Advanced Digestive System TumorPhase 1NCT05946226
A Phase I Trial to Evaluate the Safety of IMC002 in Advanced Digestive System Tumors
A Phase 1 study testing IMC002 injection in people with Advanced Digestive System Tumor, run by Suzhou Immunofoco Biotechnology Co., Ltd at 7 sites in China.
Trial summary
This is an open-label, multi-center, dose-escalation clinical study to evaluate the safety, feasibility, and preliminary efficacy of IMC002 in patients with CLDN18.2 positive digestive system tumors including but not limited to advanced gastric cancer, esophagogastric junction adenocarcinoma, and advanced pancreatic… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Digestive System Tumor
- What is being tested?
- IMC002 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 7 sitesChina
- Study dates
- 7 Sep 2023to 31 Dec 2025
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures
- Age > 18 and ≤70 years
- Patients with histologically or cytologically confirmed locally advanced/metastatic digestive system tumors including but not limited to advanced gastric cancer at least failed two lines of SOC, esophagogastric junction adenocarcinoma, and advanced pancreatic cancer failed at least one line SOC;
- Must have CLDN18.2 positive tumor expression histologically as determined by IHC (defined as positive rate of tumor cells≥40% and staining intensity ≥2+ ) or a biopsy if archived tumor sample is not available; representative tumor samples (primary or metastatic, archived or newly collected) are expected to be obtained
- Expected survival time ≥12 weeks
- Measurable or evaluable disease per RECIST1.1
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- ECOG performance status score of 0-1
- Adequate organ and bone marrow function. If any laboratory test results are abnormal with reference to the criteria below, a repeat test can be performed within 1 week. If the test results are still abnormal, the patient fails screening.
- Recovery to grade 0-1 from AEs related to prior anticancer therapy or to an acceptable level for inclusion/exclusion criteria except alopecia and vitiligo
- Female of childbearing age must undergo a serum pregnancy test with negative results at screening and infusion; Female of childbearing age or male patients whose sexual partners are females of childbearing age are willing to take medically approved high-efficiency contraceptive measures such as intrauterine devices or condoms from the time of signing the informed consent to 1 year after infusion (women of childbearing age include premenopausal women and women within 24 months of post menopause).
Who cannot join
- Pregnant and lactating women
- Human immunodeficiency virus (HIV) antibody positive; acute or chronic active hepatitis B; acute or chronic active hepatitis C Hepatitis. Syphilis antibody positive; cytomegalovirus (CMV) infection; Epstein-Barr (EB) virus infection.
- Active or clinically poorly controlled serious infections
- Uncontrollable pleural effusion, pericardial effusion and ascites effusion existed before enrollment.
- Extensive or diffuse lung or liver metastases
- Oxygen saturation ≤95% without oxygen inhalation
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- With other diseases that may limit their participation in this study, such as pulmonary embolism, chronic obstructive pulmonary disease, symptomatic or poorly controlled interstitial lung disease, or clinically significant abnormal lung function tests
- Known prior or current hepatic encephalopathy requiring treatment; patients with current or history of central nervous system (CNS) disease. Autoimmune diseases; CNS metastases or meningeal metastases with clinical symptoms, or other evidence that the patient's CNS or meningeal metastases have not been controlled, and are judged not suitable for the study by the investigator
- Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure > 100 mmHg after standardized antihypertensive drug treatment); not well controlled diabetes mellitus [fasting plasma glucose (FPG) ≥10.2mmol/L].
- Presence of any of clinical cardiac symptoms or disorders
- Evidence of major coagulopathy or other significant bleeding risk
- Systemic steroids equivalent to >15mg/day prednisone within 2 weeks before leukapheresis, except inhaled or topic steroids
- Requiring systemic therapy with corticosteroids or other immunosuppressive drugs during the treatment period. Presence of any active autoimmune disease, or history of autoimmune disease expect recur.
