A Study of QLS31905 Combination Chemotherapy as First-Line Treatment in Patients With Advanced Solid Tumors

NCT06041035 | Unknown Phase 1

• 1 other identifier: QLS31905-201
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the efficacy and safety of QLS31905 plus chemotherapy in patients with Claudin18.2-positive advanced solid tumors.

Conditions

Solid Tumor

Keywords

CLDN18.2; QLS31905

Outcome Measures

Primary Outcomes (3)

• Maximum Tolerated Dose (MTD) (Part A)

  As measured by number of participants experiencing dose related toxicity (DLT) in each escalating cohort.

  Approximately 12 months

• Phase 2 Recommended Dose（RP2D)(Part A)

  Monitor for MTD, and minimal efficacious dose by monitoring responses at different dose levels.

  Approximately 12 months

• Objective response rate (ORR)(Part B)

  ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR) as assessed by investigator evaluation per RECIST 1.1.

  Approximately 12 months

Secondary Outcomes (12)

• Safety assessed by Adverse Events (AEs)

  Approximately 12 months

• Safety assessed by incidence of serious adverse events (SAE)

  Approximately 12 months

• Number of participants with laboratory value abnormalities and/or adverse events (AEs)

  Approximately 12 months

• Progression Free Survival(PFS)

  Approximately 12 months

• Duration Of Response (DOR)

  Approximately 12 months

Study Arms (3)

QLS31905 + nab-paclitaxel + gemcitabine (Part A/B)

EXPERIMENTAL

Pancreatic cancer participants will be treated with QLS31905 in combination with nab-paclitaxel and gemcitabine for part A of the study to establish the recommended dose of QLS31905 for part B. In part B, the participants will be treated with QLS31905 at a dose determined by the part A of the study in combination with nab-paclitaxel and gemcitabine.

Drug: QLS31905; Drug: Nab paclitaxel; Drug: Gemcitabine

QLS31905 + oxaliplatin + capecitabine (Part B)

EXPERIMENTAL

In part B, gastric/gastroesophageal junction cancer participants will be treated with QLS31905 at dose determined by part A of the study in combination with oxaliplatin and capecitabine.

Drug: QLS31905; Drug: Oxaliplatin; Drug: Capecitabine

QLS31905 + gemcitabine+cisplatin(Part B)

EXPERIMENTAL

In part B, other solid tumor participants including but not limited to biliary tract cancer will be treated with QLS31905 at dose determined by part A in combination with standard chemotherapy recommended by guidelines.QLS31905 plus gemcitabine+ cisplatin as the first-line treatment of advanced biliary tract cancer.

Drug: QLS31905; Drug: Gemcitabine; Drug: Cisplatin

Interventions

QLS31905 DRUG

Administered as an intravenous infusion.

QLS31905 + gemcitabine+cisplatin(Part B); QLS31905 + nab-paclitaxel + gemcitabine (Part A/B); QLS31905 + oxaliplatin + capecitabine (Part B)

Nab paclitaxel DRUG

125 mg/m2 administered as IV infusion on D1/D8/D15 of each cycle.

QLS31905 + nab-paclitaxel + gemcitabine (Part A/B)

Gemcitabine DRUG

1000 mg/m2 administered as IV infusion on D1/D8/D15 of each cycle.

QLS31905 + gemcitabine+cisplatin(Part B); QLS31905 + nab-paclitaxel + gemcitabine (Part A/B)

Oxaliplatin DRUG

85 mg/m2, intravenous infusion, D1/D15, up to 6 cycles.

QLS31905 + oxaliplatin + capecitabine (Part B)

Capecitabine DRUG

1000 mg/m2, oral, bid, D1-D7,D15-D21, up to 6 cycles.

QLS31905 + oxaliplatin + capecitabine (Part B)

Cisplatin DRUG

25 mg/m2, intravenous infusion, D1/D15, up to 6 cycles.

QLS31905 + gemcitabine+cisplatin(Part B)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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 locally advanced unresectable or metastatic solid tumors;
• No prior systemic anti-tumor treatment for locally advanced unresectable or metastatic disease;
• Tumor tissue samples determined to have moderate-to-high Claudin18.2 expression by immunohistochemistry (IHC);
• 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 a known history of psychoactive drug abuse, alcohol abuse, or substance abuse;
• 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 and/or sponsor.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Interventions

Taxes; Gemcitabine; Oxaliplatin; Capecitabine; Cisplatin

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Lin Shen, M.D

CONTACT

010-881965671; linshenpku@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: September 18, 2023
• Study Start: October 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2025
• Last Updated: September 18, 2023

Record last verified: 2023-09

Locations

CN (1)