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NOT YET RECRUITING
NCT07014878
PHASE1

A Study of DCTY1102 Injection in Patients With Advanced Solid Tumors

Sponsor: Beijing DCTY Biotech Co.,Ltd.

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of DCTY1102 Injection in Patients With Advanced Solid Tumors Positive for KRAS G12D Mutation and HLA-A*11:01 Genotype

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2025-06

Completion Date

2028-05

Last Updated

2025-06-11

Healthy Volunteers

No

Interventions

BIOLOGICAL

TCR-T cells

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.

Locations (1)

First Medical Center of Chinese PLA General Hospital

Beijing, Beijing Municipality, China