- Previous or concomitant other malignancies
- Have received other gene therapies including but not limited to any CAR-T and TCR-T therapy
- Anti-tumor therapies other than for the pretreatment and bridging therapies < 5 half-lives or 28 days (whichever is shorter) prior to study treatment
- Any investigational drugs or study drugs from a previous clinical study within 30 days prior to signing the informed consent; traditional Chinese medicine with anti-tumor activities within 2 weeks prior to the study treatment
- History of serious allergic disease or known allergy to any component of the study treatments
- With severe mental disorders
- Any issue that would impair the ability of the patient to receive or tolerate the planned treatment, to understand informed consent or any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality
Rongrui Liu
- Not yet recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan
Hongfeng Gou
- Not yet recruiting
Fujian Cancer Hospital
Fuzhou, Fujian
Jianwei Yang
- Not yet recruiting
First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Weijia Fang
- Not yet recruiting
Shandong Cancer Hospital
Jinan, Shandong
Zuoxing Niu
Yuping Sun
- Not yet recruiting
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
Yingbin Liu
- Not yet recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian
Jiayi Li
About this study
Official title: A Phase I, Open-label, Multi-center, Dose-escalation Study to Evaluate the Safety, Feasibility, and Preliminary Efficacy of IMC002 in Patients With Claudin18.2-positive Advanced Digestive System Tumors
This is an open-label, multi-center, dose-escalation clinical study to evaluate the safety, feasibility, and preliminary efficacy of IMC002 in patients with CLDN18.2 positive digestive system tumors including but not limited to advanced gastric cancer, esophagogastric junction adenocarcinoma, and advanced pancreatic cancer.
Read the detailed description
This is an open-label, multi-center, dose-escalation clinical study to evaluate the safety, feasibility, and preliminary efficacy of IMC002 in patients with CLDN18.2 positive digestive system tumors including but not limited to advanced gastric cancer, esophagogastric junction adenocarcinoma, and advanced pancreatic cancer.
Approximately 9-18 patients with CLDN18.2-positive advanced digestive system tumors will be sequentially enrolled into 3 dose escalation cohorts to evaluate the safety and feasibility of autologous IMC002 treatment. Following enrolment, patients will undergo leukapheresis and IMC002 product preparation. Patients may receive bridging therapies if the disease progresses rapidly as determined by the investigator. After treatment with cyclophosphamide, fludarabine and nab-paclitaxel lymphodepletion, patients will be assigned to one of three dose escalation cohorts 1.0×108, 2.5×108, or 5.0×108 CAR-T cells. All patients will be given a single dose of IMC002 infusion. All patients will be followed as inpatient for 14 days. When all patients of a cohort have been observed for 28 days and no DLT criteria have been met, patients will be enrolled in next higher dose cohort. All enrolled patients will follow the same study treatment schedule and procedural requirements.
This study is divided into a screening period, a lymphodepleting (LD) chemotherapy period, a treatment period, a primary follow-up period up to 12 weeks and a long-term follow-up period for up to 15 years post infusion.
- Conditions
- Advanced Digestive System Tumor
- Being tested
- IMC002 injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMC002 injectionBiological
Also called Autologous Claudin 18.2 specific CAR-T cell injection
three different IMC002 Doses will be escalated in "3+3" design
| Study group | Role | What they receive |
|---|---|---|
| IMC002 dose 1-3 | Experimental | IMC002 single infusion Receives: Biological: IMC002 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of dose-limiting toxicity (DLTs) within 28 days after IMC002 infusion
safety profile
Measured: within 28 days
Secondary outcomes (4)
ORR after IMC002 infusion
efficacy endpoints
Measured: upto 96 weeks
Incidences and severity of treatment-related adverse events (TRAEs)
AEs
Measured: upto 96 weeks
cytokine levels in the blood
IL-6, TNF-α, IL-10, IL-2, IFN-γ and other cytokines in peripheral
Measured: upto 96 weeks
CAR-positive cell counts in peripheral blood
Cmax
Measured: upto 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start7 Sep 2023
- Primary completion1 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Digestive System 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
- Sequential
- Model description
- A classic 3+3 model will be used to dose escalation 3 doses will be used: 1×10\^8, 2.5×10\^8 and 5×10\^8 CAR-T cells/ patients
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Immunofoco Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianming Xu, Pro., Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05946226
- Sponsor's protocol ID
- IMC002-RT01
- Status last verified
- Sep 2023
- First submitted
- 15 Jun 2023
- Last updated
- 28 Sep 2023
- 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 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Multi-center, Dose-escalation Study to Evaluate the Safety, Feasibility, and Preliminary Efficacy of IMC002 in Patients With Claudin18.2-positive Advanced Digestive System Tumors
- ClinicalTrials.gov ID
- NCT05946226
- Acronym / sponsor ID
- IMC002-RT01
- Conditions
- Advanced Digestive System Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Suzhou Immunofoco Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 7 Sep 2023 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 Jul 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 is an open-label, multi-center, dose-escalation clinical study to evaluate the safety, feasibility, and preliminary efficacy of IMC002 in patients with CLDN18.2 positive digestive system tumors including but not limited to advanced gastric cancer, esophagogastric junction adenocarcinoma, and advanced pancreatic cancer.
