Combination of QLS31905 and Chemotherapy ± QL2107 in Patients With CLDN18.2-positive Advanced Biliary Tract Cancer

Qilu Pharmaceutical

Status and phase: Not yet enrolling; Phase 2

Conditions: CLDN18.2-positive Advanced Biliary Tract Cancer

Treatments: Drug: Cisplatin for Injection; Drug: QLS31905 for Injection; Drug: QL2107 Injection; Drug: Capecitabine Tablets; Drug: Gemcitabine Hydrochloride for Injection; Drug: Oxaliplatin Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07151872

QLS31905-205

Details and patient eligibility

About

This is an open-label, multicenter Phase II clinical study aimed at evaluating the efficacy, safety, PK profile, and immunogenicity of QLS31905 for Injection combined with Chemotherapy ± QL2107 in Patients with CLDN18.2-positive Advanced Biliary Tract Cancer

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with unresectable locally advanced or metastatic Biliary Tract Cancer confirmed by histopathological or cytological examination;
• Subjects with at least one measurable lesion designated as a target lesion, as assessed by the investigator according to RECIST v1.1. Lesions that have received radiotherapy or other local treatments may be considered measurable if they demonstrate imaging PD;
• No prior systemic anti-tumor treatment for locally advanced or metastatic Biliary Tract Cancer.

Exclusion criteria

• Subjects with a known history of severe or repeated allergy, intolerance, or contraindication to QLS31905, QL2107, or other large molecule protein preparations, as well as Gemcitabine Hydrochloride for Injection, Cisplatin for Injection, Oxaliplatin Injection or Capecitabine Tablets and any components in their preparations;
• Subjects had other second primary malignancies within 5 years prior to the first dose;
• Subjects with clinically significant hemorrhage within 3 months before the first dose;

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

QLS31905 +GP

Experimental group

Treatment:

Drug: Gemcitabine Hydrochloride for Injection

Drug: QLS31905 for Injection

Drug: Cisplatin for Injection

QLS31905 +GP+QL2107

Experimental group

Treatment:

Drug: Gemcitabine Hydrochloride for Injection

Drug: QL2107 Injection

Drug: QLS31905 for Injection

Drug: Cisplatin for Injection

QLS31905 +XELOX

Experimental group

Treatment:

Drug: Oxaliplatin Injection

Drug: Capecitabine Tablets

Drug: QLS31905 for Injection