This study is an open-label, single-arm, multicenter Phase I clinical trial consisting of a dose-escalation phase (Phase Ia) and a cohort-expansion phase (Phase Ib). Phase Ia (Dose Escalation) aims to evaluate the safety and tolerability of DCTY1102 Injection in patients with advanced solid tumors positive for KRAS G12D mutation and HLA-A\*11:01 genotype, observe potential dose-limiting toxicities (DLTs), determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D), characterize the pharmacokinetic (PK) profile of DCTY1102 following infusion, assess its in vivo proliferation and persistence, preliminarily evaluate therapeutic efficacy, and investigate immunogenicity. Phase Ib (Cohort Expansion) will be conducted after establishing MTD and/or RP2D in Phase Ia. This phase further evaluates the preliminary efficacy, safety, PK profile, and immunogenicity of DCTY1102 Injection in patients with KRAS G12D mutation-positive, HLA-A\*11:01 genotype tumors, including colorectal cancer, pancreatic cancer, or other malignancies. The study plans to establish 2-3 cohorts: Cohort 1: Colorectal cancer Cohort 2: Pancreatic cancer Cohort 3: Other tumor types Each cohort will enroll approximately 15-31 patients who will receive DCTY1102 infusion at the MTD and/or RP2D dose levels identified in Phase Ia.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
110
Dose escalation will follow the standard "3+3" design. Patients will receive a single infusion of DCTY1102 injection. Exploration of higher, lower, or intermediate dose levels may be considered based on emerging safety and tolerability data. Dose escalation will proceed sequentially.
First Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Evaluate the safety of DCTY1102 in subjiects with advanced solid tumors
Incidence of dose-limiting toxicities
Time frame: 28 days after infusion
Adverse events and Serious adverse events
Incidence of adverse events and serious adverse events by dose level
Time frame: up to 24 months post-infusion
Preliminary anti-tumor activity of DCTY1102 in subject with advanced solid tumors
Confirmed ORR per RECIST V1.1,defined as the proportion of subjects with a confirmed PR or better best response
Time frame: Up to 24 months post-infusion
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