TumorPhase 1NCT05549557
IMM40H Phase I Dose Escalation and Expansion
A Phase 1 study testing IMM40H in people with Tumor, run by ImmuneOnco Biopharmaceuticals (Shanghai) Inc..
Trial summary
This is first-in-human, open-label, multi-center, dose-escalation (phase Ia) and cohort expansion (phase Ib) phase I study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamic, immunogenicity, and antitumor activities of IMM40H in patients with advanced malignancies including solid tumor and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumor
- What is being tested?
- IMM40H
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Sep 2022to Jun 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 old; no gender limitation;
- Expected survival time ≥12 weeks;
- ECOG score is 0 - 1 points;
- The interval between the first dose of previous anti-tumor therapy and the first dose must meet the following conditions:
- 1)Subjects who have received chemical drugs, small molecule targeted therapy drugs, immunomodulators or Chinese patent medicines with clear anti-tumor indications in the past should discontinue the drug for at least 2 weeks or 5 half-lives, whichever is shorter; 2)Subjects who have received macromolecular targeted drugs and protein preparations in the past should discontinue the drug for 5 half-lives or 4 weeks, whichever is shorter; 3)Subjects who have previously received radiotherapy, cell transplantation, CAR-T or immune checkpoint inhibitors such as PD-1/PD-L1 therapy should discontinue the drug for at least 4 weeks; 5. Subjects who have suitable organ function and hematopoietic function:
- Neutrophil count ≥1.0 × 109/L; (no short-acting drugs for leucopenia within 1 week; no long-acting drugs for leucopenia within 3 weeks, such as granulocyte colony-stimulating factor);
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- Platelet count ≥75 × 109/L (without bone marrow infiltration) / ≥50 × 109/L (with bone marrow infiltration); (have not received platelet transfusion therapy within 1 week);
- Hemoglobin ≥80 g/L (without bone marrow infiltration) / ≥70 g/L (with bone marrow infiltration); (have not received red blood cell transfusion therapy or biological response modifiers such as erythropoietin within 2 weeks);
- Total bilirubin (TBIL) ≤ 1.5 × ULN; TBIL ≤ 3 × ULN if there is liver metastasis;
- Both aspartate aminotransferase (AST) and alanine aminotransferase (ALT) should be ≤2.5×ULN; if there is liver metastasis, both AST and ALT should be ≤5.0×ULN;
- International normalized ratio (INR) ≤ 2 × ULN, or activated partial thromboplastin time (APTT) ≤ 2.0 × ULN;
- Heart: left ventricular ejection fraction (LVEF) ≥ 50%;
- Creatinine clearance (CrCl) ≥30 mL/min/1.73m2 or serum creatinine (Cr) ≤1.5 × ULN; 6. Subjects who have AEs related to previous systemic chemotherapy, radical/extensive radiotherapy or other anti-tumor drug treatment recovered to (NCI CTCAE v5.0) ≤ grade 1 (except for alopecia, skin hyperpigmentation, skin induration, skin atrophy, which are not clinically significant or those with no clinical significance in the opinion of the investigator); 7. Men and women of childbearing age should agree to take effective contraceptive measures such as barrier contraception, hormonal contraception or long-term use of contraceptives from the time of signing the informed consent to 3 months after the last dose.
- 8. Subjects should voluntarily sign the informed consent form, understand the study and be willing to follow the protocol requirements and have the ability to complete all experimental procedures.
- 9. Subjects' diseases can be assessed.
Who cannot join
- 1. Subjects have received CD70-targeted therapy in the past; 2. Subjects who have received allogeneic transplantation in the past and require continuous use of immunosuppressive agents; 3. Patients who have primary central nervous system (CNS) malignant tumor or patients with active CNS metastases who have failed local treatment (radiotherapy or surgery), but the following patients are allowed to be enrolled: a. asymptomatic brain metastases; b. clinically stable (i.e. no imaging progression was seen 4 weeks before the first dose, and any neurological symptoms had returned to baseline levels) and no treatment for brain metastases was required; 4. Subjects who have serious organic disease, or the investigator judges that it is not suitable to participate in the study due to the combination of other serious diseases:
- Have hypertension, pulmonary hypertension, or unstable angina that is difficult to control with medication;
- Have myocardial infarction or bypass or stent surgery within 6 months before administration;
- History of chronic heart failure with New York Heart Association (NYHA) criteria 3-4 within 6 months prior to administration;
- Have serious arrhythmias requiring treatment (excluding atrial fibrillation, polymorphic ventricular tachycardia), including QTc ≥450ms for men and ≥470ms for women (calculated by Fridericia formula);
- Have cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 12 months before enrollment;
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- History of arterial thrombosis, deep vein thrombosis and pulmonary embolism within 3 months before administration;
- History of moderate or severe dyspnea at rest, or current need for continuous oxygen therapy, or current interstitial lung disease (ILD) or pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm;
- Presence of a disorder that may cause gastrointestinal bleeding or perforation (e.g. symptomatic duodenal ulcer requiring treatment, intestinal obstruction, acute or chronic Crohn's disease, ulcerative colitis, or those with a history of intestinal perforation and intestinal fistula who have not been cured);
- The puncture and drainage treatment cannot control the disease and repeated drainage is required or there is pleural, abdominal or pericardial effusion with obvious symptoms; 5. Subjects who have active viral hepatitis B (HBsAg positive and/or HBcAb positive, and HBV DNA ≥1000 IU/mL), or active viral hepatitis C (anti-HCV antibody positive, and HCV RNA higher than the lower limit), or who are HIV-infected.
