Phase I, Open-labeled, Dose-escalation, Dose-expansion Study Evaluating the Safety, Tolerance, Pharmacokinetics, and Activity of IUAb190708 in Patients With Advanced or Recurrent Solid Tumors

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJun Zhou

About this trial

This study is to evaluate a novel cytotoxic anti-PD-L1, IUAb190708, for the treatment of tumor

Eligibility criteria

Qualifiers

Male or female adult, age 18 - 75, understanding and voluntarily signing an informed consent form

A histologically confirmed diagnosis of Metastatic or locally advanced solid tumors, ineffective management of therapeutic regimen or currently no approved treatment available for the tumor, or unsuitable or refusing to receive standard treatment

In Phase Ia, for tumors with approved indications of anti PD-1/PD-L1 treatment, unrestricted to PD-L1 expression; for tumors that have not yet been approved for indications, positive expression of PD-L1 required. In Phase Ib, positive expression of PD-L1 is required

Subjects should provide fresh or archived tissue samples

Disqualifiers

Serious/active infection or infection requiring intravenous antibiotic treatment within 4 weeks prior to the first dose of the study drug

Receiving nitrosourea and mitomycin C within 6 weeks prior to the first dose of the study drug; receiving oral fluorouracil derivatives or small molecule targeted drugs within 2 weeks prior to the first dose or 5 half-lives of the drug (whichever is longer); receiving endocrine therapy, Immunotherapy, or Traditional Chinese Medicine for anti-tumor indications within 2 weeks prior to the first dose of the study drug; receiving other anti-tumor therapies, such as chemotherapy, radiation, biotherapy, besides as described above treatments, within 4 weeks prior to the first dose of the study drug

Having other primary active malignant tumors within 5 years prior to the first dose of the study drug

Having clinically significant cardiovascular diseases,

Trial design

Treatments tested in this trial

  • IUAb190708, a cytotoxic antibody

Treatment groups

90 Participants
are divided into 1 treatment group

Sponsors and collaborators

Jun Zhou

Lead sponsor

ImmunoUrchin

Sponsor institution

Fudan University

Collaborator

Hunan Cancer Hospital

Collaborator

Fujian Cancer Hospital

Collaborator

Shanghai Pulmonary Hospital, Shanghai, China

Collaborator

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Collaborator

Shandong Cancer Hospital and Institute

Collaborator

Anyang Tumor Hospital

Collaborator