ADCE-T02 for Solid Tumors

Recruiting at 6 trial locations

Overseen By Pei Yee Wee

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Multitude Therapeutics Inc.

Disqualifiers: CNS metastasis, Cardiac disease, ILD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 24 months

66 Participants Needed

Trial Summary

What is the purpose of this trial?

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 conjugate which may be used in the future as a possible treatment for advanced solid tumors. The main purpose of the study is to determine the Maximum Tolerated Dose (MTD), the recommended dose and the safety and tolerability of ADCE-T02 when given as a single therapy over a range of different dose levels.

Eligibility Criteria

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: ADCE-T02 Dose Escalation Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Multitude Therapeutics Inc.

Lead Sponsor

Trials

6

Recruited

440+

Adcendo ApS

Lead Sponsor

Trials

2

Recruited

340+