CLIO-8221 for Cancer

Not yet recruiting at 9 trial locations
C
Overseen ByCMO
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, CLIO-8221, for individuals with advanced solid tumors. The goal is to determine the optimal dose that patients can tolerate and assess its effectiveness in treating specific tumor types. This trial might suit those with cancer that cannot be treated with surgery and who have already tried other therapies. Participants should have reasonable heart function and be able to carry on daily activities with minimal limitation. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that CLIO-8221 is likely to be safe for humans?

Research shows that CLIO-8221 is undergoing safety testing for treating advanced solid tumors. Initial studies aim to find the highest dose patients can tolerate without severe side effects, ensuring patient safety.

Previous research highlights safety as a major focus. Scientists work diligently to understand the treatment's effects and minimize risks. As a Phase 1 and Phase 2 trial, the treatment remains under close study to ensure safety before wider use. This phase is crucial for assessing how the body handles the drug and identifying possible side effects.

The process involves gradually increasing doses to determine safe and effective levels. Although detailed safety data is not yet available, the trial's design demonstrates a careful approach to understanding and managing risks associated with CLIO-8221.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about CLIO-8221 because it introduces a novel approach to cancer treatment. Unlike traditional chemotherapy or targeted therapies that attack cancer cells in specific ways, CLIO-8221 is being tested for its potential to work across a range of tumor types by escalating doses to find the most effective one. This drug's unique mechanism could provide more personalized and potentially more effective treatment options for patients, especially in its ability to be fine-tuned for different tumors. If successful, this could change the way we approach cancer treatment by offering a more adaptable therapy that targets cancer more precisely.

What evidence suggests that CLIO-8221 might be an effective treatment for cancer?

Research has shown that CLIO-8221 is a promising treatment for certain cancers, particularly those with lower levels of the protein HER2. This medicine is designed to target cancer cells more effectively than some current treatments. Studies have found that CLIO-8221 can significantly shrink tumors, even when other treatments, such as T-DXd, have failed. This suggests it might be effective when other treatments do not work. Early results are positive, but further research is needed to confirm its effectiveness across different cancer types. Participants in this trial will receive CLIO-8221 in a dose escalation and dose level expansion format to further evaluate its effectiveness.13456

Are You a Good Fit for This Trial?

This trial is for patients with advanced solid tumors that have spread or can't be surgically removed. They should have tried other treatments unless they're not suitable, unwilling, or unable to access them. Participants need a heart function score (LVEF) of at least 50% and must be relatively active and able to care for themselves.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.
I have an advanced solid tumor.
My cancer cannot be removed by surgery and I've tried all beneficial treatments available to me.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Dose-escalation and Dose Level Expansion

CLIO-8221 monotherapy in escalating doses to determine the maximum tolerated dose and/or recommended dose for expansion

Up to 2 years

Phase 2: Tumor-Specific Expansions with Dose Optimization

Further evaluation of CLIO-8221 in tumor-specific expansion cohorts to optimize dosing and assess preliminary efficacy

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • CLIO-8221

Trial Overview

The study tests CLIO-8221 in two phases: Phase 1 finds the highest dose patients can tolerate without severe side effects; Phase 2 optimizes dosing in specific tumor types and checks how well the drug works.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Dose escalation and dose level expansionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Callio Therapeutics

Lead Sponsor

Citations

Study in Advanced Solid Tumor Patients

Phase 2 will further evaluate CLIO-8221 in tumor-specific expansion cohorts to optimize dosing and assess preliminary efficacy. Safety, ...

Dual-payload ADCs move into first oncology clinical trials

One opportunity for CLIO-8221 is in cancers with lower HER2-expression levels, which don't typically respond as well to HER2-targeted ADCs.

CLIO-8221 for Cancer · Info for Participants

The study tests CLIO-8221 in two phases: Phase 1 finds the highest dose patients can tolerate without severe side effects; Phase 2 optimizes dosing in specific ...

Dual-Target ADC Achieves “1+1>2” Synergistic Killing

Callio's CLIO-8221 (HER2-targeting, Topo1i+ATRi DAR4+4) achieves effective tumor regression with a single dose in T-DXd resistant models, with ...

Dual Payload ADCs-Ushering in a New Wave

Callio Therapeutics' HER2-targeting dual payload ADC CLIO-8221 (HMBD-802) embodies this strategy, with a 4+4 DAR combination of TOP1 and ATR ...

Study in Advanced Solid Tumor Patients - ClinicalTrials.Veeva

Phase 1: CLIO-8221 monotherapy in escalating doses. Phase 2: Phase 2 will be initiated in tumor-specific expansion cohorts at selected doses.