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Epithelial Cancer PatientsPhase 1/2IMC001 EpCAMNCT07644403

Phase I/IIa Clinical Trial of IMC001 in Patients With Advanced Epithelial Solid Tumors.

A Phase 1/2 study testing Autologous CAR-T cell injection targeting EpCAM in people with Epithelial Cancer Patients, run by Suzhou Immunofoco Biotechnology Co., Ltd at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

This is an open -label phase I /IIa study designed to evaluate the safety and efficacy of IMC001 in patients with advanced epithelial solid tumors. The study comprises two parts: a phase I dose-escalation phase and a phase IIa phase to further explore and validate efficacy .In the Phase I dose-escalation phase of this… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Epithelial Cancer Patients
What is being tested?
Autologous CAR-T cell injection targeting EpCAM
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
5 Mar 2026to 31 Dec 2027
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

  • to provide a signed and dated informed consent form before conducting any research-related procedures , and willing and able to comply with all research procedures.
  • Applicants must be 18 years of age or older and 75 years of age or younger; both male and female applicants are welcome .
  • Subjects with histologically or cytologically confirmed locally advanced/metastatic epithelial solid tumors , including but not limited to subjects with advanced gastric cancer/gastroesophageal junction adenocarcinoma, triple-negative breast cancer, biliary tract tumors, ovarian cancer, colorectal cancer, pancreatic cancer, gastrointestinal and pancreatic neuroendocrine tumors, etc.
  • Disease progression or intolerance to standard systemic therapy , including:
  • Gastric cancer and gastroesophageal junction adenocarcinoma that have failed or are intolerant of at least two lines of standard systemic therapy. If first-line three-drug combination therapy has failed or is intolerant, enrollment may be made after thorough investigator evaluation.
  • Triple-negative breast cancer: Subjects with unresectable locally advanced or metastatic triple-negative breast cancer who have failed at least two lines of standard systemic therapy. All subjects must have previously received taxane therapy, regardless of the stage of disease at the time of treatment.
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  • Other subjects with epithelial solid tumors who have failed or are intolerant of standard treatment.
  • Tumor tissue samples (primary or metastatic, archived or newly collected) from the expected subjects, tested by the central laboratory, are EpCAM histologically positive (defined as tumor cell positivity ≥10% and staining intensity ≥1+).
  • The expected survival period of the subjects is ≥12 weeks .
  • According to RECIST 1.1 criteria, there should be at least one stably measurable target lesion (where the largest lesion should be ≤4). In the 3×10⁵ CAR -T cells/kg dose group, subjects with evaluable lesions (unmeasurable lesions) can be admitted.
  • ECOG performance status score 0-1 .
  • The subject has adequate organ and bone marrow function. Laboratory screening must meet the following criteria: all laboratory test results should be within the stable ranges outlined below, and there should be no ongoing supportive treatment. If any laboratory test result is abnormal according to the following criteria, a repeat test may be performed within one week. If the test results still do not meet the following criteria, the subject's screening has failed.
  • Blood tests [No intensive blood transfusions (≥2 times within 1 week), platelet transfusions, or cell growth factor injections (excluding recombinant erythropoietin)) within 7 days prior to the test]: Neutrophil count (ANC) ≥1.5×10⁹ / L; Platelet count (PLT) ≥100 × 10⁹ / L; Hemoglobin content (Hb) ≥9.0g / dL; Lymphocyte count ( ALC ) ≥0.5× 10⁹ /L ;
  • Liver function: alanine aminotransferase (ALT) ≤ 2.5 × ULN, aspartate aminotransferase (AST) ≤ 2.5 × ULN, serum total bilirubin (TB) ≤ 2 × ULN; for subjects with liver metastases, AST and ALT < 5 × ULN ;
  • Kidney function: Serum creatinine ≤1.5×ULN; if serum creatinine >1.5×ULN, creatinine clearance rate >50mL/min is required (according to the Cockcroft-Gault formula); qualitative urine protein ≤1+; if qualitative urine protein ≥2+, a 24-hour urine protein quantification test is required (if the 24-hour urine protein quantification test is <1g, it is acceptable).
  • Amylase and lipase ≤1.5×ULN; alkaline phosphatase (ALP) ≤2.5×ULN, and for subjects with bone metastases, ALP <5×ULN ;
  • Coagulation function: Activated partial thromboplastin time ≤ 1.5 ULN, prothrombin time ≤ 1.5 × ULN ;
  • All toxicities resulting from prior antitumor therapy were reduced to grade 0-1 (according to NCI CTCAE version 5.0) or to a level acceptable to the inclusion criteria. Other toxicities, such as alopecia and vitiligo, which the investigators deemed not to pose a safety risk to the subjects, were excluded .
  • Reproductive status: Female subjects of reproductive age or male subjects whose sexual partners are women of reproductive age, who are willing to use medically approved and highly effective contraceptive methods, such as intrauterine devices or condoms, from the time they sign the informed consent form until 12 months after cell infusion (women of reproductive age include premenopausal women and women within 24 months after menopause) .

