A Study of DCTY1102 Injection in Patients With Advanced Solid Tumors

Launched by BEIJING DCTY BIOTECH CO.,LTD. · Jun 3, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called DCTY1102 Injection for patients with advanced solid tumors, specifically those with certain types of cancer like pancreatic cancer, colorectal cancer, and non-small cell lung cancer. The trial is divided into two phases. The first phase focuses on finding out how safe the treatment is and what the best dose would be, while the second phase will look more closely at how effective the treatment is after the safe dose is determined. Participants in the trial will receive the DCTY1102 injection, and the researchers will monitor their health and response to the treatment.

To join the trial, patients need to be between 18 and 75 years old and have advanced cancers that have not responded to standard treatments. They must have specific genetic markers related to their tumors, and they should have measurable signs of their cancer. Patients who are pregnant, breastfeeding, or have certain health issues may not be eligible. If someone joins the trial, they can expect to receive the DCTY1102 injection and have regular check-ups to assess their health and how well the treatment is working. This trial is still in the planning stages and has not started recruiting participants yet.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Informed consent:Written informed consent form (ICF) must be signed prior to any study-related procedures (including pre-screening and main screening).
• • Age:18 ≤ Age ≤ 75 years
• • Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors, who have experienced failure of standard treatment (disease progression after treatment or intolerable toxic side effects), have no standard treatment available, for whom standard treatment is not applicable at present, or who refuse standard treatment.
• • Have at least one measurable lesion (according to RECIST v1.1).
• • The prescreening must meet the following two criteria simultaneously: HLA-A 11:01 genotype, and not carrying the HLA-A 68:01 subtype; Positive for the tumor KRAS G12D mutation.
• • ECOG 0-2 with life expectancy ≥3 months.
• • LVEF ≥50% by echocardiography
• • SpO₂ ≥92% on room air
• • Laboratory Parameters: ANC ≥1.5×10⁹/L, ALC ≥0.7×10⁹/L, Platelets ≥75×10⁹/L, Hemoglobin ≥85 g/L, TBIL ≤1.5×ULN, ALT/AST ≤2.5×ULN, Cr ≤1.5×ULN, Ccr ≥50 mL/min, APTT ≤1.5×ULN, INR ≤1.5×ULN
• • Child-Pugh Class A or favorable B (score ≤7)
• • For patients with advanced primary hepatocellular carcinoma, Child-Pugh liver function classification must be Class A or relatively well-preserved Class B (score ≤7).
• • Pre-menopausal fertile women who have not undergone sterilization surgery must agree to use effective contraception from the start of lymphodepleting chemotherapy until one year after cell infusion, and have a negative serum pregnancy test within 14 days before cell infusion
• • Men who have not undergone sterilization surgery must agree to use effective contraception from the start of lymphodepleting chemotherapy until one year after cell infusion.
• Exclusion Criteria:
• • Received last dose of anti - tumor therapy (chemotherapy, endocrine therapy, targeted therapy, immunotherapy, tumor embolization, or traditional Chinese medicine with anti - tumor indications, etc.) within 4 weeks before lymphodepleting chemotherapy.
• • Received live - attenuated vaccine within 4 weeks before apheresis.
• • Previously received any genetically engineered T - cell therapy or therapy targeting KRAS G12D mutation.
• • Known allergy to any component of the study treatment.
• • Not recovered from adverse events of previous surgery or therapy to ≤Grade 1 CTCAE v5.0 (excluding any - grade alopecia, ≤Grade 2 peripheral sensory neuropathy, and toxicities deemed safe by the investigator).
• • History of leptomeningeal or central nervous system (CNS) metastases, or definite CNS disease within 6 months before cell infusion with residual symptoms. Asymptomatic brain metastases or stable symptoms after treatment (surgery/radiation) without steroid use are allowed.
• • Poorly controlled hypertension (systolic BP\>160 mmHg and/or diastolic BP\>100 mmHg) or clinically significant cardiovascular disease (e.g., stroke, myocardial infarction within 6 months before signing the consent form, unstable angina, NYHA Class Ⅱ or higher heart failure, or severe arrhythmia not controlled by medication or potentially impacting study treatment). ECG shows clinically significant abnormalities in 3 consecutive readings (at least 5 - min intervals) or average QTcF≥450ms.
• • Have other severe organic or psychiatric diseases.
• • Have systemic active infection requiring IV antibiotics.
• • Known HIV infection (anti - HIV antibody - positive), active hepatitis B (HBsAg - positive or HBcAb - positive with HBV - DNA - positive), active hepatitis C (anti - HCV antibody - positive with HCV - RNA - positive), or syphilis infection (anti - TP - positive).
• • Diagnosed with severe autoimmune disease requiring long - term (over 2 months) systemic immunosuppressants (steroids) or immune - mediated symptomatic disease (e.g., ulcerative colitis, Crohn's disease, rheumatoid arthritis, SLE, autoimmune vasculitis like Wegener's granulomatosis).
• • Used systemic steroids (inhaled or topical use excluded), hydroxyurea, immunomodulators (e.g., α/γ - interferons, GM - CSF, mTOR inhibitors, cyclosporine, thymopeptide, etc.) within 2 weeks before apheresis or plan to use during the study.
• • History of allogeneic organ transplantation, allogeneic stem cell transplantation, and renal replacement therapy.
• • Uncontrolled diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease, or hepatic failure
• • Known alcohol and/or drug abuse.
• • Pregnant or breastfeeding women.
• • Have any concurrent medical condition or disease that the investigator considers may affect the trial.
• • Patients without legal capacity or with limited legal capacity.
• • Investigator deems the patient unable to complete all study visits/procedures (including follow - up) or has insufficient adherence, or considers the patient unsuitable for inclusion.