QL1706 Plus Chemotherapy With AG Regime as First-line Treatment of Advanced PDAC

NCT06750861 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: NCC5035
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, open-label, exploratory study to evaluate the efficacy and safety of QL1706 plus nab-paclitaxel and gemcitabine as first-line treatment in patients with unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma.

Conditions

Pancreatic Adenocarcinoma

Keywords

QL1706; Efficacy; Pancreatic cancer; Safety; Chemotherapy; First-Line

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate (ORR)

  ORR of regimen of QL1706+AG

  1 year

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  The incidence and severity (graded by CTCAE 5.0) of treatment emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs), immune-related adverse events ( irAEs).

  1 year

Secondary Outcomes (4)

• Median Progression-Free Survival (mPFS)

  1 year

• Median Overall Survival (mOS)

  2 years

• Duration of Response (DoR)

  1 year

• Disease Control Rate (DCR)

  1 year

Study Arms (1)

QL1706+AG

EXPERIMENTAL

QL1706+AG Every 3 weeks as a cycle: QL1706: 5mg/kg, IV, D3; Q3W Nab-paclitaxel: 125mg/m2, IV，D1、8; Q3W Gemcitabine: 1000mg/m2，IV，D1、8; Q3W Re-evaluate patients every two cycles. If the patient has been treated for more than 8 cycles, they will enter maintenance therapy, and the regimen is QL1706 monotherapy.

Drug: QL1706

Interventions

QL1706 DRUG

QL1706+AG

QL1706+AG

Eligibility Criteria

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

You may qualify if:

• Age ≥18, male or female;
• Has histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC);
• Has not received prior systemic treatment for their locally advanced or metastatic PDAC;
• Has presence of measurable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST 1.1);
• Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status;
• Has a life expectancy of at least 3 months;
• Has adequate organ function;
• If female of childbearing potential, have a negative serum pregnancy test within 7 days prior to first trial treatment;
• If female of childbearing potential or a male subject with a partner with childbearing potential, be willing to use a highly effective method of contraception (with a failure rate of less than 1.0% per year) from first study treatment to 24 weeks after completion of the trial treatment.

You may not qualify if:

• Untreated active CNS metastasis or leptomeningeal metastasis.
• Is currently participating and receiving an investigational drug or has participated in a study of an investigational drug within 4 weeks or within 5 times of half-life (no less than 2 weeks), whichever is shorter prior to the first dose of trial treatment;
• Has received other anti-tumor treatment within 4 weeks or within 5 times of half-life (no less than 2 weeks), whichever is shorter prior to the first trial treatment;
• Major surgery for any reason, except diagnostic biopsy, within 4 weeks of the first administration of trial treatment and/or if the subject has not fully recovered from the surgery within 4 weeks of the first administration of trial treatment;
• Curative radiation within 3 months of the first dose of trial treatment. Radiation to more than 30% of the bone marrow or with a wide field of radiation should not be used within 4 weeks prior to the first administration of trial treatment;
• Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of trial treatment (with the exception of subjects with adrenal insufficiency, who may continue corticosteroids at physiologic replacement doses, equivalent to \< 10 mg prednisone daily, inhaled steroids and topical use of steroids);
• Vaccination within 28 days of the first administration of trial treatment, except for administration of inactivated vaccines (e.g., inactivated influenza vaccines);
• Has interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management;
• History or current active autoimmune disease that might deteriorate when receiving an immunostimulatory agent；
• Previous malignant disease History of uncontrolled intercurrent illness Prior therapy with any antibody/drug targeting T cell coregulatory proteins Known severe hypersensitivity reactions to antibody drug；
• Is pregnant or breastfeeding;
• Other medical conditions that at the discretion of investigator interfere with the requirements of the trial in terms of safety or efficacy evaluation, or treatment compliance.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Chaoyang District, 100021, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Lin Yang, Doctor

CONTACT

13681015148; linyangcicams@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 27, 2024
• Study Start: February 15, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)