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

NCT07644403 | Enrolling By Invitation Phase 1

• 1 other identifier: IMC001-RT02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 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 .

Conditions

Epithelial Cancer Patients

Outcome Measures

Primary Outcomes (3)

• 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)

  Within 28 days after administration of IMC001

• 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).

  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).

• 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

  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)

• Pharmacokinetic evaluation (regarding Cmax)

  From IMC001 infusion until 96 weeks.

• Pharmacokinetic evaluation (regarding Tmax)

  From IMC001 infusion until 96 weeks.

• Pharmacokinetic evaluation (approximately AUC0-28d)

  From IMC001 infusion to 28 days after infusion

• Pharmacodynamic evaluation

  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

Other Outcomes (1)

• Replicative lentivirus (RCL)

  Baseline, 16 weeks, 48 weeks, until subject loss to follow-up, death, withdrawal of informed consent, cell transfusion for 2 years (96 weeks) or termination of the trial (whichever occurs first), with a maximum monitoring period of 15 years.

Study Arms (1)

Each subject will be infused once with autologous CAR-T cell injection targeting EpCAM

EXPERIMENTAL

Drug: Autologous CAR-T cell injection targeting EpCAM

Interventions

Autologous CAR-T cell injection targeting EpCAM DRUG

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.

Each subject will be infused once with autologous CAR-T cell injection targeting EpCAM

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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 .
• 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);

Sponsors & Collaborators

• Suzhou Immunofoco Biotechnology Co., Ltd: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: June 12, 2026
• Study Start: March 5, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)