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Antibody Drug Conjugate

Pembrolizumab for Stomach Cancer

Phase 1
Waitlist Available
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
Written informed consent must be obtained prior to any procedures.
Male or female patient aged 18 years or older.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is testing a new cancer drug in patients with advanced solid tumors. Patients will take the drug every 3 weeks for a year, then be monitored every 12 weeks.

Eligible Conditions
  • Stomach Cancer
  • Colorectal Cancer
  • Esophageal Cancer
  • Breast Cancer
  • Melanoma
  • Non-Small Cell Lung Cancer
  • Bladder Cancer
  • Ovarian Cancer
  • Solid Tumors
  • Pancreatic Cancer
  • Kidney Cancer
  • Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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
Part 1 Combination Therapy: Number of Patients Who Experience a Serious Adverse Event (SAE)
Part 1 Combination Therapy: Number of Patients Who Experience a Treatment-emergent Adverse Event (TEAE)
Part 1 Combination Therapy: Number of Patients Who Experience a Treatment-emergent Adverse Event (TEAE) of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or Above
+29 more
Secondary outcome measures
Part 1 Combination Therapy: Accumulation Index (AI) of Camidanlumab Tesirine in Serum
Part 1 Combination Therapy: Area Under the Concentration-time Curve from Time Zero to Infinity (AUC0-∞) of Camidanlumab Tesirine in Serum
Part 1 Combination Therapy: Area Under the Concentration-time Curve from Time Zero to the End of the Dosing Interval (AUC0-τ) Camidanlumab Tesirine in Serum
+36 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Part 2: Dose expansion, ADCT-301 Combination TherapyExperimental Treatment2 Interventions
In Part 2 (dose expansion), patients will receive ADCT-301 in combination with pembrolizamab as combination therapy at the dose identified in Part 1 (dose escalation). Patients will be split into two groups: Group 1: One of the indications identified in Part 1, for which at least 1 response (PR [partial response] or CR [complete response]) was seen. Group 2: A basket group of patients with advanced/metastatic solid tumors and microsatellite instability/deficient MisMatch Repair (MSI-H/dMMR) status, who have received prior regimen containing a PD-1/PD-L1 inhibitor, for which the best response was CR, PR, or SD (stable disease) ≥4 months, and then progressed while continuing on the PD-1/PD-L1 inhibitor-based regimen.
Group II: Part 1: Dose Escalation, ADCT-301 MonotherapyExperimental Treatment1 Intervention
In Part 1 (dose escalation) patients will receive escalating doses of ADCT-301 as monotherapy.
Group III: Part 1: Dose Escalation, ADCT-301 Combination TherapyExperimental Treatment2 Interventions
In Part 1 (dose escalation) patients will receive escalating doses of ADCT-301 in combination with pembrolizamab as combination therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

ADC Therapeutics S.A.Lead Sponsor
28 Previous Clinical Trials
2,155 Total Patients Enrolled

Frequently Asked Questions

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

What is the total cohort size of this medical trial?

"For the trial to be conducted, ADC Therapeutics S.A. requires 95 participants fitting the specifications of their inclusion criteria. These patients will mainly come from Yale School of Medicine in New Haven and SCRI - Tennessee Oncology - Nashville - Southern Hills Clinic in Nashville, although there may be other locations used as well."

Answered by AI

How many geographical areas is this trial administered in?

"Yale School of Medicine in New Haven, Connecticut, SCRI - Tennessee Oncology - Nashville - Southern Hills Clinic in Nashville, Tennessee and Smilow Cancer Hospital Phase 1 Unit in Portland, Oregon are all hosting this clinical trial. In addition to these sites 9 other institutions have also been chosen for recruitment purposes."

Answered by AI

Are there any related experiments to ADCT-301 that have already been conducted?

"The first trial for ADCT-301 took place in 2010 at City of Hope. Since then, 252 studies have been completed with a further 963 actively recruiting clinical trials taking place across the US, particularly from New Haven Connecticut."

Answered by AI

What medical conditions is ADCT-301 typically used to treat?

"ADCT-301 is typically prescribed to address malignant tumors. It can also be beneficial in cases of unresectable melanoma, microsatellite instability high, and after chemotherapy treatment has failed to achieve desired outcomes."

Answered by AI

Are there any vacancies left for this research endeavor?

"This study, initially posted on November 9th 2018 and revised October 27th 2022 is in need of enrollees. A cursory glance at clinicaltrials.gov confirms this fact."

Answered by AI

Has the regulatory body approved the use of ADCT-301?

"ADCT-301's safety is still being evaluated, so it received a score of 1. This is the first phase in its clinical trial process, where initial data regarding efficacy and safety are collected."

Answered by AI

What impact is this clinical trial aiming to achieve?

"According to the trial sponsor, ADC Therapeutics S.A., this study will evaluate a range of outcomes over 3 years including Part 1 Monotherapy: Changes in 12-lead Electrocardiograms (ECGs) from baseline; Part 1 Combination Therapy: Area Under the Concentration-time Curve from Time Zero to Last Quantifiable Concentration (AUC0-last); Part 2 Combination Therapy: Progression-free survival (PFS); and Part 1 Monotherapy: Area Under the Concentration-time Curve from Time Zero to Infinity (AUC0–∞)."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of ADCT-301 in Patients With Selected Advanced Solid Tumors
2018. "Study of ADCT-301 in Patients With Selected Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03621982.
~12 spots leftby Apr 2025
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