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

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

NCT ID: NCT06132828

Condition: Solid Tumor

Conditions: Official terms:
Neoplasms

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: DR30206
Description: Subjects receive DR30206 intravenously
Arm group label: DR30206

Other name: DR30206 for Injection

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

Detailed description: This study is an open, phase I study to evaluate the safety, tolerability, pharmacokinetics of DR30206 in patients with advanced or metastatic solid tumors. The study is composed of two parts: part A is Dose escalation stage and part B is Dose expansion stage

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Voluntarily sign a written informed consent form 2. Patients must be ≥ 18 and ≤75 years of age 3. 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 4. Part B: Subjects with advanced or metastatic specific types of tumors confirmed by histology or cytology who have failed or are intolerant to standard therapy or have no effective standard therapy 5. 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 6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0 or 1 7. The expected survival period ≥3 months 8. Adequate bone marrow, liver, and renal function 9. 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 10. 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 Criteria: 1. Patients with a history of severe allergies to monoclonal antibodies (mAb) or bispecific antibodies, or known allergies to drug component of the study drug 2. Patients with active malignant tumors within the past 2 years, except for the tumors participating in the study and locally cured tumors 3. 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 4. 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) 5. Radical radiotherapy within 3 months before starting the study treatment 6. 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 7. Known active central nervous system (CNS) metastasis 8. There have been clinically significant cardiovascular and cerebrovascular diseases within 6 months prior to the first study drug dosing 9. Active stage of autoimmune disease or immune deficiency or history of autoimmune disease or immune deficiency 10. 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 11. Active or previously diagnosed inflammatory bowel disease (such as Crohn's disease, ulcerative colitis) 12. During the screening period, there were a large or symptomatic moderate amount of pleural effusion, pericardial effusion, and abdominal effusion 13. 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 14. Previous or current complications such as gastrointestinal perforation surgery, wound healing, and bleeding events 15. 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) 16. Receiving full dose oral or parenteral anticoagulant or thrombolytic therapy, but still unstable for at least 2 weeks before the first study drug dosing 17. 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) 18. Known active infection 19. The subject has previously received allogeneic stem cell or organ transplantation 20. History of organ or hematopoietic stem cell transplantation that requires the use of immunosuppressants 21. 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 22. 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 23. Participants who are not appropriate for this clinical trial at the discretion of the investigator

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Shanghai Pulmonary Hospital

Address:
City: Shanghai
Zip: 200433
Country: China

Status: Recruiting

Contact:
Last name: Zhou Caicun, MD

Phone: +86 021 6511 5006
Email: caicunzhoudr@126.com

Start date: November 27, 2023

Completion date: July 30, 2026

Lead sponsor:
Agency: Zhejiang Doer Biologics Co., Ltd.
Agency class: Industry

Source: Zhejiang Doer Biologics Co., Ltd.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06132828