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

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06132828
• Other study ID #: DR30206101
• Status: Recruiting
• Phase: Phase 1
• Start date: November 27, 2023
• Est. completion date: July 30, 2026

Study information

• Verified date: November 2023
• Source: Zhejiang Doer Biologics Co., Ltd.
• Contact: Senior Clinical Operations Director
• Phone: +86 151 94 40 28 68
• Email: yg[@]doerbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 182
• Est. completion date: July 30, 2026
• Est. primary completion date: March 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Drug:
• DR30206
Subjects receive DR30206 intravenously

Locations

Country	Name	City	State
China	Shanghai Pulmonary Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Doer Biologics Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PartA: Incidence of dose limiting toxicities (DLTs)	Dose-limiting describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment	21 days following first dose
Primary	PartA: Maximum tolerated dose (MTD)	As measured by number of participants experiencing dose related toxicity (DLT) in each escalating cohort	21 days following first dose
Primary	PartA: Recommend dose of expansion(RDE)	A Recommend dose of expansion will be determined based on safety data	21 days following first dose
Primary	PartA+B: Adverse evens (AEs)	The incidence and severity of AEs graded according to NCI-CTCAE v5.0	Up to 90 days after last dose
Primary	PartA+B: Serious adverse evens (SAEs)	A Serious Adverse Event (SAE) is an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect	Up to 90 days after last dose
Primary	PartB: Objective response rate (ORR)	Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1	Up to approximately 12 months
Primary	PartB: Recommended phase 2 dose (RP2D)	A recommended phase 2 dose will be determined based on safety data	21 days following first dose