NCT07079228

Brief Summary

The goal of this study is to evaluate the efficacy of QLS31905 in combination with chemotherapy (nab-paclitaxel plus gemcitabine \[AG\]) versus placebo in combination with chemotherapy (AG) in the treatment of CLDN18.2-positive advanced pancreatic cancer in adult participants.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
602

participants targeted

Target at P75+ for phase_3 pancreatic-cancer

Timeline
52mo left

Started Sep 2025

Typical duration for phase_3 pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Sep 2025Sep 2030

First Submitted

Initial submission to the registry

July 13, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 22, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

September 8, 2025

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2030

Last Updated

September 23, 2025

Status Verified

July 1, 2025

Enrollment Period

3.2 years

First QC Date

July 13, 2025

Last Update Submit

September 18, 2025

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall Suryival(OS)

    OS is defined as the time from randomization to deathdue to any cause.

    Up to 48 months

Secondary Outcomes (4)

  • Progression Free Survival (PFS)

    Up to 48 months

  • Objective Response Rate (ORR)

    Up to 48 months

  • Duration Of Response (DOR)

    Up to 48 months

  • Safety assessed by Adverse Events (AEs)

    Up to 48 months

Study Arms (2)

QLS31905 + nab-paclitaxel + gemcitabine (AG)

EXPERIMENTAL
Drug: QLS31905Drug: Nab-paclitaxel.Drug: Gemcitabine

Placebo + nab-paclitaxel + gemcitabine (AG)

ACTIVE COMPARATOR
Drug: Placebo for QLS31905Drug: Nab-paclitaxel.Drug: Gemcitabine

Interventions

QLS31905DRUG

QLS31905 will be administered as an IV infusion.

QLS31905 + nab-paclitaxel + gemcitabine (AG)
Nab-paclitaxel.DRUG

Nab-paclitaxel will be administered as an IV infusion.

QLS31905 + nab-paclitaxel + gemcitabine (AG)
GemcitabineDRUG

Gemcitabine will be administered as an IV infusion.

QLS31905 + nab-paclitaxel + gemcitabine (AG)
Placebo for QLS31905DRUG

Placebo will be administered as an IV infusion.

Placebo + nab-paclitaxel + gemcitabine (AG)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects voluntarily participate in the study and sign the informed consent form;
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
  • Expected survival time ≥ 3 months;
  • Histologically or cytologically confirmed diagnosis of pancreatic cancer;
  • No prior systemic anti-tumor treatment for unresectable locally advanced or metastatic disease;
  • At least one measurable lesion per RECIST v1.1;
  • Patients with adequate cardiac, liver, renal function, etc.

You may not qualify if:

  • History of malignancies other than the target cancer within 5 years prior to the first dose of the investigational product ;
  • Underwent major organ surgery (excluding needle biopsy) or had significant trauma within 28 days prior to enrollment, or requires elective surgery during the study;
  • Known central nervous system metastases;
  • Patients with hepatitis B; patients with hepatitis C; patients who test positive for syphilis, or patients with a known history of HIV or positive HIV screening test;
  • Patients with added risks associated with the study or may interfere with the interpretation of study results as determined by the investigator, or deemed unsuitable by the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Cancer Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

130-nm albumin-bound paclitaxelGemcitabine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Central Study Contacts

Lin Shen, M.D

CONTACT

010-88196561linshenpku@163.com

Jihui Hao, M.D

CONTACT

022-23340123-3070haojihui@tjmuch.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2025

First Posted

July 22, 2025

Study Start

September 8, 2025

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

September 1, 2030

Last Updated

September 23, 2025

Record last verified: 2025-07

Locations

CN(1)