ADCT-901 for Solid Tumors

No longer recruiting at 12 trial locations

Overseen By Contact ADC Therapeutics

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: ADC Therapeutics S.A.

Must not be taking: Experimental medications

Disqualifiers: Active infection, CNS metastases, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the optimal dose and assess the safety of a new treatment called ADCT-901 for individuals with certain advanced solid tumors. Participants will receive this treatment either in increasing doses or at a dose deemed safe from earlier testing. The trial suits those with conditions such as cholangiocarcinoma, ovarian cancer, prostate cancer, renal cell carcinoma, or triple-negative breast cancer, who have not responded to standard treatments. 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 it.

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

The trial information does not specify if you need to stop taking your current medications. However, you cannot use any other experimental medication within 14 days before starting the study drug.

Is there any evidence suggesting that ADCT-901 is likely to be safe for humans?

Research shows that ADCT-901 is being tested for safety and patient tolerance in those with advanced solid tumors. Early studies aim to find the optimal dose by checking for serious side effects and observing patient responses to various doses.

Since ADCT-901 is in its first testing phase, researchers are still learning about its safety in humans. This phase focuses on ensuring the drug's safety and determining the correct dose.

Prospective participants should know that this stage seeks to understand treatment tolerance and identify any issues early. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

ADCT-901 is unique because it represents a next-generation approach to targeting solid tumors. Unlike traditional chemotherapy that attacks both healthy and cancerous cells indiscriminately, ADCT-901 is designed to specifically target cancer cells, potentially reducing harmful side effects. It works by delivering a toxic payload directly to the cancer cells, sparing healthy ones, which could lead to more effective treatments with fewer adverse effects. Researchers are excited about its potential to improve outcomes for patients with advanced solid tumors, as it offers a more precise method of cancer treatment.

What evidence suggests that ADCT-901 might be an effective treatment for solid tumors?

Research has shown that ADCT-901 might help treat advanced solid tumors by targeting a protein called KAAG1, often found in these tumors. The trial will evaluate ADCT-901 in two parts: Part 1 involves dose escalation to determine the optimal dose, and Part 2 involves dose expansion to further assess its effectiveness. Early results suggest it can shrink or control tumor growth, making it a promising option, especially for conditions like ovarian cancer that don't respond to standard treatments. Although these findings are encouraging, more research is needed to confirm its effectiveness. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults with certain advanced solid tumors (like cholangiocarcinoma, ovarian, prostate cancer, renal cell carcinoma, and TNBC) that are measurable and have not responded to or can't tolerate current treatments. Participants should not have active severe diarrhea or eye diseases, recent serious infections requiring IV treatment, symptomatic brain metastases or leptomeningeal disease.

Inclusion Criteria

My current treatment isn't working or causes severe side effects.

My cancer has spread to my bones, but it can be measured by scans.

I have prostate cancer with bone metastases and a PSA level of 2.0 ng/mL or higher.

Exclusion Criteria

I have severe or chronic diarrhea.

I have mild eye conditions but not an active eye disease.

I do not have any significant eye diseases or history of severe conjunctivitis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of ADCT-901 as monotherapy until disease progression, adverse event, or other discontinuation criteria

Variable

Dose Expansion

Participants receive ADCT-901 monotherapy at the dose identified as the RP2D/MTD in Part 1 until disease progression, adverse event, or other discontinuation criteria

Variable

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 2.5 years

What Are the Treatments Tested in This Trial?

Interventions

• ADCT-901

Trial Overview The study tests ADCT-901's safety and tolerability to find the right dose for phase 2 trials. It aims to see how participants' bodies handle the drug (pharmacokinetics) and its effectiveness against selected solid tumors at different doses.

How Is the Trial Designed?

Group I: Part 2: Dose Expansion Experimental Treatment 1 Intervention

In Part 2 (dose expansion), participants will receive ADCT-901 monotherapy at the dose identified as the RP2D/MTD in Part 1 (dose escalation). Participants will be split into two groups: Group 1: An indication for which ADCT-901 showed in Part 1 to have preliminary activity. Group 2: A group of participants with Part 1 indications, except for the one selected in Group 1 of Part 2. No more than 30% of participants with the same indication are allowed in this basket group. Participants can receive ADCT-901 until disease progression, AE, or other discontinuation criteria, whichever occurs first.

Group II: Part 1: Dose Escalation Experimental Treatment 1 Intervention

In Part 1 (dose escalation) participants with selected advanced solid tumors will receive escalating doses of ADCT-901 as monotherapy. Participants can receive ADCT-901 until disease progression, adverse event (AE), or other discontinuation criteria, whichever occurs first.

Who Is Running the Clinical Trial?

ADC Therapeutics S.A.

Lead Sponsor

Trials

32

Recruited

2,700+

Citations

1. adctmedical.com adctmedical.com/wp-content/uploads/2022/06/ASCO_2022_Harvey_ADCT-901_TIP_poster_FINAL.pdf

KEY MESSAGE A study to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of ADCT-901 in selected advanced solid tumors.

2. adctherapeutics.com adctherapeutics.com/our-pipeline1-1/adct-901/

ADCT-901 ADCT-901 is being developed for the treatment of advanced solid tumors with high unmet medical needs, including platinum resistant ovarian cancer and triple ...

3. swissbiotech.org swissbiotech.org/listing/adc-therapeutics-doses-first-patient-in-phase-1-clinical-trial-of-adct-901-in-advanced-solid-tumors/

ADC Therapeutics starts clinical trial of antitumor drug ... The open-label, dose-escalation and dose-expansion clinical trial will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of ADCT-901 ...

4. ir.adctherapeutics.com ir.adctherapeutics.com/press-releases/press-release-details/2021/ADC-Therapeutics-Doses-First-Patient-in-Phase-1-Clinical-Trial-of-ADCT-901-in-Advanced-Solid-Tumors/default.aspx

ADC Therapeutics Doses First Patient in Phase 1 Clinical ... ADC Therapeutics Doses First Patient in Phase 1 Clinical Trial of ADCT-901 in Advanced Solid Tumors. September 27, 2021. ADCT-901 targets KAAG1, ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06219941

Study Details | NCT06219941 | AZD0901 in Participants ... The purpose of this study is to assess the safety, tolerability, efficacy, pharmacokinetics (PK), and immunogenicity of AZD0901 as monotherapy and in ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04972981

NCT04972981 | A Study to Evaluate the Safety, Tolerability ... A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ADCT-901 in Participants With Selected Advanced Solid Tumors.

7. ascopubs.org ascopubs.org/doi/abs/10.1200/JCO.2022.40.16_suppl.TPS3157

First-in-human, phase 1, open-label, dose-escalation, ... This study aims to identify the recommended dose and schedule for expansion and to characterize safety and tolerability of ADCT-901 in patients ...

8. clin.larvol.com clin.larvol.com/trial-detail/NCT04972981

Businesswire 2021 - ADC Therapeutics Doses ... A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ADCT-901 in Participants With Selected Advanced Solid Tumors. P1.

9. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2021-10797

A Study to Evaluate the Safety, Tolerability ... A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ADCT-901 in Participants With Selected Advanced Solid Tumors.