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

NCT05508620 | Unknown Phase 1

• 1 other identifier: HB1901-003
• Study Type: interventional
• Target: 270
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an open-label, multi-center phase 1b study to evaluate the safety and efficacy of Sirolimus for injection (albumin-bound) in patients with malignant solid tumors with TSC1 or TSC2 genetic alterations.

Conditions

Malignant Solid Tumors

Outcome Measures

Primary Outcomes (3)

• Dose-limiting toxicities (DLT)

  At the end of Cycle 1 (each cycle is 21 days)

• Recommended phase 2 dose (RP2D)

  Up to 2 years

• Overall response rate (ORR)

  Up to 2 years

Secondary Outcomes (7)

• Disease Control Rate (DCR)

  Up to 2 years

• Duration of Response (DOR)

  Up to 2 years

• Progression-free Survival (PFS)

  Up to 2 years

• Overall survival (OS)

  Up to 2 years

• Maximum Plasma Concentration (Cmax)

  Up to18 weeks

Study Arms (1)

Sirolimus for Injection (Albumin-bound)

EXPERIMENTAL

Treatment with Sirolimus for Injection (Albumin-bound) will continue until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurs first.

Drug: Sirolimus for Injection (Albumin-bound)

Interventions

Sirolimus for Injection (Albumin-bound) DRUG

Intravenous infusion

Sirolimus for Injection (Albumin-bound)

Eligibility Criteria

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

You may qualify if:

• Patients must have histologically or cytologically confirmed diagnosis of malignant solid tumors, with TSC1 or TSC2 genetic alterations, and have no standard treatment or have failed standard treatments.
• Patients must have archival tumor tissues or agreed to have a tumor biopsy (if not, the sponsor's consent is required for enrollment).
• At least 1 measurable lesion as defined by RECIST 1.1.
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
• Life expectancy of ≥3 months.
• Adequate marrow and organ function.
• Fasting serum triglyceride must be \<300 mg/dL or \<3.42 mmol/L; fasting serum cholesterol must be\<350 mg/dL or \<9.07 mmol/L.
• Fasting blood glucose must be\<6.1 mmol/L and HbA1c\< 6.5% in dose escalation, in other stage must be \< 7.8 mmol/L and be\< 8% respectively.
• Women of child-bearing potential, or men whose partners are women of childbearing age must agree to use reliable contraceptive methods during the trial period and at least 6 months after the last administration; women of childbearing age must have a negative serum pregnancy test within 7 days prior to the first administration, should not be breast feeding.
• Patients should understand and willingness to sign a written informed consent form prior to study entry.

You may not qualify if:

• Prior treatment with an mTOR inhibitor.
• Anti-tumor treatment within 4 weeks prior to first dose of study treatment.
• Participation in another therapeutic clinical trial with 4 weeks before study treatment.
• Major surgery within 4 weeks prior to study treatment, or have not fully recovered from any previous procedure.
• Unresolved toxicity from prior anti-tumor therapy greater than Grade 1 as per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
• Patients with primary brain tumors or PEComa.
• Active uncontrolled or symptomatic central nervous system metastasis (CNS) or meningeal metastasis.
• History of serious cardiovascular disease.
• History of serious lung disease, such as interstitial lung disease and/or pneumonitis, or pulmonary hypertension, or pre-existing severely impaired lung function.
• Hydrothorax, ascites or pleural effusion with clinical symptoms or required treatment.
• Patients with hepatocellular carcinoma (HCC): Child-Pugh class B or C; or HCC with ≥50% liver occupation; or has a history or current evidence of hepatic encephalopathy; portal vein invasion at the main portal branch (Vp4).
• Live vaccine (including live attenuated vaccine) within 30 days before signing the informed consent.
• Infection that required systemic anti-infective therapy within 2 weeks before enrollment.
• History of autoimmune disease or immunodeficiency disease.
• Active Hepatitis B or Hepatitis C.

Sponsors & Collaborators

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

MeSH Terms

Interventions

Sirolimus; Injections

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Zhehao Piao

CONTACT

+86-024-81916392; pzpy@163.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: August 15, 2022
• First Posted: August 19, 2022
• Study Start: October 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 23, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share