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A Phase I/IIa Study of GKL-006 Injection in Patients With Advanced Pancreatic Cancer

NCT07777211 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2026-08-20

No results posted yet for this study

Summary

This is a Phase I/IIa, multicenter study designed to evaluate the safety, tolerability, and efficacy of GKL-006 injection in patients with ductal adenocarcinoma of pancreas.

Conditions

Interventions

BIOLOGICAL

GKL-006 injection

GKL-006 injection will be administered at the protocol-defined dose every 2 weeks. Participants in Phase I will receive the assigned low or high dose, and recommended dose in Phase II.

DRUG

Nab-paclitaxel and Gemcitabine

Nab-paclitaxel and Gemcitabine are given intravenously as a combination chemotherapy regimen according to the study protocol.

Sponsors & Collaborators

  • Beijing Gene Key Life Technology Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-14
Primary Completion
2027-03-31
Completion
2027-08-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07777211 on ClinicalTrials.gov