ADCE-B05 for Cancer

Not yet recruiting at 6 trial locations
MM
CL
Overseen ByCharlotte Lybek Lind
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 cancer treatment called ADCE-B05 to determine its safe dosage and potential side effects. It targets individuals with advanced solid tumors that have spread or cannot be surgically removed, who have not responded to other treatments. Participants must have a condition that worsens despite previous therapies. The treatment involves receiving ADCE-B05 intravenously every three weeks. The trial excludes those who recently underwent cancer treatments or have untreated brain-related cancer issues. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications to join the trial?

The trial requires that you stop any systemic anticancer therapy, including investigational agents, at least 3 weeks or 5 half-lives before starting the study treatment. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

Is there any evidence suggesting that ADCE-B05 is likely to be safe for humans?

Research has shown that ADCE-B05 remains in the early stages of testing to determine its safety for humans. The primary goal is to establish the maximum safe dosage. Currently, studies have not provided enough information to assess its tolerability or identify common side effects. As this is an early trial, the treatment's safety is not yet fully understood. Participants will receive varying doses to identify what is both effective and safe.12345

Why do researchers think this study treatment might be promising?

ADCE-B05 is unique because it introduces a novel approach for treating cancer, focusing on dose escalation followed by a dose expansion phase. Unlike standard chemotherapy, which typically targets rapidly dividing cells non-specifically, ADCE-B05 is designed to be administered intravenously on a three-week cycle, potentially allowing for more precise targeting of cancer cells. Researchers are excited about ADCE-B05 because it offers a new mechanism of action that could enhance effectiveness while potentially reducing side effects, compared to existing treatments. This innovative treatment approach generates hope for improved outcomes in cancer therapy.

What evidence suggests that ADCE-B05 might be an effective treatment for cancer?

Research shows that ADCE-B05, the treatment under study in this trial, could be a promising cancer treatment. Early animal studies demonstrated its effectiveness in fighting cancer cells. The treatment was generally well-tolerated in these tests, causing few side effects. Although limited information exists from human studies, these early results suggest that ADCE-B05 could benefit cancer patients and warrants further research.12346

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors that can't be surgically removed or have spread, and who haven't responded to other treatments. They must have measurable disease progression, be relatively healthy (ECOG status 0 or 1), and have good blood work results. Men must use barrier contraception during the study and for 4 months after; women not of childbearing potential or those agreeing to contraception guidelines can join.

Inclusion Criteria

I am not pregnant or breastfeeding, and if I can have children, I agree to use contraception as advised.
My cancer is advanced, cannot be surgically removed, and does not respond to current treatments.
My cancer has worsened despite recent treatment.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive ADCE-B05 intravenously on a 3 weekly dosing cycle to determine the Maximum Tolerated Dose (MTD)

11 months

Dose Expansion

Participants receive ADCE-B05 at the Recommended Expansion Dose to further assess safety and antitumor activity

7 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • ADCE-B05

Trial Overview

The trial is testing ADCE-B05, a new therapy for solid tumors. It aims to find the highest dose patients can tolerate without severe side effects (MTD), suggest a dose for future studies (Recommended Expansion Dose), and assess overall safety at different doses when given alone.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: ADCE-B05Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Adcendo ApS

Lead Sponsor

Trials
2
Recruited
340+

Citations

First-in-Human Study of ADCE-B05 in Patients With ...

The main purpose of the study is to determine the Maximum Tolerated Dose (MTD), the Recommended Expansion Dose and the safety and tolerability ...

Pipeline

Preclinical studies have demonstrated strong anti-tumor activity across a range of in vivo models, as well as a highly encouraging toxicology profile, ...

ADCE-B05 for Cancer · Info for Participants

The trial is testing ADCE-B05, a new therapy for solid tumors. It aims to find the highest dose patients can tolerate without severe side ...

Follow the Money: First-in-Class ADCs for Underserved ...

This innovative approach holds significant potential for developing first-in-class and best-in-class therapeutics in oncology, autoimmune ...

ANZCTR search results | Australian Clinical ...

First-in-Human Study of ADCE-B05 in Patients With Advanced Solid Tumors. The main purpose of the study is to determine the Maximum Tolerated Dose (MTD), the ...

Clinical Trial: First-in-Human Study of ADCE-B05 in ...

Brief Summary: The main purpose of the study is to determine the Maximum Tolerated Dose (MTD), the Recommended Expansion Dose and the safety and ...