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Anti-metabolites

ADCT-601 + Gemcitabine for Cancer

Phase 1

Recruiting

Research Sponsored by ADC Therapeutics S.A.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

-- Sarcoma indications (including those listed for combination therapy arms) regardless of AXL gene amplification status.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 2 years

Awards & highlights

Study Summary

This trial is studying a new cancer drug to see what the best dose is and how well it works.

Who is the study for?

This trial is for adults with advanced or metastatic solid tumors, including various sarcomas and cancers like ovarian, pancreatic, bladder, cervical, and endometrial. Participants must have measurable disease and be in good physical condition (ECOG 0-1). They should not respond to standard treatments anymore. People can't join if they've had recent serious infections, chronic diarrhea conditions, symptomatic brain metastases or require frequent drainage for fluid accumulation.Check my eligibility

What is being tested?

The study aims to find the safest dose of a new drug called Mipasetamab Uzoptirine (ADCT-601), both alone and combined with Gemcitabine chemotherapy. Researchers want to see how well patients tolerate these drugs and what effects they have on different types of solid tumors.See study design

What are the potential side effects?

Possible side effects include reactions at the infusion site where the drug enters the body through a vein; general feelings of discomfort or illness; potential impact on blood cells leading to higher infection risk; nausea; fatigue; and other symptoms that will be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My sarcoma diagnosis does not depend on AXL gene status.

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I have previously been treated with a medication that includes gemcitabine.

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My lung cancer's AXL gene status does not matter.

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I have never been treated with gemcitabine.

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My cancer type is one of the specified types and has AXL gene amplification.

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My cancer is a type of soft tissue sarcoma.

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My cancer is advanced or has spread to other parts of my body.

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My cancer is a type of bone sarcoma, such as Ewing's, osteosarcoma, or chondrosarcoma.

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My solid tumor has AXL gene amplification.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants who Experience a Dose Interruption

Number of Participants who Experience a Dose Limiting Toxicity (DLT)

Number of Participants who Experience a Dose Reduction

+1 more

Secondary outcome measures

Accumulation Index (AI) of ADCT-601 Total Antibody, Pyrrolobenzodiazepine (PBD)-Conjugated Antibody, and Unconjugated Warhead SG3199 in Serum

Antibodies

+13 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Part 2: Dose Expansion, ADCT-601 MonotherapyExperimental Treatment1 Intervention

In Part 2 (dose expansion), participants with a selected indication will receive ADCT-601 monotherapy. Participants will be split into cohorts: Cohort 1: Soft tissue sarcoma (STS). Cohort 2: Pancreatic adenocarcinoma (PAAD). Cohort 3: NSCLC. Cohort 4: Solid tumors with known AXL expression.

Group II: Part 2: Dose Expansion, ADCT-601 Combination TherapyExperimental Treatment2 Interventions

In Part 2 (dose expansion), participants with selected sarcoma indications will receive ADCT-601 in combination with gemcitabine. Participants will be split into 3 cohorts: Cohorts 5 and 6: Sarcoma indications. Cohort 7: Pancreatic cancer.

Group III: Part 1: Dose Escalation, ADCT-601 MonotherapyExperimental Treatment1 Intervention

In Part 1 (dose escalation), participants with sarcoma indications (regardless of AXL gene amplification status), non-small-cell lung cancer (NSCLC) (regardless of AXL gene amplification status), and solid tumors with AXL gene amplification, will receive ADCT-601 monotherapy.

Group IV: Part 1: Dose Escalation, ADCT-601 Combination TherapyExperimental Treatment2 Interventions

In Part 1 (dose escalation), participants with selected sarcoma indications will receive escalating doses of ADCT-601 in combination with gemcitabine.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gemcitabine

2017

Completed Phase 3

~2070

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

ADC Therapeutics S.A.Lead Sponsor

28 Previous Clinical Trials

2,037 Total Patients Enrolled

Media Library

Gemcitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT05389462 — Phase 1

Solid Tumors Clinical Trial 2023: Gemcitabine Highlights & Side Effects. Trial Name: NCT05389462 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there open slots available for participants in this experiment?

"Affirmative. The clinicaltrials.gov database displays that this investigation is actively seeking participants, which was initially published on July 13th 2022 and updated most recently on November 18th 2022. This trial necessitates 66 volunteers to be recruited from 5 different facilities."

Answered by AI

Has the FDA granted authorization for ADCT-601?

"Since ADCT-601 is in the early stages of clinical testing, with limited data on both safety and efficacy, our team estimated it to have a score of 1."

Answered by AI

How many participants are being recruited for this trial?

"Correct. The clinicaltrial.gov website confirms that this medical inquiry is actively seeking participants, with 66 subjects required from five separate trial sites since its inception on July 13th 2022 and last modification November 18th 2022."

Answered by AI

How many medical facilities are currently conducting this experiment?

"Patients are welcome to join this trial at Washington University School of Medicine in Saint Louis, Missouri; Vanderbilt University Medical Center (VUMC) - Ingram Cancer Center in Nashville, Tennessee; and Sarah Cannon at the University of Oklahoma Health Sciences Centre in Oklahoma City. Additionally, there are two other locations participating in recruitment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Mipasetamab Uzoptirine (ADCT-601) in Participants With Solid Tumors

2022. "A Study of Mipasetamab Uzoptirine (ADCT-601) in Participants With Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05389462.