Who cannot join

  • Pregnant and breastfeeding women .
  • Positive for human immunodeficiency virus (HIV) antibodies; hepatitis B virus infection ( if the subject is positive for hepatitis B surface antigen, regardless of whether the core antibody is negative or positive, they can also be enrolled if the viral DNA load is negative, and prophylactic antiviral treatment should be considered ); acute or chronic active hepatitis C (positive for HCV antibodies); positive for syphilis antibodies; Epstein-Barr virus (EBV) infection ( positive for IgM or known EBV infection ); cytomegalovirus (CMV) infection (positive for IgM); positive for human T-lymphotropic virus (HTLV). The results of the above pathogen tests are subject to the results of the central laboratory .
  • Severe infections that are in an active phase or poorly controlled clinically .
  • The patients had uncontrollable pleural effusion, pericardial effusion, and ascites before enrollment .
  • Extensive or diffuse lung metastases , extensive or diffuse liver metastases , extensive or diffuse bone metastases .
  • Subjects with intestinal obstruction or obstructive jaundice who are deemed unsuitable for participation in this trial by the researchers .
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  • Blood oxygen saturation ≤95% without oxygen supplementation .
  • Patients with other serious lung 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 abnormalities in pulmonary function tests .
  • Subjects with a known history or current hepatic encephalopathy requiring treatment; subjects with a current or history of central nervous system disorders, such as seizures, cerebral ischemia/hemorrhagic disease, dementia, cerebellar disease, or any autoimmune disease involving the central nervous system .
  • Central nervous system metastasis or meningeal metastasis .
  • Currently, patients have unstable heart disease requiring treatment or heart disease that cannot be controlled by treatment, or hypertension that is poorly controlled according to investigators (defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure >100 mmHg after standard antihypertensive drug treatment); or diabetes that is poorly controlled despite standard treatment (fasting blood glucose ≥10.2 mmol/L) .
  • If any of the following cardiac clinical symptoms or conditions exist within 6 months prior to cell infusion:
  • Left ventricular ejection fraction (LVEF) < 50%;
  • History of myocardial infarction within the past year; or unstable angina; or percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG); or use of a pacemaker;
  • Resting electrocardiogram examination: QTc F > 450ms (male) or QTc F > 470ms (female);
  • An electrocardiogram at rest reveals clinically significant abnormalities (such as abnormalities in heart rate, conduction, or morphological characteristics) or complete left bundle branch block or third-degree atrioventricular block or a PR interval >250 ms.
  • Evidence of a significant coagulation disorder or other obvious risk of bleeding, including:
  • Abnormal coagulation function that is clinically significant;
  • History of intracranial hemorrhage or spinal cord hemorrhage;
  • Patients with tumor lesions invading major blood vessels and posing a significant risk of bleeding;
  • Subjects who currently have unstable or active ulcers or active gastrointestinal bleeding;
  • An embolic event occurred within 6 months prior to cell reinfusion;
  • Within one month prior to cell reinfusion, there has been clinically significant hemoptysis or obvious bleeding from tumor lesions;
  • Had a major trauma or major surgery within one month prior to enrollment;
  • The presence of any bleeding disorder, such as hemophilia, von Willebrand disease, etc.;
  • The patient has received anticoagulation therapy (excluding low molecular weight heparin) for therapeutic purposes within 2 weeks prior to cell reinfusion.
  • Subjects are receiving routine anticoagulation therapy (such as warfarin or heparin). Subjects require long-term antiplatelet therapy (aspirin >300 mg/day; clopidogrel >75 mg/day); dipyridamole, ticlopidine, or cilostazol, etc.
  • The patient has received systemic steroids equivalent to >15 mg/day of prednisone for more than 3 days within 2 weeks prior to apheresis, excluding inhaled steroids .
  • Subjects requiring systemic therapy with corticosteroids or other immunosuppressive drugs during treatment. Subjects with any active autoimmune disease, or a history of autoimmune disease with anticipated relapse (including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, and asthma requiring medical intervention with bronchodilators). Exceptions include: type 1 diabetes; skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis); alopecia; hypothyroidism requiring only hormone replacement therapy; asthma that was completely remitted in childhood and requires no intervention in adulthood; or other conditions not expected to relapse in the absence of external triggers .
  • Subjects with a prior or concurrent history of other malignant tumors, except in the following circumstances:
  • Basal cell or squamous cell carcinoma that has undergone adequate treatment (sufficient wound healing is required before enrollment in the study).
  • Cervical cancer or breast cancer in situ, cured and with no signs of recurrence for at least 3 years prior to the study;
  • The primary malignant tumor has been completely removed and has been in complete remission for ≥5 years ; d ) The concurrent malignant tumor was an epithelial tumor that expressed EpCAM .
  • Subjects who have previously received other gene therapies, including but not limited to CAR-T therapy and TCR-T therapy .
  • The following treatments or medications were received before cell reinfusion: chemotherapy, targeted therapy, biotherapy, endocrine therapy, immunotherapy, or other anti-tumor treatments (excluding treatments that meet the protocol requirements before reinfusion, such as lymph node pretreatment and bridging therapy); less than 28 days or less than 5 half-lives since the first infusion treatment in this study (whichever is shorter); or traditional Chinese medicine treatment with anti-tumor indications received within 2 weeks before cell reinfusion .
  • of severe allergies, such as anaphylactic shock .
  • Subjects with severe mental disorders .
  • Subjects who develop new cardiac arrhythmias, including but not limited to arrhythmias that cannot be controlled by medication; hypotension requiring vasopressors; or bacterial, fungal, or viral infections requiring intravenous antibiotics. Subjects receiving antibiotics to prevent infection may continue to participate in the trial at the investigator's discretion .
  • The patient had participated in other interventional clinical studies and used investigational drugs within one month prior to the planned infusion of IMC001 .
  • Subjects who received a live attenuated vaccine within 4 weeks prior to the planned single-donor administration or who are scheduled to receive a live attenuated vaccine during the study.
  • Subjects with any other concurrent serious and /or uncontrolled medical conditions that the investigators deem unsuitable for participation in this trial.
  • Researchers assessed that participants were unable or unwilling to comply with the requirements of the research protocol .

