Safety, Tolerability and Efficacy of MB07133 Plus Sintilimab in Patients With Hepatocellular Carcinoma,a Phase 1/2a Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

An open-label, multi-dose clinical trial design was used to investigate the combination of MB07133 injection combined with Sintilimab in the treatment of primary liver cancer in phase I/IIa studies, including two phases of dose escalation and dose expansion,in order to evaluate the safety and efficacy of MB07133 injection combined with Sintilimab.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Age range from 18 to 70 years old (including 18 and 70 years old), regardless of gender;

• Non resectable hepatocellular carcinoma/mixed liver cancer confirmed by pathological diagnosis (pathological tissue/cytology) or clinical diagnosis (dynamic enhanced MRI/dynamic enhanced CT scan);

• At least one measurable lesion in the liver (in accordance with RECISIT1.1 standard);

• Child-Pugh liver function score: A/B (≤ 7 points);

• Expected survival time ≥ 12 weeks;

• ECOG score of 0 or 1;

• Patients who have completed chemotherapy/radiotherapy for tumors for more than 4 weeks (those who have received nitrosoureas and mitomycin chemotherapy for more than 6 weeks, those who have received small molecule targeted drugs (such as sorafenib and lovatinib) for more than 2 weeks), or those who have completed chemotherapy/radiotherapy for more than 5 half-lives (time limit whichever is longer), and those who have received the last intervention, radiotherapy, surgery, and ablation treatment for more than 4 weeks;

• Not using any anti-tumor drugs within 2 weeks before the first medication;

• Active hepatitis B patients should be controlled accordingly, and continue to take antiviral drugs and monitor liver function Can and hepatitis B virus load (such as: HBV DNA\<104 copies/ml (2000IU/ml)).

⁃ If the main organ function is normal, it meets the following standards: blood routine examination: HGB ≥ 90 g/L; ANC ≥ 1.5 × 109/L; PLT ≥ 80 × 109/L; Blood biochemical test: ALB ≥ 28 g/L; ALT and AST ≤ 5.0 × ULNTBIL ≤ 1.5 × ULN; Creatinine ≤ 1.5 × ULN; The electrolyte is normal or normal after treatment or judged by the researcher to be abnormal without clinical significance; Urinary routine examination: Urinary protein ≤ 1+, if urinary protein ≥ 2+but 24-hour urinary protein\<1.0g, it can be included in the group; ECG results: QTcB\<470ms for males and\<480ms for females; Thyroid function: Thyroid stimulating hormone (TSH) and free thyroxine (FT3) are within the normal range or have been determined by researchers to be abnormal without clinical significance.

⁃ Female patients of childbearing age or male patients with sexual partners of childbearing age should take effective contraceptive measures throughout the entire treatment period and 6 months after the last medication; Women of childbearing age cannot be in pregnancy or lactation.

⁃ The patient voluntarily signs a written informed consent form and is able to comply with the visit and related procedures stipulated in the plan.

Locations
Other Locations
China
The First Hospital of Jilin University
RECRUITING
Jilin
Contact Information
Primary
Ding Yanhua
1023307193@qq.com
18743062721
Time Frame
Start Date: 2022-01-18
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 39
Treatments
Experimental: MB07133+Sintilimab
The test is divided into 2 stages: fist stage is dose escalation:Sintilimab 200mg,MB07133 injection is divided into three dosage groups: 600mg/m2/day, 1200mg/m2/day, and 1800mg/m2/day.~second stage Dose expansion:Sintilimab 200mg+MB07133 1800mg/m2/day
Related Therapeutic Areas
Sponsors
Collaborators: The First Hospital of Jilin University
Leads: Xi'an Xintong Pharmaceutical Research Co.,Ltd.

This content was sourced from clinicaltrials.gov

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