Clinical trial NCT05099536: 3D011-08 Monotherapy in Subjects With Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Solid Tumor, Adult
Lead sponsor: 3D Medicines
Sponsor class: INDUSTRY
First posted: 2021-10-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Maximum Tolerated Dose (MTD) of3D011-08
timeFrame: 24 months
measure: ORR
timeFrame: 24 Months
measure: TTP
timeFrame: 24 Months
Secondary outcomes:
measure: RPTD
timeFrame: 24 months
measure: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
timeFrame: 24 months
measure: Cmax Cmax
timeFrame: 24 months
measure: Css min
timeFrame: 24 months
measure: Tmax
timeFrame: 24 months
measure: AUC0~t、AUC0~∞
timeFrame: 24 months
measure: Ctrough
timeFrame: 24 months
measure: t1/2
timeFrame: 24 months
measure: CL
timeFrame: 24 months
measure: Vd
timeFrame: 24 months
measure: ORR
timeFrame: 24 months
measure: Duration of response (DoR)
timeFrame: 24 months
measure: Disease control rate (DCR)
timeFrame: 24 months
measure: Progression-free survival (PFS)
timeFrame: 24 months
measure: Permeable surface area of capillary wall(PS)
timeFrame: 24 months
measure: the incremental Area Under Curve (iAUC)
timeFrame: 24 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Floor 2, Building 2, 270 Dong 'an Road, Xuhui District
Study officials:
affiliation: Fudan University
name: dingwei Ye, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: jiang zhang, Dr
role: PRINCIPAL_INVESTIGATOR
References: