3D011-08 Monotherapy in Subjects With Advanced Solid Tumors

NCT05099536 | Withdrawn Phase 1

• 1 other identifier: 3D011-CN-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Solid Tumor, Adult

Outcome Measures

Primary Outcomes (3)

• 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.

  24 months

• 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.

  24 Months

• TTP

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

  24 Months

Secondary Outcomes (16)

• RPTD

  24 months

• Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

  24 months

• Cmax Cmax

  24 months

• Css min

  24 months

• Tmax

  24 months

Study Arms (1)

3D011-08

EXPERIMENTAL

Drug: 3D011-08

Interventions

3D011-08 DRUG

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).

3D011-08

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• 3D Medicines (Beijing) Co., Ltd.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

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

Location

Study Officials

• dingwei Ye, Dr

  Fudan University

  PRINCIPAL INVESTIGATOR

• jiang zhang, Dr

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: October 29, 2021
• Study Start: February 24, 2022
• Primary Completion: September 11, 2023
• Study Completion: September 11, 2023
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)