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

NCT07777211 | Active Not Recruiting Phase 1

• 1 other identifier: GKL006PDA01
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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

Advanced Pancreatic Cancer; Ductal Adenocarcinoma of Pancreas

Keywords

GKL-006; iNKT cells

Outcome Measures

Primary Outcomes (2)

• Incidence of Dose-Limiting Toxicities

  The number and percentage of participants experiencing a dose-limiting toxicity during the protocol-defined DLT evaluation period. Dose-limiting toxicities will be assessed according to the criteria specified in the protocol.

  From the first dose until 42 days

• Incidence and Severity of Adverse Events and Serious Adverse Events

  The number and percentage of participants experiencing adverse events and serious adverse events, including their severity. The number and percentage of participants with clinically significant abnormalities in laboratory tests, 12-lead electrocardiograms, physical examinations, and vital signs.

  Up to 18 months

Secondary Outcomes (15)

• Progression-Free Survival

  Up to 18 months

• Objective Response Rate

  Up to 18 months

• Disease Control Rate

  Up to 18 months

• Duration of Response

  Up to 18 months

• Time to Progression

  Up to 18 months

Study Arms (4)

Phase I Low-Dose Cohort

EXPERIMENTAL

Low-Dose GKL-006 injection plus AG regimen

Biological: GKL-006 injection; Drug: Nab-paclitaxel and Gemcitabine

Phase I High-Dose Cohort

EXPERIMENTAL

High-Dose GKL-006 injection plus AG regimen

Biological: GKL-006 injection; Drug: Nab-paclitaxel and Gemcitabine

Phase II Investigational Arm

EXPERIMENTAL

Selected dose level of GKL-006 injection from phase I plus AG regimen

Biological: GKL-006 injection; Drug: Nab-paclitaxel and Gemcitabine

Phase II Control Arm

ACTIVE COMPARATOR

AG regimen, Nab-paclitaxel and gemcitabine per protocol

Drug: Nab-paclitaxel and Gemcitabine

Interventions

GKL-006 injection BIOLOGICAL

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.

Also known as: GKL-006

Phase I High-Dose Cohort; Phase I Low-Dose Cohort; Phase II Investigational Arm

Nab-paclitaxel and Gemcitabine DRUG

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

Also known as: nab-P+G, AG

Phase I High-Dose Cohort; Phase I Low-Dose Cohort; Phase II Control Arm; Phase II Investigational Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-75 years, inclusive, with no sex restriction.
• Histologically or cytologically confirmed unresectable locally advanced or metastatic PDAC.
• No prior systemic therapy for unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma. Prior neoadjuvant or adjuvant therapy will not be considered prior systemic therapy for advanced disease.
• For patients with postoperative recurrence or metastasis who previously received neoadjuvant or adjuvant therapy, disease progression or recurrence must have occurred at least 6 months after completion of prior therapy.
• At least one measurable lesion during screening, as defined by RECIST version 1.1.
• Able to understand and voluntarily sign the ICF, communicate adequately with the investigator, comply with study procedures and follow-up, and meet all study requirements.
• ECOG PS 0 or 1 and a life expectancy of at least 12 weeks.
• Adequate haematological and organ function, as demonstrated by protocol-specified laboratory values obtained within 14 days before enrolment or randomisation.
• No traditional Chinese medicine with an antitumour indication within 7 days before enrolment or randomisation.
• Participants of reproductive potential must use medically accepted contraception during study treatment and for 6 months after the end of treatment.

You may not qualify if:

• Known hypersensitivity to any component of the study treatments.
• Other unresolved malignancy within 5 years or concurrently, except specified adequately treated malignancies.
• Active, known, or suspected autoimmune disease, or systemic corticosteroid/immunosuppressive therapy within 4 weeks before screening.
• Major surgery or severe trauma within 6 months before screening, or planned major surgery during the study.
• Known brain or meningeal metastases, except stable brain metastases.
• Symptomatic ascites or pleural effusion.
• History or presence of clinically significant interstitial lung disease or active infection.
• Poorly controlled or clinically significant cardiovascular disease, including inadequately controlled hypertension within 7 days, unstable angina within 6 months, or acute myocardial infarction within 1 year before enrolment.
• Clinically significant proteinuria within 7 days before enrolment.
• Toxicity from prior anticancer therapy not recovered to protocol-specified levels.
• Clinically significant bleeding within 4 weeks, GI bleeding within 6 months, major-vessel invasion with a high bleeding risk, a known bleeding/thrombotic disorder, or arterial/venous thromboembolism within 6 months before enrolment/randomisation.
• History or presence of tumour-related GI obstruction requiring treatment.
• Active systemic infection requiring treatment within 2 weeks, or unexplained fever or clinically significant leukocytosis within 7 days before enrolment.
• Congenital or acquired immunodeficiency, active syphilis or another serious active infection, or HBV/HCV infection with detectable viral load at screening.
• Any contraindication to IL-2.

Sponsors & Collaborators

• Beijing Gene Key Life Technology Co., Ltd: lead

Study Sites (1)

No. 1 Shuaifuyuan, Wangfujing, Dongcheng District

Beijing, Beijing Municipality, 100010, China

Location

MeSH Terms

Interventions

130-nm albumin-bound paclitaxel; Gemcitabine

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and investigators are not masked to treatment assignment. Tumour response assessments are performed by a blinded Independent Review Committee.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study consists of two sequential parts. In Phase I, participants will be enrolled sequentially into a low-dose cohort followed by a high-dose cohort. In Phase II, participants will be assigned in parallel to the investigational arm or the control arm.

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: August 20, 2026
• Study Start: August 14, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: August 20, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)