Trial locations and contacts

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

China1 site

  • Beijing Cancer Hospital

    Beijing

Other trials in China

About this study

Official title: Phase I/IIa Clinical Trial Evaluating the Safety and Efficacy of IMC001 in Patients With Advanced Epithelial Solid Tumors.

This is an open -label phase I /IIa study designed to evaluate the safety and efficacy of IMC001 in patients with advanced epithelial solid tumors. The study comprises two parts: a phase I dose-escalation phase and a phase IIa phase to further explore and validate efficacy .In the Phase I dose-escalation phase of this study, approximately 7-15 subjects with advanced epithelial solid tumors will be recruited to evaluate the safety and tolerability of autologous IMC001 treatment . In the expansion phase, at least two dose groups will be selected , each recruiting 5-10 subjects. Combined with the subjects from the escalation phase, each dose group will be expanded to approximately 10 subjects to determine the recommended RP2D dose for progression to Phase IIa . DLT ( digestive tract aging) assessment will be performed on subjects in each cohort within 28 days of IMC001 infusion . the RP2D is determined , approximately 6-20 subjects will be initially enrolled at this dose for each selected tumor type to further explore the efficacy and safety of autologous IMC001 for this indication. Subsequently, the protocol may be revised based on statistical hypotheses and regulatory requirements to continue enrolling subjects in the selected tumor types to further validate the efficacy and safety in specific tumor types.the date on which the last participant completes a two-year follow-up visit, is lost to follow up, withdraws informed consent, or dies (whichever occurs first) . It is important to note that for long-term follow-up programs such as ADA, RCL, and VIS (up to 15 years), which require protocol-based follow-up, these follow-ups will be conducted continuously according to protocol and regulatory requirements. However, the actual study participation time for each participant will vary depending on screening requirements, response to treatment, long-term follow-up arrangements, and survival status .

