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Solid Tumor, AdultPhase 1NCT05099536

3D011-08 Monotherapy in Subjects With Advanced Solid Tumors

A Phase 1 study testing 3D011-08 in people with Solid Tumor, Adult, run by 3D Medicines (Beijing) Co., Ltd. at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is evaluate the the safety, tolerability, pharmacokinetics profiles, and preliminary efficacy of 3D011-08 in subjects with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor, Adult
What is being tested?
3D011-08
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteChina
Study dates
24 Feb 2022to 11 Sep 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai, Floor 2, Building 2, 270 Dong 'an Road, Xuhui District

Other trials in China

About this study

Official title: 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

The purpose of this study is evaluate the the safety, tolerability, pharmacokinetics profiles, and preliminary efficacy of 3D011-08 in subjects with advanced solid tumors.

Read the detailed description

Detailed Description: This study was initiated on February 24, 2022, at Fudan Cancer Hospital. However, noparticipants were screened or enrolled after the initiation. Due to strategic development adjustments, thecompany terminated the study on September 11. 2023.

Being tested
3D011-08

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3D011-08Drug

    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).

Study groups in NCT05099536
Study groupRoleWhat they receive
3D011-08ExperimentalNot described
Receives: Drug: 3D011-08

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Tolerated Dose (MTD) of3D011-08

    The maximum tolerated dose as determined in Part 1 of the study will be used as the recommended dose for Part 2.

    Measured: 24 months

  2. ORR

    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.

    Measured: 24 Months

  3. TTP

    time to progression based on the PCWG3 recommendations for assessment of prostate cancer disease progression (CT/MRI, bone scan) as assessed by investigators .

    Measured: 24 Months

Secondary outcomes (16)

  1. RPTD

    RP2D will be determined based on pharmacodynamics or clinical response, as well as the incidence rate and nature of the toxicities observed.

    Measured: 24 months

  2. Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

    Measured: 24 months

  3. Cmax Cmax

    Measured: 24 months

  4. Css min

    Measured: 24 months

  5. Tmax

    Measured: 24 months

  6. AUC0~t、AUC0~∞

    Measured: 24 months

  7. Ctrough

    Measured: 24 months

  8. t1/2

    Measured: 24 months

  9. CL

    Measured: 24 months

  10. Vd

    Measured: 24 months

  11. ORR

    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 .

    Measured: 24 months

  12. Duration of response (DoR)

    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.

    Measured: 24 months

  13. Disease control rate (DCR)

    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 .

    Measured: 24 months

  14. Progression-free survival (PFS)

    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 .

    Measured: 24 months

  15. Permeable surface area of capillary wall(PS)

    Measured: 24 months

  16. the incremental Area Under Curve (iAUC)

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2021
  2. Study start24 Feb 2022
  3. Primary completion11 Sep 2023
  4. Study completion11 Sep 2023

Why it stopped: Company's decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05099536
Sponsor's protocol ID
3D011-CN-001
Status last verified
Jan 2024
First submitted
11 Oct 2021
Last updated
31 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 3D011-08 in people with Solid Tumor, Adult, run by 3D Medicines (Beijing) Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD) of3D011-08 (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05099536.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.

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