NCT07014878

A Study of DCTY1102 Injection in Patients With Advanced Solid Tumors

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Beijing DCTY Biotech Co.,Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• PDAC
• CRC (Colorectal Cancer)
• NSCLC
• Solid Tumor Malignancies

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-06-01
• Primary completion: 2028-05-01
• Completion: 2028-05-01
• First posted: 2025-06-11
• Last updated: 2025-06-11

Locations

1 site across 1 country: China