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

Qilu Pharmaceutical

Status and phase: Not yet enrolling; Phase 2

Conditions: Advanced Solid Tumor

Treatments: Drug: Cisplatin; Drug: Oxaliplatin; Drug: QLS31905; Drug: Chemotherapy drug; Drug: QL1706; Drug: Capecitabine; Drug: Gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT06446388

QLS31905-202

Details and patient eligibility

About

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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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360 participants in 9 patient groups

QLS31905 + oxaliplatin + capecitabine

Experimental group

Description:

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

Treatment:

Drug: Capecitabine

Drug: QLS31905

Drug: Oxaliplatin

QL1706 + oxaliplatin + capecitabine

Experimental group

Description:

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

Treatment:

Drug: QL1706

Drug: Capecitabine

Drug: Oxaliplatin

QLS31905 + oxaliplatin + capecitabine + QL1706

Experimental group

Description:

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.

Treatment:

Drug: QL1706

Drug: Capecitabine

Drug: QLS31905

Drug: Oxaliplatin

QLS31905 + gemcitabine+cisplatin

Experimental group

Description:

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

Treatment:

Drug: Gemcitabine

Drug: QLS31905

Drug: Cisplatin

QL1706 + gemcitabine+cisplatin

Experimental group

Description:

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

Treatment:

Drug: Gemcitabine

Drug: QL1706

Drug: Cisplatin

QLS31905 + gemcitabine+cisplatin+ QL1706

Experimental group

Description:

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

Treatment:

Drug: Gemcitabine

Drug: QL1706

Drug: QLS31905

Drug: Cisplatin

QLS31905 + standard chemotherapy

Experimental group

Description:

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.

Treatment:

Drug: Chemotherapy drug

Drug: QLS31905

QL1706 + standard chemotherapy

Experimental group

Description:

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

Treatment:

Drug: QL1706

Drug: Chemotherapy drug

QLS31905 + standard chemotherapy + QL1706

Experimental group

Description:

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

Treatment:

Drug: QL1706

Drug: Chemotherapy drug

Drug: QLS31905