Intraperitoneal LSTA1 in CRS-HIPEC

NCT06216561 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: UCSD 807804
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This Study is designed to test an investigational product (IP) called LSTA1 (Study drug). LSTA1 is a drug designed to improve the delivery of anti-cancer treatments, such as chemotherapy. Improved delivery of chemotherapy may result in improved anti-cancer effects when given with hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with peritoneal metastases. Participants will be randomized to receive LSTA1 with HIPEC or HIPEC alone (without LSTA1) at the time of surgery.

Conditions

Colorectal Cancer; Ovarian Carcinoma; Appendix Cancer; Peritoneal Metastases

Outcome Measures

Primary Outcomes (2)

• Adverse events of interest (AE-I)

  The proportion of subjects experiencing an inpatient adverse event of interest (AE-I; gastrointestinal fistula/leak, neutropenia, intra-abdominal abscess, venous thromboembolism, mortality)

  postoperatively from the date of CRS-HIPEC to date of discharge (typically 1-2 weeks)

• Drug concentration in tumor

  Total drug content in tumor, divided by total tumor mass

  at time of surgery

Secondary Outcomes (2)

• Progression-Free Survival and Overall Survival

  5 years

• Adverse Events (AEs)

  30 Days

Study Arms (2)

CRS-HIPEC + LSTA1

EXPERIMENTAL

Experimental Arm

Drug: CRS-HIPEC + LSTA1

CRS-HIPEC alone

ACTIVE COMPARATOR

Control Arm

Procedure: CRS-HIPEC alone

Interventions

CRS-HIPEC + LSTA1 DRUG

LSTA1 given with hyperthermic intraperitoneal chemotherapy (HIPEC) at time of cytoreductive surgery (CRS)

Also known as: Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) + Advanced Solid TumorsCertepetide (LSTA1)

CRS-HIPEC + LSTA1

CRS-HIPEC alone PROCEDURE

Hyperthermic intraperitoneal chemotherapy (HIPEC) alone (without LSTA1) at time of cytoreductive surgery (CRS)

CRS-HIPEC alone

Eligibility Criteria

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

You may qualify if:

• Provision of signed and dated informed consent form.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Participants must have histologically confirmed non-mucinous (\< 50% mucin) colorectal, ovarian, or appendiceal carcinoma with peritoneal metastases who are candidates for (cytoreductive surgery and CRS-HIPEC and have at least one peritoneal tumor nodule \> 5 mm (as determined by routine preoperative imaging and confirmed by intraoperative assessment).
• Eligible and intended to undergo CRS-HIPEC per the investigators. This includes assessment of axial imaging (computed tomography, magnetic resonance imaging, positron emission tomography scan) of chest, abdomen, and pelvis, within 30 days of screening, which reveals peritoneal metastases amenable to complete cytoreduction per the investigators (i.e. limited small bowel/mesenteric metastases), lack of extra-peritoneal metastases (including intra-hepatic and pulmonary metastases), and lack of untreated biliary, gastrointestinal, and urologic obstruction.
• Age ≥ 18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status \< 2.
• Women of child-bearing potential with negative pregnancy test prior to undergoing CRS-HIPEC.
• Adequate contraception for participants able to cause a pregnancy:

You may not qualify if:

• Participants who do not receive HIPEC at the time of CRS.
• Any major surgery or irradiation within 30 days prior to prior to planned date of CRS-HIPEC.
• Active infection (viral, fungal, or bacterial) requiring systemic therapy.
• Known active hepatitis B virus (HBV), hepatitis C virus (HCV), tuberculosis, or human immunodeficiency virus (HIV) infection.
• History of allogeneic tissue/solid organ transplant.
• History or clinical evidence of central nervous system (CNS) metastases without exceptions
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to LSTA1 or other agents used in the study, including those discovered by other ongoing studies of LSTA1 or other agents used in the study.
• Existing venous thromboembolism at the time of CRS-HIPEC.
• Severe or uncontrolled medical disorder that would, in the investigator's opinion, impair ability to undergo CRS-HIPEC and receive study treatment. This includes, but is not limited to the following laboratory values and other parameters within 30 days prior to planned date of CRS-HIPEC:
• Platelets \< 100,000/mm3
• White blood cell count \< 3000/ mm3
• Absolute neutrophil count \< 1,500/mm3
• Serum albumin \< 2.5 g/L
• Alanine transaminase (ALT) and aspartate aminotransferase (AST) \> 2.5 x upper limit of normal (ULN) in the absence of liver metastases or \> 5 x ULN in the presence of liver metastases
• Bilirubin \> 1.5 x ULN

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California San Diego

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Ovarian Neoplasms; Appendiceal Neoplasms

Interventions

Cytoreduction Surgical Procedures; Hyperthermic Intraperitoneal Chemotherapy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Cecal Neoplasms; Cecal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced

Study Officials

• Joel Baumgartner

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery

Model Details: Unblinded, randomized 2:1 to CRS-HIPEC + LSTA1 vs. CRS-HIPEC alone

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 22, 2024
• Study Start: November 30, 2023
• Primary Completion: June 24, 2024
• Study Completion: June 24, 2024
• Last Updated: August 20, 2024

Record last verified: 2024-08

Locations

US (1)