RECRUITING

Study of HRO761 Alone or in Combination in Cancer Patients With Specific DNA Alterations Called Microsatellite Instability or Mismatch Repair Deficiency.

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The main purpose of the study is to evaluate the safety and tolerability of HRO761 and identify the recommended dose(s), i.e., the optimal safe and active dose of HRO761 alone or in combination with pembrolizumab or irinotecan that can be given to patients who have cancers with specific molecular alterations called MSIhi (Microsatellite Instability-high) or dMMR (Mismatch Repair Deficient) that might work best to treat these specific cancer types and to understand how well HRO761 is able to treat those cancers.

Official Title

An Open-label, Multi-center Phase I/Ib Dose Finding and Expansion Study of HRO761 as Single Agent and in Combinations in Patients With Microsatellite Instability-High or Mismatch Repair Deficient Advanced Solid Tumors.

Quick Facts

Study Start:2023-06-27
Study Completion:2030-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05838768

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients with advanced unresectable or metastatic MSIhi or MMR deficient (dMMR) solid tumors who have progressed after or are intolerant to prior standard therapy.
  2. * Arm A and C: Patients must have progressed on the most recent therapy for advanced disease including one prior line of immune checkpoint inhibitor therapy.
  3. * Arm B: Patients should have received prior chemotherapy or targeted therapy, and patients should have received prior immune checkpoint inhibitor or should be expected to benefit from immune checkpoint inhibitor therapy.
  4. * Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
  5. * Measurable disease as determined by RECIST version 1.1
  6. * HRO761 s.a. (Arm A) dose finding only: Patients must have a site of disease amenable to biopsy and be a candidate for tumor biopsy according to the treating institution's guidelines. Patients must be willing to undergo a new tumor biopsy at screening, and during therapy on the study. A biopsy from the same lesion is preferred if safe and medically feasible. Exceptions may be considered after documented discussion with Novartis.
  7. * All patients (Arm A, B and C) will have available archival tumor tissue obtained prior to study treatment initiation (in addition to newly obtained tumor biopsy at screening for Arm A), to allow retrospective MSIhi/dMMR status confirmation.
  1. * Impaired cardiac function or clinically significant cardiac disease
  2. * Clinically significant eye impairment
  3. * Patients with a primary Central Nervous System (CNS) tumor or tumor metastatic to the CNS
  4. * Human Immunodeficiency Virus (HIV) infection
  5. * Active Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Tuberculosis infection. Patients whose disease is controlled under antiviral therapy should not be excluded.
  6. * History of severe hypersensitivity reactions to any ingredient of study drug(s)
  7. * Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs (e.g., severe ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection), except for prior gastrectomy.

Contacts and Locations

Study Contact

Novartis Pharmaceuticals
CONTACT
1-888-669-6682
novartis.email@novartis.com
Novartis Pharmaceuticals
CONTACT
+41613241111

Study Locations (Sites)

University Of California LA Dept of Onc
Los Angeles, California, 90095
United States
UCSF
San Francisco, California, 94115
United States
Memorial Sloan Kettering Dept. of MSKCC
New York, New York, 10017
United States
Columbia University Medical Ctr .
New York, New York, 10032
United States
Univ of TX MD Anderson Cancer Cntr Primary
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-27
Study Completion Date2030-01-31

Study Record Updates

Study Start Date2023-06-27
Study Completion Date2030-01-31

Terms related to this study

Keywords Provided by Researchers

  • Phase I/Ib
  • MSIhi (Microsatellite Instability-High)
  • dMMR (Mismatch Repair Deficient)
  • solid tumors
  • CRC (Colorectal cancer)
  • advanced cancer
  • metastatic
  • HRO761
  • pembrolizumab
  • irinotecan

Additional Relevant MeSH Terms

  • MSIhi or dMMR Advanced Unresectable or Metastatic Solid Tumors, Including Colorectal Cancers