210 Participants Needed

ADCE-T02 for Solid Tumors

Recruiting at 10 trial locations
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MM
PY
SB
Overseen BySarah Berardini
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Multitude Therapeutics Inc.
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 explores a new treatment called ADCE-T02 to determine its potential benefits for people with advanced solid tumors. The goal is to identify the safest and most effective dose of ADCE-T02 when used alone. The trial targets individuals whose tumors cannot be surgically removed, have worsened after at least one other treatment, and have a life expectancy of at least three months. 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 information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that ADCE-T02 is likely to be safe for humans?

Research has shown that ADCE-T02 effectively targets tumors in various lab models. Notably, studies with animals found the experimental drug well tolerated, suggesting potential safety, though its effects in humans remain under investigation. As a phase 1 trial, the primary goal is to determine the safe dosage for humans and identify any side effects. Currently, clear information on side effects in humans is unavailable, but this trial aims to provide further insights.12345

Why do researchers think this study treatment might be promising?

Unlike standard treatments for solid tumors, which often involve chemotherapy or radiation, ADCE-T02 is unique because it targets cancer cells differently. This treatment uses a novel mechanism of action, potentially enhancing its ability to specifically target and kill tumor cells while sparing healthy tissue. Researchers are excited about ADCE-T02 because it could reduce side effects commonly associated with traditional cancer therapies, offering patients a more tolerable and possibly more effective treatment option.

What evidence suggests that ADCE-T02 might be an effective treatment for solid tumors?

Research has shown that ADCE-T02, the investigational treatment in this trial, effectively fights various solid tumors. It targets tumors with both high and low levels of a protein called tissue factor, commonly present in many cancers. In animal studies, ADCE-T02 proved safe and did not cause harmful side effects. These encouraging results suggest it could be a potential treatment for advanced solid tumors.14567

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors, including uterine tumors, who've had at least one systemic therapy but are still progressing. They must have a measurable lesion, be relatively fit (ECOG 0-1), expected to live more than 3 months, and have good organ function. Women of childbearing age and men must agree to use contraception during the study.

Inclusion Criteria

My cancer is advanced and cannot be removed by surgery.
My condition worsened after at least one treatment.
I am fully active or can carry out light work.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ADCE-T02 to determine the Maximum Tolerated Dose (MTD) and safety profile

Up to 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • ADCE-T02
Trial Overview The trial is testing ADCE-T02 as a potential treatment for advanced solid tumors. It's in phase 1 to find out the highest dose patients can take without serious side effects (MTD) and how safe it is across different doses when given alone.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: ADCE-T02 Dose Escalation followed by an Expansion PhaseExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Multitude Therapeutics Inc.

Lead Sponsor

Trials
6
Recruited
440+

Adcendo ApS

Lead Sponsor

Trials
2
Recruited
340+

Citations

Study Details | NCT06597721 | ADCE-T02, a Tissue Factor ...Adcendo ApS is conducting a phase 1 study of an investigational drug called ADCE-T02 (previously known as AMT-754), a tissue factor targeted antibody-drug ...
PipelineADCE-T02 has demonstrated strong anti-tumor activity in in vivo studies across a range of solid tumors with both high and low TF expression as well as ...
Adcendo ApS to Present Data on its Clinical Stage ADCs ...ADCE-T02 shows strong anti-tumor activity in a wide range of solid tumor models and is well tolerated in non-human primate toxicology studies ...
FDA Clears IND for Phase 1 Trial of ADCE-T02 in Solid ...The FDA has granted clearance to an IND application for a phase 1 trial evaluating ADCE-T02, a potential first-in-class ADC, in advanced solid tumor treatment.
ADCE-T02 ADC against tissue factor shows strong ...In vivo, ADCE-T02 showed potent antitumoral efficacy ... A phase I clinical trial for ADCE-T02 in patients with advanced solid tumors is ongoing ( ...
Abstract 4778: ADCE-T02: A first-in-class topoisomerase-1 ...In vivo, ADCE-T02 shows strong anti-tumor activity in a wide range of solid tumor models including pancreatic cancer, esophageal squamous cell ...
Adcendo ApS to Present Data on its Clinical Stage ADCs ...ADCE-T02 shows strong anti-tumor activity in a wide range of solid tumor models and is well tolerated in non-human primate toxicology studies ...
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