3D011-08 Monotherapy in Subjects With Advanced Solid Tumors

NCT ID: NCT05099536

Last Updated: 2024-01-31

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-24
• Study Completion Date: 2023-09-11

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.

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.

Conditions

Solid Tumor, Adult

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

3D011-08

Group Type: EXPERIMENTAL

3D011-08

Intervention Type: 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).

Interventions

3D011-08

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).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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).

2. 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).

3. 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)

4. ECOG Performance Status ≤ 2(part 1 dose escalation).≤ 1.(part 2 dose expansion)

5. Life expectancy ≥ 12 weeks.

6. Adequate organ and bone marrow function.

Exclusion Criteria

1. 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.

2. Participants need to continue using medications known to have a significant risk of causing QTc prolongation or a CYP3A4 strong inhibitor or strong inducer.

3. Participants who have previous toxicity of anti-tumor therapy that has not been returned to level 0 or 1.

4. Participants with diseases at risk of bleeding within 3 months prior to enrollment

5. Participants with concomitant medical conditions requiring anticoagulant therapy at a therapeutic dose

6. History or current condition of uncontrolled cardiovascular disease.

7. Participants with gastrointestinal disease associated with a risk of perforation or fistula formation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

3D Medicines (Beijing) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

dingwei Ye, Dr

Role: PRINCIPAL_INVESTIGATOR

Fudan University

jiang zhang, Dr

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Shanghai Cancer Center

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

Countries

China

Other Identifiers

3D011-CN-001

Identifier Type: -

Identifier Source: org_study_id