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CBL-B Inhibitor

HST-1011 + Anti-PD1 Antibody for Advanced Cancer

Phase 1 & 2

Recruiting

Research Sponsored by HotSpot Therapeutics, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial tests a new drug to treat advanced cancer that hasn't responded to existing treatments.

Who is the study for?

This trial is for adults with advanced solid tumors who have not responded to anti-PD(L)1 therapies or other standard treatments. Participants must be able to undergo biopsies, understand the study requirements, and have at least one measurable tumor lesion. They cannot join if they have active infections, untreated brain metastases, conditions affecting drug absorption, suspected COVID-19 infection, or are on medications that could interact with HST-1011.Check my eligibility

What is being tested?

The study tests HST-1011 alone and combined with Cemiplimab in patients whose solid tumors didn't improve after anti-PD(L)1 therapy or standard care. It's a Phase 1/2 trial aiming to find out how safe and effective these treatments are when others fail.See study design

What are the potential side effects?

Potential side effects of HST-1011 and Cemiplimab may include immune system reactions leading to inflammation in various organs, infusion-related responses like fever or chills, fatigue from treatment burden, gastrointestinal disturbances due to oral medication intake issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Determine the Recommended Phase 2 Dose (RP2D) and schedule of HST-1011 monotherapy in Part A2.

Evaluate the safety and tolerability of escalating doses of single-agent HST-1011 in Part A1 or in combination with cemiplimab in Part B.

Secondary outcome measures

Characterize global gene expression profiles following HST-1011 monotherapy Part A1 and Part A2, or in combination with cemiplimab in Part B.

Characterize the concentration of peripheral blood cytokines/chemokines following HST-1011 monotherapy Part A1 and Part A2, or in combination with cemiplimab in Part B.

Disease Control Rate (DCR) of single-agent HST-1011 in Part A2.

+8 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: HST-1011 Monotherapy Dose Optimization (Part A2)Experimental Treatment1 Intervention

Evaluation of HST-1011 monotherapy dose/dose regimen.

Group II: HST-1011 Monotherapy Dose Escalation (Part A1)Experimental Treatment1 Intervention

Multiple dose levels of HST-1011 to be evaluated.

Group III: HST-1011 Dose Escalation in Combination with cemiplimab (Part B)Experimental Treatment2 Interventions

Multiple dose levels of HST-1011 to be evaluated in combination with cemiplimab.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cemiplimab

2015

Completed Phase 3

~1340

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

HotSpot Therapeutics, IncLead Sponsor

Amanda Redig, MD, PhDStudy DirectorHotSpot Therapeutics

Media Library

HST-1011 (CBL-B Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05662397 — Phase 1 & 2

Solid Tumors Research Study Groups: HST-1011 Monotherapy Dose Escalation (Part A1), HST-1011 Monotherapy Dose Optimization (Part A2), HST-1011 Dose Escalation in Combination with cemiplimab (Part B)

Solid Tumors Clinical Trial 2023: HST-1011 Highlights & Side Effects. Trial Name: NCT05662397 — Phase 1 & 2

HST-1011 (CBL-B Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05662397 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the cap on total participants in this clinical experiment?

"Affirmative. Clinicaltrials.gov provides evidence that this experiment, first posted on March 15th 2023 and recently updated on April 13th 2023 is actively recruiting participants. 203 individuals are expected to join the trial from 4 separate locations."

Answered by AI

How many research facilities are conducting this trial?

"This clinical research is accepting patients at 4 distinct sites, which are located in Portland, Pittsburgh and Houston plus an additional four locations. To minimize travel needs, participants should select the clinic closest to them when enrolling."

Answered by AI

Are there any current opportunities to partake in this investigation?

"Affirmative. According to clinicaltrials.gov, this medical trial is actively enrolling patients since it was first posted on March 15th 2023 and newly updated April 13th 2023. A total of 203 participants are sought from 4 different sites."

Answered by AI

What are the objectives of this clinical investigation?

"The primary objective of the clinical trial, which is to be assessed over a one-year period, will be determining the suggested dosage and timing of HST-1011 monotherapy in Part A2. Secondary aims include gauging overall response rate following either single or combined therapies (Part A1/A2), characterizing gene expression profiles after these interventions, and measuring duration of response for single course therapy (Part A2)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of HST-1011 Given as Monotherapy and in Combination With an Anti-PD1 Antibody

2023. "A Study of HST-1011 Given as Monotherapy and in Combination With an Anti-PD1 Antibody". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05662397.