A Study of QLP2117 in Combination With QL2107 in Advanced Solid Tumor Patients

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorQilu Pharmaceutical Co., Ltd.

About this trial

The goal of this clinical trial is to evaluate the safety and efficacy of QLP2117 in combination with QL2107 in Advanced Solid Tumor Patients.

Eligibility criteria

Qualifiers

Histological or cytological confirmation of recurrent or refractory advanced solid tumours, and have progressed on standard therapy, or are intolerable for available standard therapy, or there is no available standard therapy.

At least one measurable disease for expansion cohorts per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1(phase Iba dose escalation only requires at least one assessable lesion)

Eastern Cooperative Oncology Group Performance Status of 0 or 1

Agree to provide archived tumor tissue samples of primary or metastatic lesions.

Disqualifiers

Women who are pregnant or breastfeeding

HBsAg/HBcAb positive and HBV-DNA>1000 copy/mL;HCV-Ab positive and detection of HCV-RNA suggested viral replication

Is currently participating and receiving study medication in another study within 4 week prior to the first dose of study treatment

Has an active autoimmune disease that has required systemic treatment in past 2 years.

Trial design

Treatments tested in this trial

  • QLP2117
  • QL2107

Treatment groups

149 Participants
are divided into 1 treatment group

Sponsors and collaborators