Breast CancerPhase 1NCT03125200
Study of ADCT-502 in Patients With Advanced Solid Tumors Withhuman Epidermal Growth Factor Receptor-2 (HER2) Expression
A Phase 1 study testing ADCT-502 in people with Breast Cancer and Non Small Cell Lung Cancer, run by ADC Therapeutics S.A. at 5 sites in 2 countries.
Trial summary
This study evaluated ADCT-502 in participants with Advanced Solid Tumors with HER2 Expression. Participants participated in a dose-escalation phase (Part 1) and were due to participate in the dose expansion phase (Part 2). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Non Small Cell Lung Cancer, GastroEsophageal Cancer
- What is being tested?
- ADCT-502
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 18 May 2017to 5 Apr 2018
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Male or female age 18 years or older
- Refractory to or intolerant of existing therapy(ies) known to provide clinical benefit for their condition.
- Eastern Cooperative Oncology Group (ECOG) performance status: Part 1: 0-2, Part 2: 0-1
- Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block or unstained slides to demonstrate HER2 expression.
- Pathologic diagnosis of solid tumor malignancy that is locally advanced or metastatic at time of Screening with documented HER2 expression.
- Part 2/Dose Expansion Only: Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Absolute neutrophil count (ANC) ≥ 1500/mm3 (≥1.5× 109/L).
- Platelet count ≥100,000 //mm3 (≥100 × 109/L).
- Hemoglobin ≥ 9 g/L (≥5.6 mmol/L).
- Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN); or ≤ 5.0 × ULN if liver metastases are present.
- Total bilirubin ≤ 1.5× ULN (or ≤ 3× ULN, with direct bilirubin ≤1.5 × ULN, in participants with known Gilbert syndrome).
- Creatinine ≤ 1.5× ULN; or, if serum creatinine > 1.5 × ULN, a measured creatinine clearance must be >60mL/min/1.73m2 as calculated by the Cockcroft and Gault equation for participants to be eligible.
- Women of childbearing potential must agree to use a highly effective method of contraception from the time of giving informed consent until at least 16 weeks after the last dose of ADCT-502. Men with female partners who are of childbearing potential must agree that they or their partners will use a highly effective method of contraception from the time of giving informed consent until at least 16 weeks after the participant receives his last dose of ADCT-502.
Main Exclusion Criteria:
- Known history of ≥ Grade 3 hypersensitivity to a therapeutic antibody.
- Known history of positive serum human anti-drug antibody (ADA) to trastuzumab.
- Major surgical procedure or significant traumatic injury, radiotherapy, chemotherapy, targeted therapy, hormone therapy, or other anticancer therapy.
- Failure to recover to Grade 0 or Grade 1 from acute non-hematologic toxicity due to previous therapy, prior to screening (with the exception of alopecia).
- Central Nervous System (CNS) disease only.
- Symptomatic CNS metastases or evidence of leptomeningeal disease.
- Active cardiovascular disease or significant history thereof.
- Other active disease including but not limited to ulceration of the upper gastrointestinal tract, autoimmune disease, HIV infection, active Hepatitis B virus (HBV) and hepatitis C virus (HCV) infection.
- Breastfeeding or pregnant.
- Other concurrent severe and/or uncontrolled medical conditions.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Roswell Park Cancer Institute
Buffalo, New York, 14263
Memorial Sloan Kettering Memorial Hospital
New York, New York, 10065
Stanford Cancer Center
Palo Alto, California, 94304
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, 78229
About this study
Official title: A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ADCT-502 in Patients With Advanced Solid Tumors With HER2 Expression
This study evaluated ADCT-502 in participants with Advanced Solid Tumors with HER2 Expression. Participants participated in a dose-escalation phase (Part 1) and were due to participate in the dose expansion phase (Part 2). In Part 2, patients were due to receive the dose level identified in Part 1, but the study was terminated prior to the beginning of Part 2.
Read the detailed description
Study ADCT-502-101 was the first clinical study with ADCT-502 in participants with Advanced Solid Tumors with HER2 Expression.
ADCT-502 is an antibody drug conjugate (ADC) composed of an engineered version of the humanized monoclonal antibody trastuzumab, directed against the human HER2 receptor, conjugated to a pyrrolobenzodiazepine (PBD) dimer cytotoxin. ADCT-502 specifically binds to HER2, and once internalized, releases the PBD dimer to allow cross-linking of DNA and eventually trigger cell death.
The study had 2 parts. In Part 1 (dose escalation) participants received an infusion of ADCT-502, at escalating doses. Part 1 continued until the maximum tolerated dose or the recommended dose(s) and schedule(s) for expansion were determined. In Part 2 (expansion), participants were due to be assigned to the recommended dose level of ADCT-502 identified in Part 1 by the Dose Escalation Steering Committee, but the study was terminated prior to the beginning of Part 2.
For each participant, the study included a screening period (up to 28 days), a treatment period, and a follow-up period to assess disease progression and survival for up to 12 weeks after the last dose of study drug. The total study duration was dependent on overall participant tolerability to the study drug and response to treatment as participants were able to continue treatment until disease progression or unacceptable toxicity.
- Being tested
- ADCT-502
- Medical subject headings
- Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADCT-502Drug
Intravenous Infusion
| Study group | Role | What they receive |
|---|---|---|
| ADCT-502 | Experimental | Part 1 (dose escalation): Participants received an infusion of ADCT-502, at escalating doses. Part 1 continued until the maximum tolerated dose or the recommended dose(s) and schedule(s) for expansion were determined.
