ADCE-D01 for Soft Tissue Sarcoma

(ADCElerate1 Trial)

Recruiting at 8 trial locations

Overseen By Margaret McNaull

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Adcendo ApS

Must not be taking: Investigational agents

Disqualifiers: Brain malignancy, Cardiovascular disease, HIV, others

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

Compensation: Varies

Number of Visits: Unknown

270 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn about the safety, tolerability and efficacy of ADCE-D01.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have had any systemic anticancer therapy, including investigational agents, within 4 weeks before starting the study treatment.

What data supports the effectiveness of the drug ADCE-D01 for treating soft tissue sarcoma?

Some studies suggest that adjuvant chemotherapy (additional treatment given after the main treatment) can help improve survival rates and reduce the chance of cancer returning in patients with soft tissue sarcoma. However, the evidence is mixed, and the benefits seem to be modest, with some studies showing a 5% to 10% improvement in survival and relapse rates. ^{1 2 3 4 5}

How is the drug ADCE-D01 different from other treatments for soft tissue sarcoma?

ADCE-D01 may offer a novel approach compared to traditional treatments, as current options like adjuvant chemotherapy have shown conflicting results and are not standard for soft tissue sarcoma. The uniqueness of ADCE-D01 could lie in its specific mechanism of action or its potential to improve local control and survival rates, which are areas where existing treatments have limitations. ^{1 2 6 7 8}

Eligibility Criteria

This trial is for adults over 18 with soft tissue sarcoma that can't be removed by surgery and has spread. They should have tried at least one, but no more than two, previous cancer treatments. Participants need to be fairly active (ECOG status of 0 or 1) and expected to live at least three months. Women must not be pregnant or breastfeeding and either not able to become pregnant or follow strict birth control guidelines. Men must use barrier contraception.

Inclusion Criteria

I've had 1-2 treatments for cancer that can't be removed by surgery.

I am fully active or restricted in physically strenuous activity but can do light work.

My doctor expects me to live at least 3 more months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation and Expansion

Participants receive ADCE-D01 to evaluate safety, pharmacokinetics, and antitumor activity

18 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• ADCE-D01

Trial Overview The study is testing ADCE-D01, an antibody-drug conjugate (ADC), which is a targeted cancer therapy designed to deliver chemotherapy directly to the tumor cells in patients with soft tissue sarcoma. The focus is on its safety, how well it's tolerated by patients, and its effectiveness against the cancer.

Participant Groups

Group I: ADCE-D01 Experimental Treatment 1 Intervention

ADCE-D01

Who Is Running the Clinical Trial?

Adcendo ApS

Lead Sponsor

Trials

2

Recruited

340+

References

1. United States pubmed.ncbi.nlm.nih.gov

Adjuvant chemotherapy for adult soft tissue sarcomas of the extremities and girdles: results of the Italian randomized cooperative trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Adjuvant chemotherapy for soft tissue sarcoma. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Adjuvant chemotherapy with doxorubicin, ifosfamide, and lenograstim for resected soft-tissue sarcoma (EORTC 62931): a multicentre randomised controlled trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

A randomized trial for the treatment of high-grade soft-tissue sarcomas of the extremities: preliminary observations. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

The reason for confining the use of adjuvant chemotherapy in soft tissue sarcoma to the investigational setting. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Adjuvant therapy for adult patients with soft tissue sarcomas. [2006]

7. England pubmed.ncbi.nlm.nih.gov

Prognosis in high-grade soft tissue sarcomas. The Scandinavian Sarcoma Group experience in a randomized adjuvant chemotherapy trial. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Expression of HER1/EGFR protein in human soft tissue sarcomas. [2022]