Study of QLS31905 and/or QL1706 Combination With Chemotherapy in the Advanced Malignant Solid Tumors

NCT06446388 | Not Yet Recruiting Phase 2

• 1 other identifier: QLS31905-202
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the efficacy and safety of QLS31905 and/or QL1706 plus chemotherapy in patients with Claudin18.2-positive advanced solid tumors.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR)

  Approximately 24 months

Secondary Outcomes (12)

• Safety assessed by Adverse Events (AEs)

  Approximately 24 months

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

  Approximately 24 months

• Number of participants with laboratory value abnormalities

  Approximately 24 months

• Duration of Response (DOR)

  Approximately 24 months

• Progression Free Survival(PFS)

  Approximately 24 months

Study Arms (9)

QLS31905 + oxaliplatin + capecitabine

EXPERIMENTAL

Gastric/gastroesophageal junction cancer participants will be treated with QLS31905 at doses determined by the phase I study in combination with oxaliplatin and capecitabine.

Drug: QLS31905; Drug: Oxaliplatin; Drug: Capecitabine

QL1706 + oxaliplatin + capecitabine

EXPERIMENTAL

Gastric/gastroesophageal junction cancer participants will be treated with QL1706 in combination with oxaliplatin and capecitabine.

Drug: Oxaliplatin; Drug: Capecitabine; Drug: QL1706

QLS31905 + oxaliplatin + capecitabine + QL1706

EXPERIMENTAL

Gastric/gastroesophageal junction cancer participants will be treated with QLS31905 at doses determined by the phase I study in combination with oxaliplatin and capecitabine+ QL1706.

Drug: QLS31905; Drug: Oxaliplatin; Drug: Capecitabine; Drug: QL1706

QLS31905 + gemcitabine+cisplatin

EXPERIMENTAL

Biliary tract cancer will be treated with QLS31905 at doses determined by the phase I study in combination with gemcitabine and cisplatin.

Drug: QLS31905; Drug: Gemcitabine; Drug: Cisplatin

QL1706 + gemcitabine+cisplatin

EXPERIMENTAL

Biliary tract cancer will be treated with QL1706 in combination with gemcitabine and cisplatin.

Drug: Gemcitabine; Drug: Cisplatin; Drug: QL1706

QLS31905 + gemcitabine+cisplatin+ QL1706

EXPERIMENTAL

Biliary tract cancer will be treated with QLS31905 at doses determined by the phase I study in combination with gemcitabine and cisplatin+ QL1706.

Drug: QLS31905; Drug: Gemcitabine; Drug: Cisplatin; Drug: QL1706

QLS31905 + standard chemotherapy

EXPERIMENTAL

Other solid tumor participants will be treated with QLS31905 at doses determined by the phase I study in combination with standard chemotherapy recommended by guidelines.

Drug: QLS31905; Drug: Chemotherapy drug

QL1706 + standard chemotherapy

EXPERIMENTAL

Other solid tumor participants will be treated with QL1706 in combination with standard chemotherapy recommended by guidelines.

Drug: QL1706; Drug: Chemotherapy drug

QLS31905 + standard chemotherapy + QL1706

EXPERIMENTAL

Other solid tumor participants will be treated with QLS31905 at doses determined by the phase I study in combination with standard chemotherapy and QL1706.

Drug: QLS31905; Drug: QL1706; Drug: Chemotherapy drug

Interventions

QLS31905 DRUG

Administered as an intravenous infusion.

QLS31905 + gemcitabine+cisplatin; QLS31905 + gemcitabine+cisplatin+ QL1706; QLS31905 + oxaliplatin + capecitabine; QLS31905 + oxaliplatin + capecitabine + QL1706; QLS31905 + standard chemotherapy; QLS31905 + standard chemotherapy + QL1706

Oxaliplatin DRUG

130 mg/m2, intravenous infusion, D1, up to 8 cycles.

QL1706 + oxaliplatin + capecitabine; QLS31905 + oxaliplatin + capecitabine; QLS31905 + oxaliplatin + capecitabine + QL1706

Capecitabine DRUG

1000 mg/m2, oral, bid, D1-D14

QL1706 + oxaliplatin + capecitabine; QLS31905 + oxaliplatin + capecitabine; QLS31905 + oxaliplatin + capecitabine + QL1706

Gemcitabine DRUG

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

QL1706 + gemcitabine+cisplatin; QLS31905 + gemcitabine+cisplatin; QLS31905 + gemcitabine+cisplatin+ QL1706

Cisplatin DRUG

25 mg/m2, intravenous infusion, D1/D8, up to 8 cycles.

QL1706 + gemcitabine+cisplatin; QLS31905 + gemcitabine+cisplatin; QLS31905 + gemcitabine+cisplatin+ QL1706

QL1706 DRUG

5 mg/kg, intravenous infusion,D1

QL1706 + gemcitabine+cisplatin; QL1706 + oxaliplatin + capecitabine; QL1706 + standard chemotherapy; QLS31905 + gemcitabine+cisplatin+ QL1706; QLS31905 + oxaliplatin + capecitabine + QL1706; QLS31905 + standard chemotherapy + QL1706

Chemotherapy drug DRUG

Standard chemotherapy recommended by guidelines.

QL1706 + standard chemotherapy; QLS31905 + standard chemotherapy; QLS31905 + standard chemotherapy + QL1706

Eligibility Criteria

• Age: 18 Years - 75 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 be positive for Claudin18.2 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

Oxaliplatin; Capecitabine; Gemcitabine; Cisplatin

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2024
• First Posted: June 6, 2024
• Study Start: June 30, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 6, 2024

Record last verified: 2024-05

Locations

CN (1)