QLP2117 plus QL2107 for advanced solid tumors

A Phase Ib/II Open-Label, Dose-Escalation and Dose-expansion Clinical Study to Evaluate the Safety, Pharmacokinetics, Immunogenicity and Efficacy of QLP2117 in Combination With QL2107 in Advanced Solid Tumor Patients

This trial will test the combination of QLP2117 and QL2107 in people with advanced solid tumors who have progressed on or cannot receive standard treatments.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 149 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Qilu Pharmaceutical Co., Ltd. (industry)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06911827 on ClinicalTrials.gov

What this trial studies

This is a Phase 1/2, single-center trial testing the safety and anti-tumor activity of QLP2117 combined with QL2107 using a dose-escalation phase followed by expansion cohorts. Primary goals include defining a safe dose and observing preliminary signs of tumor response, with tumor assessments by RECIST v1.1. Eligible patients must have histologically or cytologically confirmed recurrent or refractory advanced solid tumors, ECOG 0–1, and provide archived tumor tissue. The trial is sponsored by Qilu Pharmaceutical and is conducted at Sun Yat-sen University Cancer Center in Guangzhou, China.

Who should consider this trial

Good fit: Adults with recurrent or refractory advanced solid tumors who have progressed on or are intolerant of standard therapy, have ECOG performance status 0–1, and at least one measurable (or assessable in phase I) lesion are the intended candidates.

Not a fit: Patients who are pregnant or breastfeeding, have uncontrolled active viral hepatitis or active autoimmune disease, or lack measurable/assessable disease are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the combination could provide a new treatment option that slows tumor growth or shrinks tumors for patients who have exhausted standard therapies.

How similar studies have performed: The QLP2117 plus QL2107 combination appears novel with limited published data, although other early-phase combination regimens in advanced solid tumors have sometimes shown clinical benefit.

Eligibility criteria

Inclusion Criteria:

* 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.
* Have adequate organ function as described in the protocol.

Exclusion Criteria:

* 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.
* Has an active infection requiring systemic therapy
* Has received a live vaccine wihtin 30 days of planned start of study treatment
* Known history of, or any evidence of interstitial lung disease

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: Ruihua Xu, PhD

Conditions: Advanced Solid Tumor