Being tested
Autologous CAR-T cell injection targeting EpCAM

What participants receive

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

  • Autologous CAR-T cell injection targeting EpCAMDrug

    In the Phase I dose-escalation phase of this study, approximately 7-15 subjects with advanced epithelial solid tumors will be recruited to evaluate the safety and tolerability of autologous IMC001 treatment. DLT (digestive-thickness assessment) will be performed on subjects in each cohort within 28 days after IMC001 infusion; the definition of DLT is detailed below. The expansion phase will select at least two dose groups, each recruiting 5-10 subjects (in conjunction with the escalation phase, expanding each dose group to approximately 10 subjects), to determine the recommended RP2D dose for progression to Phase IIa.

Study groups in NCT07644403
Study groupRoleWhat they receive
Each subject will be infused once with autologous CAR-T cell injection targeting EpCAMExperimentalNot described
Receives: Drug: Autologous CAR-T cell injection targeting EpCAM

What is being measured

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

  1. Observe dose limiting toxicity (DLTs) of IMC001 within 28 days after administration according to the DLT definition in the protocol

    White blood cells (10 ^ 9/L), red blood cells (10 ^ 12/L), platelet count (10 ^ 9/L), hemoglobin (g/L), treatment-related lymphohistiocytosis (HLH)/hemophagocytic lymphohistiocytosis (HPS), cytokine release syndrome (CRS), immune cell therapy related neurotoxicity syndrome (ICANS)

    Measured: Within 28 days after administration of IMC001

  2. After treatment with IMC001, the recommended Phase II dose (RP2D) is determined based on dose limiting toxicity (DLT) and clinical response, including potential side effects

    According to the results of the Safety Monitoring Committee (SMC) meeting, 2-3 dose levels will be selected for expansion, with an additional 5 to 10 subjects (excluding dose escalation subjects) to further evaluate safety and initial efficacy, and determine the recommended dose for entering Phase IIa (RP2D).

    Measured: Complete the incremental and expansion phases for all dose groups, and have the Safety Monitoring Committee (SMC) further evaluate safety and initial efficacy, and determine the recommended dose for entering Phase IIa (RP2D).

  3. Evaluate the objective response rate (ORR) of tumors based on RECIST 1.1

    According to RECIST 1.1, the number of people who have achieved complete remission (CR) and partial remission (PR) is evaluated

    Measured: According to the study protocol, periodic imaging assessments will be conducted at scheduled visits until the confirmed PD, 2 years (96 weeks) after infusion, loss to follow-up, withdrawal of informed consent, or death (whichever occurs first)

Secondary outcomes (4)

  1. Pharmacokinetic evaluation (regarding Cmax)

    Maximum concentration of CAR-T cells in peripheral blood after administration (CAR+cells/μL blood)

    Measured: From IMC001 infusion until 96 weeks.

  2. Pharmacokinetic evaluation (regarding Tmax)

    Time to reach maximum concentration (Days)

    Measured: From IMC001 infusion until 96 weeks.

  3. Pharmacokinetic evaluation (approximately AUC0-28d)

    The area under the CAR-T concentration time curve within 28 days after IMC001 infusion

    Measured: From IMC001 infusion to 28 days after infusion

  4. Pharmacodynamic evaluation

    The concentration levels of CAR-T related serum cytokines such as CRP, IL-6, and INF - γ at each time point

    Measured: Collect data from IMC001 infusion (day -1, day 0, day 1, day 3, day 7, day 9, day 14, day 21, day 28) until disease progression or peak monitoring occurs, if CAR copy number, death, or other cause is not detected for two consecutive episodes (whichever o

Timeline

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

  1. First posted12 Jun 2026
  2. Study start5 Mar 2026
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07644403
Sponsor's protocol ID
IMC001-RT02
Acronym
IMC001 EpCAM
Status last verified
Jun 2026
First submitted
20 Jan 2026
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Autologous CAR-T cell injection targeting EpCAM in people with Epithelial Cancer Patients, run by Suzhou Immunofoco Biotechnology Co., Ltd at 1 site 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 19 inclusion and 42 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: enrolling by invitation, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

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?

Observe dose limiting toxicity (DLTs) of IMC001 within 28 days after administration according to the DLT definition in the protocol (time frame: Within 28 days after administration of IMC001). The study lists 3 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 NCT07644403.

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 12 Jun 2026.

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