A Multiple Tumor Species, Open and Multi-center Clinical Study of Alpaloritovorelli Antibodies (QL-1706) Combined with Pulsed Low Dose Rate External Irradiation (PLDR) for Disease Progression After Previous Anti-tumor Therapy

Sponsor
Anhui Provincial Hospital
Study ID
NCT06760676
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Pulsed low dose rate radiotherapy (PLDR) — RADIATION
    Radiation 5 times per week, 2Gy each time which divided into 10 pulse doses, each pulse interval was 3 minutes, the dose rate was 0.067 Gy/min, and each treatment time was 30 minutes.
  • Alpaloritovorelli antibodies — DRUG
    PLDR external irradiation therapy was administered simultaneously with 5mg/kg Alpaloritovorelli antibodies for a 3-week regimen, the following maintenance treatment was 2 years.

Study Details

For the recurrent and metastatic tumors after first-line treatment (such as lung cancer, esophageal cancer and cervical cancer), the risk of conventional fractionated secondary radiotherapy is high because the tumor is close to the hollow organs (such as heart, lung and small intestine). According to previous studies, combined chemotherapy regimens are often used, but the disease control rate (DCR) is limited, and drug resistance and poor tolerance of patients are prone to occur. The immune checkpoint inhibitors (ICB) has been considered as a new strategy for maintenance treatment of patients with recurrent and metastatic tumors, but only some patients can respond for a long time. Therefore, how to improve the clinical response rate of ICB has become an urgent problem to be solved. Pulsed low dose rate radiotherapy (PLDR), a new radiotherapy technology emerging in recent years, is expected to become a new way to solve the above difficulties. Alpaloritovorelli antibodies (QL-1706) is a new type of combination antibody independently developed by Qilu Pharmaceutical Co., Ltd. It is composed of IgG4 antibody targeting PD-1 (ipalorimab), and IgG1 antibody targeting CTLA-4 (tuvonralimab) in a fixed proportion. It has the synergistic mechanism of blocking PD-1 and CTLA-4 at the same time. The combination of these two antibodies forms a powerful synergistic effect and forms positive feedback in the tumor immune cycle. Pulsed low dose rate radiotherapy (PLDR) is a safe and feasible option for recurrent tumors with high risk of re-radiotherapy. It also has therapeutic advantages for refractory and massive tumors. The advantages of combined vascular targeting and chemotherapy have been initially demonstrated. As a new anti-tumor therapy, immunotherapy has shown clinical benefits in many types of cancer, but the overall effective rate is still limited, which may be due to the immune "desertification" of the tumor microenvironment. PLDR irradiation is expected to reverse the tumor inhibitory microenvironment by inducing the release of tumor associated antigen and increasing the killing function of T cells, activate tumor immunity and improve the response rate of immunotherapy. Based on this, this study plans to take the lead in carrying out this prospective clinical study through the combination of PLDR external irradiation and ICB treatment (QL-1706).

Key Dates

First listed
Jan 7, 2025
Start date
Dec 1, 2025
Status verified
Dec 2024
Primary completion
May 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pulsed low dose rate radiotherapy (PLDR) combined with Alpaloritovorelli antibodies (QL-1706))

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: 6-12 months ]

Central Contacts

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