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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - 100 Years

Healthy Volunteers

Not accepted

Interventions

• HRO761 — DRUG
  Tablet
• pembrolizumab — BIOLOGICAL
  Concentrate for solution for infusion
• irinotecan — DRUG
  Concentrate for solution for infusion

Study Details

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.

Key Dates

Start date

Jun 27, 2023

Status verified

Mar 2026

Primary completion

Aug 31, 2027

Completion

Aug 31, 2027

Study Design

Enrollment

123 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: A: HRO761 single agent
  phase Ib (Dose finding (Escalation and Optimization) and expansion)
• Experimental: B: HRO761 + pembrolizumab
  phase Ib (Dose escalation and expansion)
• Experimental: C: HRO761 + irinotecan
  phase Ib (Dose escalation and expansion)

Primary Outcome Measure

Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: at month 36 ]

Locations (6)

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