- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05099536
3D011-08 Monotherapy in Subjects With Advanced Solid Tumors
A Phase I Study of the Safety, Tolerability, Pharmacokinetics Profiles and Preliminary Efficacy of 3D011-08 for Injection Monotherapy in Subjects With Advanced Solid Tumors
Study Overview
Detailed Description
Study Type
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: yanyan cheng
- Phone Number: 15618670457
- Email: yanyan.cheng@3d-medicines.com
Study Locations
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Floor 2, Building 2, 270 Dong 'an Road, Xuhui District
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Shanghai, Floor 2, Building 2, 270 Dong 'an Road, Xuhui District, China
- Fudan University Shanghai Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Histologically or cytologically confirmed locally advanced or metastatic malignant solid tumors(part 1 dose escalation); Histologically confirmed locally advanced or metastatic hepatocellular carcinoma (cohort 1),advanced renal cell carcinoma (cohort 2), and metastatic castration-resistant prostate cancer (cohort 3) for which not amenable to local therapy.(part 2 dose expansion).
- Cohort 1 and 2: at least one measurable lesion (according to RECIST 1.1 criteria);Cohort 3: at least one measurable or unmeasurable lesion (according to RECIST 1.1 criteria).
Subjects must have failed or have been intolerant to established standard therapies, or standard therapies did not exist or were no longer effective for a given tumor type, or in the opinion of the Investigator have been considered ineligible for a particular form of standard therapy on medical grounds(part 1 dose escalation). Cohort 1 (advanced hepatocellular carcinoma)and Cohort 2 (advanced renal cell carcinoma): Subjects had disease progression after received previous first-line of systemic treatment, or subjects are intolerant of or have refused to receive first-line of systemic treatment.
Cohort 3 (metastatic castration-resistant prostate cancer) : Patients who had failed or had refused prior abiraterone and/or docetaxel chemotherapy.(part 2 dose expansion)
- ECOG Performance Status ≤ 2(part 1 dose escalation).≤ 1.(part 2 dose expansion)
- Life expectancy ≥ 12 weeks.
- Adequate organ and bone marrow function.
Exclusion Criteria:
- Investigational products or devices in other clinical trials or received antibody drug therapy within 4 weeks before the first dose,or chemotherapy, targeted therapies,or radiotherapy within 2 weeks before the first dose.
- Participants need to continue using medications known to have a significant risk of causing QTc prolongation or a CYP3A4 strong inhibitor or strong inducer.
- Participants who have previous toxicity of anti-tumor therapy that has not been returned to level 0 or 1.
- Participants with diseases at risk of bleeding within 3 months prior to enrollment
- Participants with concomitant medical conditions requiring anticoagulant therapy at a therapeutic dose
- History or current condition of uncontrolled cardiovascular disease.
- Participants with gastrointestinal disease associated with a risk of perforation or fistula formation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 3D011-08
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participants will receive 15mg (starting dose)intravenous drop of 3D011-08,All subjects in each cohort will receive a single dose of 3D011-08 first, followed by a 7-day washout period (i.e.
single-dose PK study period).
Then, subjects will receive consecutive doses on 1,3,5day of each week (28 days/cycle) until disease progression, death, unacceptable toxicity, or withdraw of informed consent, whichever comes first.Dose of the study medication will be escalated sequentially till the dose limiting toxicity is achieved to determine the recommended part 2 doses (RPTD).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Tolerated Dose (MTD) of3D011-08
Time Frame: 24 months
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The maximum tolerated dose as determined in Part 1 of the study will be used as the recommended dose for Part 2.
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24 months
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ORR
Time Frame: 24 Months
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proportion of subjects in cohort 1 and cohort 2 who achieved a confirmed complete response (CR) or partial response (PR) based on RECIST v1.1 as assessed by investigators.
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24 Months
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TTP
Time Frame: 24 Months
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time to progression based on the PCWG3 recommendations for assessment of prostate cancer disease progression (CT/MRI, bone scan) as assessed by investigators .
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24 Months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Time Frame: 24 months
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24 months
|
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RPTD
Time Frame: 24 months
|
RP2D will be determined based on pharmacodynamics or clinical response, as well as the incidence rate and nature of the toxicities observed.
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24 months
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Cmax Cmax
Time Frame: 24 months
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24 months
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Css min
Time Frame: 24 months
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24 months
|
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Tmax
Time Frame: 24 months
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24 months
|
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AUC0~t、AUC0~∞
Time Frame: 24 months
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24 months
|
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Ctrough
Time Frame: 24 months
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24 months
|
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t1/2
Time Frame: 24 months
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24 months
|
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CL
Time Frame: 24 months
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24 months
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Vd
Time Frame: 24 months
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24 months
|
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ORR
Time Frame: 24 months
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proportion of subjects in part of Dose Escalation who achieved a confirmed complete response (CR) or partial response (PR) based on RECIST v1.1 as assessed by investigators.proportion of subjects in dose expansion cohort 3 who achieved a confirmed complete response (CR) or partial response (PR) based on the PCWG3 recommendations for assessment of prostate cancer disease progression (CT/MRI, bone scan) as assessed by investigators .
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24 months
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Duration of response (DoR)
Time Frame: 24 months
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DoR is defined as the time from the date of first CR or PR based on RECIST v1.1 to the date of first documented progressive disease based on RECIST v1.1 or death, whichever occurs first.part1
Dose Escalation,part 2 dose expansion:Cohort 1 and Cohort 2.
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24 months
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Disease control rate (DCR)
Time Frame: 24 months
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defined as the proportion of subjects who achieve a confirmed complete response (CR) or partial response (PR) or stable disease (SD) based on RECIST v1.1 as assessed by investigators.Proportion of subjects in dose expansion cohort 3 who achieve a confirmed complete response (CR) or partial response (PR) or stable disease (SD) based on the PCWG3 recommendations for assessment of prostate cancer disease progression (CT/MRI, bone scan) as assessed by investigators .
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24 months
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Progression-free survival (PFS)
Time Frame: 24 months
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PFS is defined as the time from the date of first study dose to disease progression based on RECIST v1.1 or death, whichever occurs first.
Subjects in dose expansion cohort 3 based on the PCWG3 recommendations for assessment of prostate cancer disease progression (CT/MRI, bone scan) as assessed by investigators .
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24 months
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Permeable surface area of capillary wall(PS)
Time Frame: 24 months
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24 months
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the incremental Area Under Curve (iAUC)
Time Frame: 24 months
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24 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: dingwei Ye, Dr, Fudan University
- Principal Investigator: jiang zhang, Dr, Fudan University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3D011-CN-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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