heart failure New York Heart Association (NYHA) Function Classification II-IV, uncontrolled hypertension, acute myocardial infarction within the last 6 months, unstable angina pectoris, cardiac arrhythmia.
- Uncontrolled diabetes mellitus, Interstitial lung disease, serious gastrointestinal conditions associated with diarrhea.
- Pulmonary embolism or deep vein thrombosis within 3 months prior to the first dose of study drug.
- Uncontrolled pulmonary, renal, or hepatic dysfunction.
- Ongoing or active infection requiring systemic treatment.
- Psychiatric illness/social situations that would limit compliance with study requirements, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
- Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints.
- Second malignancy, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer, or other malignancy for which treatment was completed at least 3 years ago and for which there is no evidence of recurrence.
- Known allergic reactions to any component or excipient of IMM2902 or known allergic reactions to trastuzumab or other prior anti-HER2 (including investigational) or other monoclonal antibody ≥ Grade 3.
- Patients requiring concomitant therapeutic anticoagulation, excluding those taking low dose of anticoagulation agents for diseases such as pulmonary embolism, deep venous thrombosis.
- Known active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus.
- Known inherited or acquired bleeding disorders.
- History of hemolytic anemia or Evans syndrome, sickle cell disease, thalassemia, G6PD deficiency, hereditary spherocytosis, or hypersplenism in the last 3 months.
- Current or prior use of immunosuppressive therapy within 14 days before the first dose of IMM2902.
- Receipt of live attenuated vaccination within 30 days prior to registration.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02215
Mary Crowley Cancer Research
Dallas, Texas, 75251
NEXT Virginia, LLC
Fairfax, Virginia, 22031
About this study
Official title: A Phase 1, Open-Label, Multicenter, Dose Escalation Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of IMM2902 in Patients with HER2-Expressing Advanced Solid Tumors
This trial is a first-in-human, open label, multi-center, dose escalation phase 1a study followed by a disease-specific dose expansion phase 1b study to evaluate the safety, efficacy, and pharmacokinetics (PK) of IMM2902, a HER2/SIRPα bispecific mAb-Trap antibody-receptor fusion protein, in patients with HER2-expressing advanced solid tumor.
- 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 | IMM2902 Phase 1a Dose escalation: 0.03, 0.1, 0.25, 0.5, 1.0, 1.5, and 2.0 mg/kg through intravenous administration weekly up to 48 weeks.
Phase 1b Dose expansion: A disease-specific dose expansion study in patients with locally advanced (unresectable) and/or metastatic breast with HER2-overexpression (Cohort 1) or HER2-low (Cohort 2), gastric/esophageal/gastroesophageal junction (GEJ) cancer with HER2-overexpression (Cohort 3) or HER2-low (Cohort 4) and other solid tumors with HER2-overexpression (Cohort 5) is aimed at further defining safety and characterizing efficacy. Dose expansion is through intravenous administration weekly up to 48 weeks. Receives: Drug: IMM2902 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicity (DLT)
All toxicities will be graded according to the NCI CTCAE Version 5.0, which provides additional guidance for AEs not specifically mentioned in CTCAE. A DLTs is defined as any Grade 3 or greater AE that is assessed as related to study treatment that occurs during the 4-week DLTs observation period.
Measured: 48 Weeks
maximum tolerated dose (MTD) of IMM2902
Toxicity will be evaluated according to the NCI CTCAE Version 5.0.
Measured: 48 Weeks
dose for expansion (RDE) of IMM2902
Toxicity will be evaluated according to the NCI CTCAE Version 5.0.
Measured: 48 Weeks
Number of patients with Adverse Events（AEs）
Graded according to the NCI CTCAE V5.0
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 posted13 Oct 2021
- Study start20 Jun 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: Due to a business decision resulting in the deprioritization of this project and with no safety concerns present, we (the trial sponsor) have decided to request the discontinuation of study IMM2902-101.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cheng Huang, MD, Study director, VP，Clinical DevelopmentFrank Xiaodong Gan, Study director, SVP, Clinical Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05076591
- Sponsor's protocol ID
- IMM2902-101
- Status last verified
- Oct 2024
- First submitted
- 27 Sep 2021
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Multicenter, Dose Escalation Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of IMM2902 in Patients with HER2-Expressing Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05076591
- Acronym / sponsor ID
- IMM2902-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Due to a business decision resulting in the deprioritization of this project and with no safety concerns present, we (the trial sponsor) have decided to request the discontinuation of study IMM2902-101.
