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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Contact
Study Contact
- Name: Chief Operating Officer
- Phone Number: +86 05 71 28 25 62 06
- Email: yf@doerbio.com
Study Contact Backup
- Name: Senior Clinical Operations Director
- Phone Number: +86 151 94 40 28 68
- Email: yg@doerbio.com
Study Locations
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, China, 200433
- Recruiting
- Shanghai Pulmonary Hospital
-
Contact:
- Zhou Caicun, MD
- Phone Number: +86 021 6511 5006
- Email: caicunzhoudr@126.com
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: DR30206
Subjects receive DR30206 monotherapy intravenously(IV) until no more benefits from treatment.
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Subjects receive DR30206 intravenously
Other Names:
|
|
Experimental: Phase Ib: DR30206
The non-small cell lung cancer subjects receive DR30206 (30mpk,Q3W) monotherapy intravenously(IV) until no more benefits from treatment.
|
Subjects receive DR30206 intravenously
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PartA: Incidence of dose limiting toxicities (DLTs)
Time Frame: 21 days following first dose
|
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
|
|
PartA: Maximum tolerated dose (MTD)
Time Frame: 21 days following first dose
|
As measured by number of participants experiencing dose related toxicity (DLT) in each escalating cohort
|
21 days following first dose
|
|
PartA: Recommend dose of expansion(RDE)
Time Frame: 21 days following first dose
|
A Recommend dose of expansion will be determined based on safety data
|
21 days following first dose
|
|
PartA+B: Adverse evens (AEs)
Time Frame: Up to 90 days after last dose
|
The incidence and severity of AEs graded according to NCI-CTCAE v5.0
|
Up to 90 days after last dose
|
|
PartA+B: Serious adverse evens (SAEs)
Time Frame: Up to 90 days after last dose
|
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
|
|
PartB: Objective response rate (ORR)
Time Frame: Up to approximately 12 months
|
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
|
|
PartB: Recommended phase 2 dose (RP2D)
Time Frame: 21 days following first dose
|
A recommended phase 2 dose will be determined based on safety data
|
21 days following first dose
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Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Chair: Yanshan Huang, PhD, Zhejiang Doer Biologics Co., Ltd.
- Study Director: Junfang Xu, MD, Huadong Medicine Co., Ltd.
- Principal Investigator: Caicun Zhou, MD, Shanghai Pulmonary Hospital, Shanghai, China
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- DR30206101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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