RecruitingPhase 1NCT06132828

Evaluate the Safety, Tolerability, Pharmacokinetics of DR30206 in Patients With Advanced or Metastatic Solid Tumors

A Multicenter, Open-Label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics of DR30206 in Patients With Advanced or Metastatic Solid Tumors

Sponsor

Zhejiang Doer Biologics Co., Ltd.

Enrollment

216 participants

Start Date

Nov 27, 2023

Study Type

INTERVENTIONAL

Conditions

Solid Tumor

Summary

This study is to characterize the safety,tolerability, pharmacokinetics(PK),and preliminary anti-tumor activity of DR30206, in subjects with advanced or metastatic solid tumors

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria10

Voluntarily sign a written informed consent form
Patients must be ≥ 18 and ≤75 years of age
Part A: Subjects with advanced or metastatic malignant solid tumors confirmed by histology or cytology who have failed or are intolerant to standard therapy or have no effective standard therapy
Part B: The NSCLC cohort is planned to enroll patients with histologically or cytologically confirmed NSCLC who have locally advanced or metastatic NSCLC and are not eligible for curative treatment; patients must have no histologically confirmed EGFR-sensitive mutations or ALK gene fusions; they must not have received prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC; and they must provide tumor tissue samples (approximately 5 unstained slides) obtained at the time of or after diagnosis of locally advanced or metastatic disease and within 2 years, without radiotherapy, which must be confirmed by the central laboratory to have tumor PD-L1 TPS ≥1%. Other potential cohorts may include patients with histologically or cytologically confirmed advanced or metastatic specific tumor types who have failed standard therapy, are intolerant to standard therapy, or have no effective standard therapy. These include, but are not limited to, cervical cancer, hepatocellular carcinoma, TNBC (Triple Negative Breast Cancer), and other tumor types such as gastric cancer, ovarian cancer, colorectal cancer, and tumor types with efficacy signals (CR/PR) identified during the dose escalation phase.
Patients in part A must have at least one evaluable lesion, and in part B must have at least one measurable lesion according to RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0 or 1
The expected survival period ≥3 months
Adequate bone marrow, liver, and renal function
Male or female subjects with fertility must agree to take effective contraceptive measures during the study period and within 6 months after the end of the last medication
Be able to understand the procedures and methods of this study, and willing to strictly follow the clinical trial protocol to complete this study

Exclusion Criteria23

Patients with a history of severe allergies to monoclonal antibodies (mAb) or bispecific antibodies, or known allergies to drug component of the study drug
Patients with active malignant tumors within the past 2 years, except for the tumors participating in the study and locally cured tumors
Severe chronic or active infections, including but not limited to hospitalization due to complications of infection, bacteremia, or severe pneumonia, or any active infection that the investigator believes may affect the safety of the subject, within 4 weeks prior to the start of the study treatment; Systemic antibiotic treatment within 2 weeks before starting the study treatment
Received the following treatments or medications within 4 weeks before starting the study treatment: a. Interventional clinical studies; b. Major surgery or severe traumatic injury, or expected to require major surgery during the study process; c. Inoculate live attenuated vaccines, or expect to receive such vaccines during the study treatment period or within 5 months after the last administration of the study treatment; Systemic treatment with anti-tumor drugs, or local anti-tumor therapy, or treatment with systemic immune stimulators (including but not limited to interferon or interleukin-2 (IL-2)
Radical radiotherapy within 3 months before starting the study treatment
Received systemic immunosuppressive medication treatment within 4 weeks prior to the start of the study, or is expected to require systemic immunosuppressive medication during the study treatment period
Known active central nervous system (CNS) metastasis
There have been clinically significant cardiovascular and cerebrovascular diseases within 6 months prior to the first study drug dosing
Active stage of autoimmune disease or immune deficiency or history of autoimmune disease or immune deficiency
Have a history of interstitial pneumonia, idiopathic pulmonary fibrosis, organized pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia, idiopathic pneumonia, or evidence of active pneumonia found on screening chest CT scans; Previously used hormone therapy for pneumonia
Active or previously diagnosed inflammatory bowel disease (such as Crohn's disease, ulcerative colitis)
During the screening period, there were a large or symptomatic moderate amount of pleural effusion, pericardial effusion, and abdominal effusion
During the screening period, imaging showed that the tumor were surrounded by important blood vessels or had obvious necrosis or cavities, and the investigators determined that enrolling into the study would pose a risk of bleeding
Previous or current complications such as gastrointestinal perforation surgery, wound healing, and bleeding events
Current or recent use of aspirin (>325 mg/day) or treatment with clopidogrel, clopidogrel, and cilostazol (within 10 days prior to the first study drug dosing)
Receiving full dose oral or parenteral anticoagulant or thrombolytic therapy, but still unstable for at least 2 weeks before the first study drug dosing
Adverse reactions caused by previous treatment that have not recovered to CTCAE 5.0 level 1 or below (but pigmentation, hair loss, etc. can be included if the investigator deems that there is no safety risk)
Known active infection
The subject has previously received allogeneic stem cell or organ transplantation
History of organ or hematopoietic stem cell transplantation that requires the use of immunosuppressants
Pregnant or lactating women, defined as women in a state of pregnancy until termination of pregnancy, are determined by laboratory human chorionic gonadotropin (hCG) testing within 7 days prior to the start of the study
Any other disease, medical condition or abnormality, metabolic dysfunction, alcohol or drug abuse or dependence, physical examination or lab testing results that potential impact on result interpretation or will increase the likelihood of complications for patients
Participants who are not appropriate for this clinical trial at the discretion of the investigator