A Phase I Study Evaluating SCB-313 for the Treatment of Subjects With Peritoneal Carcinomatosis

NCT04047771 | Terminated Phase 1

• 1 other identifier: CLO-SCB-313-CHN-003
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and tolerability of SCB-313 in patients with peritoneal carcinomatosisa, to determine the maximum tolerated dose (MTD) and/or extended study recommended dose (RDE) for SCB-313 intraperitoneal injection, providing a basis for dosing regimen and dose choosing in clinical trial subsequently.

Conditions

Peritoneal Carcinomatosis

Outcome Measures

Primary Outcomes (2)

• Dose Limiting Toxicity (DLT)

  DLT

  21 days after first dosing

• Occurrence of adverse events (AEs) and serious adverse events (SAEs)

  AEs

  21 days after first dosing

Secondary Outcomes (5)

• Immunogenicity

  28 days after last dosing

• Pharmacokinetics (Cmax)

  Up to 24 hours after dosing

• Pharmacokinetics (tmax)

  Up to 24 hours after dosing

• Pharmacokinetics ([AUC]0-24)

  Up to 24 hours after dosing

• Pharmacokinetics (AUC 0-inf)

  Up to 24 hours after dosing

Study Arms (1)

SCB-313

EXPERIMENTAL

Drug: SCB-313

Interventions

SCB-313 DRUG

Intraperitoneal injection, 3 doses on D1,D4,D7，21 days for 1 cycle

Also known as: recombinant human TRAIL-Trimer fusion protein

SCB-313

Eligibility Criteria

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

You may qualify if:

• Be able to understand and voluntarily sign written informed consent.
• Male or female subjects, age ≥18, ≤75 years.
• Confirmed by histopathology or cytopathology, any primary or secondary malignant peritoneal carcinomatosis subject.
• Progression after standard treatment, or inability to tolerate standard treatment, or no standard treatment.
• ECOG status 0 to 2 or KPS status \> 60
• CT-PCI (Peritoneal Carcinomatosis Index) status ≥ 15
• Life expectancy of at least 3 months.
• No serious hematologic, hepatic, renal dysfunction, comply with the following laboratory test results:
• Hematology: white blood cell count \>3\*109/L, absolute neutrophil count ≥1.5\*109/L, platelets \> 75\*109/L, hemoglobin \> 90 g/L.
• Liver function: aspartate aminotransferase and alanine aminotransferase ≤ 3 times ULN, Alkaline phosphatase (ALP) ≤ 2.5 times ULN; serum total bilirubin (TBIL) ≤ 1.5 times ULN.
• Renal function: Creatinine clearance calculated according to the Cockcroft-Gault formula ≥ 50 mL/min.
• All adverse events from previous system anticancer treatment return to baseline or ≤ grade 1 (except for alopecia and vitiligo, neuropathy which induced by previous anticancer therapy status stable or ≤ grade 2).
• Male or female subjects undergo effective contraception during treatment and within 6 months after last dose.

You may not qualify if:

• Previous treatment with TRAIL pathway drug.
• Malignant cancer diseases other than malignant peritoneal carcinomatosis in this study (Exceptions include: a cured malignant cancer without relapse within 3 years prior to the study enrollment, completely resected basal cells and squamous cell skin cancer, and any type of carcinoma in situ).
• Primary lesion invades the central nervous system (CNS) with symptoms develop, status unstable or require high dose steroids (e.g. dexamethasone ≥ 10 mg or equivalent dose) to control.
• Abnormal HBV examination, anti-HCV positive, anti-HIV antibody positive or other serious infections requiring systemic treatment within 4 weeks prior to first dosing (e.g. virus, bacteria or fungus).
• Use the following concomitant therapy before dosing:
• Use drug that prolongs the QT interval and/or associated with the risk of torsades de pointes ventricular tachycardia (TdP) within 7 days prior to first dosing.
• Use amiodarone within 90 days prior to first dosing.
• Impaired heart function or clinically significant cardiovascular disease, including any of the following:
• Cerebrovascular accident/stroke (within 6 months prior to enrollment).
• Myocardial infarction (within 6 months prior to enrollment).
• Unstable angina, congestive heart failure (New York Heart Association grade ≥ II) or severe arrhythmia requiring medication (including QT/QTc interval extension \>480 msec, installation of pacemakers, etc.).
• Left ventricular ejection fraction \< 50% as determined by echocardiography.
• Active bleeding history or gastrointestinal perforation risk within 4 weeks before enrollment, or not healed from recent surgery.
• Received anticancer treatment within following specified time before first dosing:
• Received medical treatment ≤ 4 weeks or 5 times known drug half-life (whichever is longer).

Sponsors & Collaborators

• Sichuan Clover Biopharmaceuticals, Inc.: lead

Study Sites (1)

Beijing Shijitan Hospital Capital Medical University

Beijing, Beijing Municipality, 100038, China

Location

MeSH Terms

Conditions

Peritoneal Neoplasms

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases

Study Design

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

Study Record Dates

• First Submitted: August 5, 2019
• First Posted: August 7, 2019
• Study Start: September 10, 2019
• Primary Completion: May 5, 2022
• Study Completion: May 5, 2022
• Last Updated: April 12, 2023

Record last verified: 2023-04

Locations

CN (1)