Study on HST-1011 Alone and with an Anti-PD1 Antibody for Advanced Solid Tumors

Sponsor: HotSpot Therapeutics, Inc

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05662397

Provider View

This clinical trial is testing a new drug, HST-1011, both by itself and in combination with another drug, to see if it can help treat advanced solid tumors in patients who have not responded to other treatments.

Patient Parameters

Program Overview

This study is exploring a new treatment called HST-1011 for patients with advanced solid tumors that have not responded to standard treatments, including anti-PD(L)1 therapies. The study is divided into two phases. In Phase 1, patients will receive HST-1011 either alone or with an anti-PD1 antibody called cemiplimab. Phase 2 will look at how well HST-1011 works in combination with other treatments to fight tumors.

Description

This clinical trial is investigating a new drug, HST-1011, for treating advanced solid tumors in patients who have not responded to other treatments. The study is divided into two phases:

  • Phase 1: Patients will receive HST-1011 either by itself (Parts A1 and A2) or with an anti-PD1 antibody called cemiplimab (Part B). In Part A1, patients will receive increasing doses of HST-1011 to find the best dose. Part A2 will optimize this dose. Part B will test HST-1011 with cemiplimab, possibly starting before Part A1 is finished.

  • Phase 2: This phase will evaluate how well HST-1011 works in combination with anti-PD(L)1 antibodies or other standard treatments to reduce tumors.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Able to understand and follow study requirements.
  • Must sign a consent form.
  • Have a confirmed advanced solid tumor that is metastatic, recurrent, or cannot be removed by surgery, including:
    • Tumors that have not responded to anti-PD(L)1 treatments
    • Platinum-resistant ovarian cancer
    • Anal cancer
    • Rectal cancer
    • Castration-resistant prostate cancer
  • Have tried and not responded to standard treatments for their cancer.
  • Have at least one measurable tumor outside the brain.
  • Agree to provide tumor samples before and during treatment.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.

Exclusion Criteria

  • Have an active autoimmune disease or need long-term steroid treatment.
  • Cannot tolerate anti-PD(L)1 antibody (for Part B only).
  • Have participated in a study with a CBL-B inhibitor before.
  • Have untreated or symptomatic cancer spread to the brain.
  • Are taking medications that could interact with HST-1011.
  • Have a history of digestive issues affecting drug absorption or cannot take oral medications.
  • Have an active infection needing treatment.
  • Have a known or suspected COVID-19 infection.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.