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Clinical Trials in Sweden / NCT05838768
Active, not recruiting Phase 1

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

NCT05838768 · tracked via the Priya Life Science Sweden tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 1
Started
2023-06-27
Last updated
2026-03-24

Condition(s) studied

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

Investigational drug(s) / intervention(s)

HRO761pembrolizumab →irinotecan →

HRO761: Tablet

pembrolizumab: Concentrate for solution for infusion

irinotecan: Concentrate for solution for infusion

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
Key Inclusion criteria: * Patients with advanced unresectable or metastatic MSIhi or MMR deficient (dMMR) solid tumors who have progressed after or are intolerant to prior standard therapy. * 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. * 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. * Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1 * Measurable disease as determined by RECIST version 1.1 * • All patients (Arm A, B and C) will have available archival tumor tissue obtained prior to study treatment initiation, to allow retrospective MSIhi/dMMR status confirmation. A newly obtained biopsy will only be collected at screening if there is no archival tumor tissue available and if safe and medically feasible according to treating institution's guidelines. Exceptions may be considered after documented discussion with Novartis. Key Exclusion criteria: * Impaired cardiac function or clinically significant cardiac disease * Clinically significant eye impairment * Patients with a primary Central Nervous System (CNS) tumor or tumor metastatic to the CNS * Human Immunodeficiency Virus (HIV) infection * Active Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Tuberculosis infection. Patients whose disease is controlled under antiviral therapy should not be excluded. * History of severe hypersensitivity reactions to any ingredient of study drug(s) * 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. Other protocol-defined inclusion/exclusion criteria may apply

Primary outcome measure(s)

  • Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) — at month 36
    Month 36 is assumed to be study end. Incidence and severity of AEs and SAEs by treatment group, including changes in vital signs, electrocardiograms (ECGs) and laboratory results qualifying and reported as AEs.
  • Incidence of dose limiting toxicities (DLTs) of treatment (Escalation only) — at Day 28
    A DLT is defined as an adverse event or abnormal laboratory value that is not primarily related to disease, disease progression, intercurrent illness/injury, or concomitant medications that occurs within the first 28 days of study treatment and meets a defined criteria.
  • Frequency of dose interuptions as a measure of tolerability — at month 36
    Month 36 is assumed to be study end Number of dose interruptions by treatment group/arm as a measure of tolerability.
  • Frequency of dose discontinuations as a measure of tolerability — at month 36
    Month 36 is assumed to be study end Number of dose discontinuations by treatment group/arm as a measure of tolerability.
  • Frequency of dose reductions as a measure of tolerability — at month 36
    Month 36 is assumed to be study end Number of dose reductions by treatment group/arm as a measure of tolerability.

Trial sites (28)

FacilityCityRegionStatus
University of California LA Los Angeles California
UCSF San Francisco California
Dana Farber Cancer Institute Boston Massachusetts
Memorial Sloan Kettering New York New York
Columbia University Medical Ctr New York New York
Univ of TX MD Anderson Cancer Cntr Houston Texas
Novartis Investigative Site Brussels Belgium
Novartis Investigative Site Beijing China
Novartis Investigative Site Guangzhou China
Novartis Investigative Site Bordeaux France
Novartis Investigative Site Marseille France
Novartis Investigative Site Toulouse France
Novartis Investigative Site Essen Germany
Novartis Investigative Site Tel Aviv Israel
Novartis Investigative Site Milan MI
Novartis Investigative Site Rozzano MI
Novartis Investigative Site Kashiwa Chiba
Novartis Investigative Site Oslo Norway
Novartis Investigative Site Singapore Singapore
Novartis Investigative Site Seoul South Korea
Novartis Investigative Site Barcelona Spain
Novartis Investigative Site Madrid Spain
Novartis Investigative Site Madrid Spain
Novartis Investigative Site Valencia Spain
Novartis Investigative Site Stockholm Sweden
Novartis Investigative Site Taipei Taiwan
Novartis Investigative Site London United Kingdom
Novartis Investigative Site Oxford United Kingdom

On this site

📄 Keytruda (pembrolizumab) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05838768 on ClinicalTrials.gov ↗ ← All trials in Sweden