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- ImmuneOnco Biopharmaceuticals (Shanghai) Inc.University, hospital or other
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 13 Oct 2021 (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 a first-in-human, open label, multi-center, dose escalation phase 1a study followed by a disease-specific dose expansion phase 1b study to evaluate the safety, efficacy, and pharmacokinetics (PK) of IMM2902, a HER2/SIRPα bispecific mAb-Trap antibody-receptor fusion protein, in patients with HER2-expressing advanced solid tumor.
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: IMM2902IMM2902 Phase 1a Dose escalation: 0.03, 0.1, 0.25, 0.5, 1.0, 1.5, and 2.0 mg/kg through intravenous administration weekly up to 48 weeks. Phase 1b Dose expansion: A disease-specific dose expansion study in patients with locally advanced (unresectable) and/or metastatic breast with HER2-overexpression (Cohort 1) or HER2-low (Cohort 2), gastric/esophageal/gastroesophageal junction (GEJ) cancer with HER2-overexpression (Cohort 3) or HER2-low (Cohort 4) and other solid tumors with HER2-overexpression (Cohort 5) is aimed at further defining safety and characterizing efficacy. Dose expansion is through intravenous administration weekly up to 48 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age ≥ 18 years
- Weigh greater than 30 kg
- life expectancy of at least 3 months
- Phase 1a Histologically or cytologically confirmed HER2-expressing advanced solid malignancy, who have been treated with at least one regimen of prior systemic therapy, or who refuse systemic therapy, and for which there is no curative therapy available.
- Phase 1b Histological Diagnsis There will be 5 cohorts:
Key exclusion criteria (22 listed)
- Prior anti-cancer therapy including chemotherapy, hormonal therapy, or investigational agents within 2 weeks or within at least 4 half-lives prior to IMM2902 dosing (up to a maximum of 4 weeks).
- Prior treatment with neoadjuvant or adjuvant anthracyclines within cumulative dose of doxorubicin of >400 mg/m2 or epirubicin of >800 mg/m².
- Prior treatment with CD47 or SIRPα-targeting agents.
- Trastuzumab, pertuzumab, lapatinib, tucatinib, fam-trastuzumab deruxtecan-nxki or T-DM1 within 3 weeks before first IMM2902 dosing.
- Any unresolved toxicity NCI CTCAE v5.0 Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.
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
Dose-Limiting Toxicity (DLT)
Time frame: 48 Weeks
All toxicities will be graded according to the NCI CTCAE Version 5.0, which provides additional guidance for AEs not specifically mentioned in CTCAE. A DLTs is defined as any Grade 3 or greater AE that is assessed as related to study treatment that occurs during the 4-week DLTs observation period.
maximum tolerated dose (MTD) of IMM2902
Time frame: 48 Weeks
Toxicity will be evaluated according to the NCI CTCAE Version 5.0.
dose for expansion (RDE) of IMM2902
Time frame: 48 Weeks
Toxicity will be evaluated according to the NCI CTCAE Version 5.0.
Number of patients with Adverse Events（AEs）
Time frame: 48 Weeks
Graded according to the NCI CTCAE V5.0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Cheng Huang, MD study director
VP，Clinical Development
Frank Xiaodong Gan study director
SVP, Clinical Development
3 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 IMM2902 in people with Advanced Solid Tumor and Advanced Breast Cancer, run by ImmuneOnco Biopharmaceuticals (Shanghai) Inc. at 3 sites in United States.
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 17 inclusion and 22 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: paused, as of the sponsor's last update on 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-Limiting Toxicity (DLT) (time frame: 48 Weeks). 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?
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 30 Oct 2024.