A Study of Sirolimus for Injection (Albumin Bound) in Patients With Advanced Solid Tumors

NCT05125523 | Unknown Phase 1

• 1 other identifier: HB1901-CSP-001
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to estimate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of Sirolimus for Injection (Albumin Bound) in patients with solid malignancies.

Conditions

Advanced Solid Tumors

Keywords

Sirolimus for Injection (Albumin Bound)

Outcome Measures

Primary Outcomes (5)

• Number of participants with adverse events

  Up to 3 years

• Dose-Limiting Toxicities (Stage 1)

  Cycle 1 (Up to 28 days)

• Maximum tolerated dose (Stage 1)

  Up to 1.5 years

• Recommended phase 2 dose (Stage 1)

  Up to 1.5 years

• Overall response rate (Stage 2)

  Up to 3 years

Secondary Outcomes (14)

• Area under the plasma concentration versus time curve (AUC)

  Day 1 of cycle 1 to Day 1 of cycle 4 (85 days)

• Peak concentration (Cmax)

  Day 1 of cycle 1 to Day 1 of cycle 4 (85 days)

• Peak time (Tmax)

  Day 1 of cycle 1 to Day 1 of cycle 4 (85 days)

• Distribution volume (Vz)

  Day 1 of cycle 1 to Day 1 of cycle 4 (85 days)

• Elimination half-life (t1/2)

  Day 1 of cycle 1 to Day 1 of cycle 4 (85 days)

Study Arms (1)

Sirolimus for Injection (Albumin Bound)

EXPERIMENTAL

Stage 1：Multiple doses of Sirolimus for Injection (Albumin Bound) will be administered intravenously. Stage 2：RP2D of Sirolimus for Injection (Albumin Bound) as determined during stage 1 will be administered intravenously.

Drug: Sirolimus for Injection (Albumin Bound)

Interventions

Sirolimus for Injection (Albumin Bound) DRUG

Sirolimus for Injection (Albumin Bound), intravenously, once a week, 28 days per cycle (three weeks-on and one week-off)

Sirolimus for Injection (Albumin Bound)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years (inclusive), no gender limitation.
• Patients must have a histologically or cytologically confirmed advanced or metastatic tumor for which no effective standard therapy is available, or have failed or been intolerant to standard therapies.
• At least one measurable lesion per RECIST version 1.1.
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2.
• Life expectancy of ≥3 months.
• Suitable organs and hematopoietic function should be available. Laboratory tests during screening should meet the appropriate criteria.
• Signed informed consent form.

You may not qualify if:

• Prior anticancer treatment or participation in another clinical study within 4 weeks (or 5 half-lives of the treated drug, whichever is longer) prior to the first dose of study drugs.
• Patients who have undergone major surgery within 4 weeks prior to starting study treatment, or who have not fully recovered from previous surgery.
• Unresolved toxicities from prior therapy greater than Grade 1 as per Common Terminology Criteria for Adverse Events (CTCAE) (except alopecia or any other toxicity without safety risks as judged by the investigator).
• History of serious cardiovascular disease.
• Known prior hypersensitivity to study drugs or any component in their formulations.
• Prior treatment with any mTOR inhibitor.
• Has received a live or live-attenuated virus vaccine within 30 days prior to consent.
• Uncontrollable active infection (CTCAE v5.0 ≥grade 2).
• Use of strong inhibitors and inducers of CYP3A4 within 2 weeks prior to receiving the first dose of study drug and still need to continue using this class of drug.
• History of autoimmune diseases, immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency, or organ transplant history.
• HBsAg-positive with HBV viral load (VL) ≥1000 IU/mL; Hepatitis C Virus (HCV)-positive; Anti-treponema pallidum positive.
• Women of child-bearing potential, or men whose partners are women of childbearing age, have not agree to use highly effective methods of contraception during dosing and for 6 months after study drug discontinuation; female patients has a positive serum pregnancy test within 7 days prior to receiving the first dose of study medication; lactating female.
• Has history of other serious diseases judged by the investigator, which will threaten the safety of patients or interfere the study compliance, or other reasons are not suitable for participating in the study.

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Interventions

Sirolimus; Injections

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Jihui Hao

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuekun Yao

CONTACT

0311-67808678; yaoxuekun@mail.ecspc.com

Yue Huang

CONTACT

huangyue@mail.ecspc.com

Study Design

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

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 18, 2021
• Study Start: December 28, 2021
• Primary Completion: June 1, 2024
• Study Completion: November 1, 2024
• Last Updated: January 25, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)