- 6. Subjects who have active autoimmune disorders and need to rely on immunosuppressive therapy or receive systemic hormone therapy with a dose of ≥10 mg/day of prednisone or other equivalent hormones within 2 weeks before enrollment; 7. Subjects who have uncontrollable serious active infection (such as sepsis, bacteremia, viremia, etc.); 8. Subjects who have received live attenuated vaccine within 4 weeks before the first administration; 9. Subjects who have major surgery within 4 weeks before the first administration or plan to take major surgery within 3 months after the first administration of the study drug, excluding intubation, peripheral venipuncture, central venous catheterization, etc.; 10. Subjects who have a history of neurological or mental disorders and have been hospitalized within the past six months, and have a history of alcohol and drug abuse within the past year; 11. Women with positive serum pregnancy test or during the lactation period; 12. Men and women of childbearing age are unwilling to take adequate contraceptive measures during the study period and within 3 months after the last dose; 13. Other circumstances that the investigator considers inappropriate to participate in this study.
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About this study
Official title: An Open-label, Multi-center Phase I Clinical Study of IMM40H in Patients With Advanced Solid Tumor and Hematological Malignancies
This is first-in-human, open-label, multi-center, dose-escalation (phase Ia) and cohort expansion (phase Ib) phase I study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamic, immunogenicity, and antitumor activities of IMM40H in patients with advanced malignancies including solid tumor and hematological malignancies.
Read the detailed description
This study will include 16~27 patients with advanced malignancies that have progressed after or have no response to previous standard treatments or for whom no standard treatments are available (including but not limited to melanoma, nasopharyngeal cancer, thymoma, RCC, colorectal cancer, non-small cell lung cancer (NSCLC), glioblastoma, astrocytoma, ovarian cancer, AML, and lymphoma). The primary objective is to determine the maximum tolerated dosage (MTD) or recommended dose for expansion (RDE) by observing the safety and tolerability of IMM40H monotherapy.
The adjusted "3 + 3" design will be adopted in this trial for dose escalation, with the starting dose of IMM40H at 0.3 mg/kg and the temporary maximum dose at 20 mg/kg. In the dose-escalation stage, a total of 5 dose levels will be designed:0.3, 1, 3, 10, 20 mg/kg, to determine MTD . For each subject in each dose group, the dose will be gradually increased according to the dose-escalation rules, and the observation period for dose-limiting toxicity (DLT) will be set to be 28 days after the first dose.
Patients with CD70-positive malignancies to further evaluate the safety, PK characteristics, immunogenicity, and anti-tumor activity or preliminary efficacy of IMM40H dosing at MTD.
- Conditions
- Tumor
- Being tested
- IMM40H
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMM40HDrug
Also called study drug: IMM40H
IMM40H is a monoclonal antibody with a molecular generated from ImmuneOnco's antibody platform. IMM40H targets CD70 (a tumor cell marker).
| Study group | Role | What they receive |
|---|---|---|
| IMM40H | Experimental | IMM40H is a monoclonal antibody with target CD70. Receives: Drug: IMM40H |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of IMM40H in patients with advanced malignancies.
DLT
Measured: 28 days
Secondary outcomes (5)
To evaluate the maximum observed plasma concentration (Cmax) of IMM40H in patients with advanced malignancies;
maximum observed plasma concentration (Cmax) characteristics
Measured: 6 months
To evaluate the time at which Cmax occurred (Tmax) of IMM40H in patients with advanced malignancies;
the time at which Cmax occurred (Tmax) characteristics
Measured: 6 months
To evaluate the area under the plasma drug concentration-time curve from time 0 to the last quantifiable time point (AUC0-t) of IMM40H in patients with advanced malignancies;
the area under the plasma drug concentration-time curve from time 0 to the last quantifiable time point (AUC0-t) characteristics
Measured: 6 months
To evaluate the area under the plasma drug concentration-time curve from time 0 extrapolated to infinity (AUC0-∞) of IMM40H in patients with advanced malignancies;
the area under the plasma drug concentration-time curve from time 0 extrapolated to infinity (AUC0-∞) characteristics
Measured: 6 months
To evaluate the terminal half-life (t1/2) of IMM40H in patients with advanced malignancies;
the terminal half-life (t1/2) characteristics
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study startSep 2022 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 16 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
- NCT05549557
- Sponsor's protocol ID
- IMM40H-01
- Status last verified
- Sep 2022
- First submitted
- 15 Sep 2022
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center Phase I Clinical Study of IMM40H in Patients With Advanced Solid Tumor and Hematological Malignancies
- ClinicalTrials.gov ID
- NCT05549557
- Acronym / sponsor ID
- IMM40H-01
- Conditions
- Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- ImmuneOnco Biopharmaceuticals (Shanghai) Inc.University, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 22 Sep 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.