Detailed description
This is an open-label, multi-center, dose-escalation clinical study to evaluate the safety, feasibility, and preliminary efficacy of IMC002 in patients with CLDN18.2 positive digestive system tumors including but not limited to advanced gastric cancer, esophagogastric junction adenocarcinoma, and advanced pancreatic cancer.
Approximately 9-18 patients with CLDN18.2-positive advanced digestive system tumors will be sequentially enrolled into 3 dose escalation cohorts to evaluate the safety and feasibility of autologous IMC002 treatment. Following enrolment, patients will undergo leukapheresis and IMC002 product preparation. Patients may receive bridging therapies if the disease progresses rapidly as determined by the investigator. After treatment with cyclophosphamide, fludarabine and nab-paclitaxel lymphodepletion, patients will be assigned to one of three dose escalation cohorts 1.0×108, 2.5×108, or 5.0×108 CAR-T cells. All patients will be given a single dose of IMC002 infusion. All patients will be followed as inpatient for 14 days. When all patients of a cohort have been observed for 28 days and no DLT criteria have been met, patients will be enrolled in next higher dose cohort. All enrolled patients will follow the same study treatment schedule and procedural requirements.
This study is divided into a screening period, a lymphodepleting (LD) chemotherapy period, a treatment period, a primary follow-up period up to 12 weeks and a long-term follow-up period for up to 15 years post infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A classic 3+3 model will be used to dose escalation 3 doses will be used: 1×10^8, 2.5×10^8 and 5×10^8 CAR-T cells/ patients
| Arm | Type | Receives |
|---|---|---|
| IMC002 dose 1-3 | Experimental | Biological: IMC002 injectionIMC002 single infusion |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures
- Age > 18 and ≤70 years
- Patients with histologically or cytologically confirmed locally advanced/metastatic digestive system tumors including but not limited to advanced gastric cancer at least failed two lines of SOC, esophagogastric junction adenocarcinoma, and advanced pancreatic cancer failed at least one line SOC;
- Must have CLDN18.2 positive tumor expression histologically as determined by IHC (defined as positive rate of tumor cells≥40% and staining intensity ≥2+ ) or a biopsy if archived tumor sample is not available; representative tumor samples (primary or metastatic, archived or newly collected) are expected to be obtained
- Expected survival time ≥12 weeks
Key exclusion criteria (20 listed)
- Pregnant and lactating women
- Human immunodeficiency virus (HIV) antibody positive; acute or chronic active hepatitis B; acute or chronic active hepatitis C Hepatitis. Syphilis antibody positive; cytomegalovirus (CMV) infection; Epstein-Barr (EB) virus infection.
- Active or clinically poorly controlled serious infections
- Uncontrollable pleural effusion, pericardial effusion and ascites effusion existed before enrollment.
- Extensive or diffuse lung or liver metastases
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 |
|---|---|---|
| IMC002 injectionAlso: Autologous Claudin 18.2 specific CAR-T cell injectionthree different IMC002 Doses will be escalated in "3+3" design | Biological | IMC002 dose 1-3 |
Primary outcome
Incidence and severity of dose-limiting toxicity (DLTs) within 28 days after IMC002 infusion
Time frame: within 28 days
safety profile
4 secondary outcomes
ORR after IMC002 infusion
Time frame: upto 96 weeks
Incidences and severity of treatment-related adverse events (TRAEs)
Time frame: upto 96 weeks
cytokine levels in the blood
Time frame: upto 96 weeks
CAR-positive cell counts in peripheral blood
Time frame: upto 96 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- 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.
Jianming Xu, Pro. principal investigator
Chinese PLA General Hospital
7 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 IMC002 injection in people with Advanced Digestive System Tumor, run by Suzhou Immunofoco Biotechnology Co., Ltd at 7 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 20 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 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 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?
Contact Jianming Xu, Pro. (13910866712, jmxu2003@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of dose-limiting toxicity (DLTs) within 28 days after IMC002 infusion (time frame: within 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 28 Sep 2023.