This is first-in-human, open-label, multi-center, dose-escalation (phase Ia) and cohort expansion (phase Ib) phase I study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamic, immunogenicity, and antitumor activities of IMM40H in patients with advanced malignancies including solid tumor and hematological malignancies.
Detailed description
This study will include 16~27 patients with advanced malignancies that have progressed after or have no response to previous standard treatments or for whom no standard treatments are available (including but not limited to melanoma, nasopharyngeal cancer, thymoma, RCC, colorectal cancer, non-small cell lung cancer (NSCLC), glioblastoma, astrocytoma, ovarian cancer, AML, and lymphoma). The primary objective is to determine the maximum tolerated dosage (MTD) or recommended dose for expansion (RDE) by observing the safety and tolerability of IMM40H monotherapy.
The adjusted "3 + 3" design will be adopted in this trial for dose escalation, with the starting dose of IMM40H at 0.3 mg/kg and the temporary maximum dose at 20 mg/kg. In the dose-escalation stage, a total of 5 dose levels will be designed:0.3, 1, 3, 10, 20 mg/kg, to determine MTD . For each subject in each dose group, the dose will be gradually increased according to the dose-escalation rules, and the observation period for dose-limiting toxicity (DLT) will be set to be 28 days after the first dose.
Patients with CD70-positive malignancies to further evaluate the safety, PK characteristics, immunogenicity, and anti-tumor activity or preliminary efficacy of IMM40H dosing at MTD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMM40H | Experimental | Drug: IMM40HIMM40H is a monoclonal antibody with target CD70. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age ≥ 18 years old; no gender limitation;
- Expected survival time ≥12 weeks;
- ECOG score is 0 - 1 points;
- The interval between the first dose of previous anti-tumor therapy and the first dose must meet the following conditions:
- 1)Subjects who have received chemical drugs, small molecule targeted therapy drugs, immunomodulators or Chinese patent medicines with clear anti-tumor indications in the past should discontinue the drug for at least 2 weeks or 5 half-lives, whichever is shorter; 2)Subjects who have received macromolecular targeted drugs and protein preparations in the past should discontinue the drug for 5 half-lives or 4 weeks, whichever is shorter; 3)Subjects who have previously received radiotherapy, cell transplantation, CAR-T or immune checkpoint inhibitors such as PD-1/PD-L1 therapy should discontinue the drug for at least 4 weeks; 5. Subjects who have suitable organ function and hematopoietic function:
Key exclusion criteria (12 listed)
- 1. Subjects have received CD70-targeted therapy in the past; 2. Subjects who have received allogeneic transplantation in the past and require continuous use of immunosuppressive agents; 3. Patients who have primary central nervous system (CNS) malignant tumor or patients with active CNS metastases who have failed local treatment (radiotherapy or surgery), but the following patients are allowed to be enrolled: a. asymptomatic brain metastases; b. clinically stable (i.e. no imaging progression was seen 4 weeks before the first dose, and any neurological symptoms had returned to baseline levels) and no treatment for brain metastases was required; 4. Subjects who have serious organic disease, or the investigator judges that it is not suitable to participate in the study due to the combination of other serious diseases:
- Have hypertension, pulmonary hypertension, or unstable angina that is difficult to control with medication;
- Have myocardial infarction or bypass or stent surgery within 6 months before administration;
- History of chronic heart failure with New York Heart Association (NYHA) criteria 3-4 within 6 months prior to administration;
- Have serious arrhythmias requiring treatment (excluding atrial fibrillation, polymorphic ventricular tachycardia), including QTc ≥450ms for men and ≥470ms for women (calculated by Fridericia formula);
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 |
|---|---|---|
| IMM40HAlso: study drug: IMM40HIMM40H is a monoclonal antibody with a molecular generated from ImmuneOnco's antibody platform. IMM40H targets CD70 (a tumor cell marker). | Drug | IMM40H |
Primary outcome
To evaluate the safety and tolerability of IMM40H in patients with advanced malignancies.
Time frame: 28 days
DLT
5 secondary outcomes
To evaluate the maximum observed plasma concentration (Cmax) of IMM40H in patients with advanced malignancies;
Time frame: 6 months
To evaluate the time at which Cmax occurred (Tmax) of IMM40H in patients with advanced malignancies;
Time frame: 6 months
To evaluate the area under the plasma drug concentration-time curve from time 0 to the last quantifiable time point (AUC0-t) of IMM40H in patients with advanced malignancies;
Time frame: 6 months
To evaluate the area under the plasma drug concentration-time curve from time 0 extrapolated to infinity (AUC0-∞) of IMM40H in patients with advanced malignancies;
Time frame: 6 months
To evaluate the terminal half-life (t1/2) of IMM40H in patients with advanced malignancies;
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IMM40H in people with Tumor, run by ImmuneOnco Biopharmaceuticals (Shanghai) Inc..
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 15 inclusion and 12 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 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
To evaluate the safety and tolerability of IMM40H in patients with advanced malignancies. (time frame: 28 days). 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 22 Sep 2022.