Part 2 (expansion): Participants were due to be assigned to the recommended dose level of ADCT-502 as identified in Part 1 by the Dose Escalation Steering Committee. Receives: Drug: ADCT-502 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experienced Dose-Limiting Toxicities
Measured: Day 1 to 3 Weeks (one cycle)
Number of Participants Who Experienced a Dose-Limiting Toxicity With a CTCAE Grade of 3 or Above
The Common Terminology Criteria For Adverse Events (CTCAE) Version 4 will be used.
Measured: Day 1 to 3 Weeks (one cycle)
Number of Participants Who Experience At Least One Treatment Emergent Adverse Event (TEAE)
An adverse event is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
Measured: Day 1 to end of trial, a maximum of 168 days (+ 30 days)
Number of Participants Who Experience At Least One Treatment Emergent Serious Adverse Event (SAE)
Measured: Day 1 to end of trial, a maximum of 168 days (+ 30 days)
Number of Participants With Clinically Significant Clinical Laboratory Tests
Clinical significance was determined by the investigator.
Measured: Day 1 to end of trial, a maximum of 168 days (+ 30 days)
Number of Participants With Clinically Significant Physical Examination Results
Clinical significance was determined by the investigator.
Measured: Day 1 to end of trial, a maximum of 168 days (+ 30 days)
Number of Participants Who Experience a Clinically Significant Change in Eastern Cooperative Oncology Group (ECOG) Performance Status
Performance status was assessed using the ECOG performance status grades. These range between Grade 0 (fully active) and Grade 5 (dead). Clinical significance was determined by the investigator.
Measured: Day 1 to end of trial, a maximum of 168 days (+ 30 days)
Number of Participants With Clinically Significant Vital Signs
Vital sign measurements include arterial blood pressure, heart rate, respiratory rate, and body temperature. Clinical significance was determined by the investigator.
Measured: Day 1 to end of trial, a maximum of 168 days (+ 30 days)
Number of Participants Who Experience Clinically Significant Electrocardiogram (ECG) Results
Standard 12-lead ECG's will be used. Clinical significance was determined by the investigator.
Measured: Day 1 to end of trial, a maximum of 168 days (+ 30 days)
Secondary outcomes (18)
Overall Response Rate (ORR)
ORR was defined as the number of participants with a best overall response of Complete Response (CR) or Partial Response (PR) at the time each participant discontinues ADCT-502. Analysis will be determined by the investigator per Response Evaluation In Solid Criteria (RECIST) version 1.1 criteria: partial response is when there is a decrease in sum of target disease ≥ 30%, and complete response is when all lesions have disappeared or all lesions have disappeared and all nodal disease is < 10 mm each.
Measured: Screening, day 1 of cycle 3 and cycle 5, then every 4 cycles, approximately every 12 weeks
Disease Control Rate (DCR)
DCR was defined as the number of participants with a best overall response of Complete Response (CR) or Partial Response (PR), or Stable Disease (SD). Analysis will be determined by the investigator per Response Evaluation In Solid Criteria (RECIST) version 1.1 criteria: stable disease is when the change is > -30% and ≤ 20%, partial response is when there is a decrease in sum of target disease ≥ 30%, and complete response is when all lesions have disappeared or all lesions have disappeared and all nodal disease is < 10 mm each.
Measured: Screening, day 1 of cycle 3 and cycle 5, then every 4 cycles, approximately every 12 weeks
Duration of Response (DOR)
DOR was defined among responders (CR or PR) as the time from the earliest date of first response until the first date of either disease progression or death due to any cause.
Measured: Screening, day 1 of cycle 3 and cycle 5, then every 4 cycles, approximately every 12 weeks
Progression-Free Survival (PFS)
PFS was defined among the efficacy population as the time from first dose of study drug until the first date of either disease progression or death due to any cause.
Measured: Screening, day 1 of cycle 3 and cycle 5, then every 4 cycles, approximately every 12 weeks
Overall Survival (OS)
Median OS was defined as the time from the beginning of study drug treatment until death due to any cause.
Measured: Screening, day 1 of cycle 3 and cycle 5, then every 4 cycles, approximately every 12 weeks
Area Under the Plasma Concentration Versus Time Curve (AUC) of ADCT-502 (Total Antibody)
Measured: Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose
Area Under the Plasma Concentration Time Curve (AUC) of Drug To-antibody Ratio [DAR] ≥0
Measured: Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose
Area Under the Plasma Concentration Versus Time Curve (AUC) of PBD-conjugated Antibody (DAR ≥1)
Measured: Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose
Area Under the Plasma Concentration Versus Time Curve (AUC) of Free Warhead SG3199
Measured: Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose
Maximum Observed Plasma Concentration (Cmax) for ADCT-502 (Total Antibody)
Measured: Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose
Maximum Observed Plasma Concentration (Cmax) for Drug To-antibody Ratio [DAR] ≥0
Measured: Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose
Maximum Observed Plasma Concentration (Cmax) for PBD-conjugated Antibody (DAR ≥1)
Measured: Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose
Maximum Observed Plasma Concentration (Cmax) for Free Warhead SG3199
Measured: Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose
Time to Reach the Maximum Plasma Concentration (Tmax) for ADCT-502 (Total Antibody)
Measured: Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose
Time to Reach the Maximum Plasma Concentration (Tmax) for Drug To-antibody Ratio [DAR] ≥0)
Measured: Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose
Time to Reach the Maximum Plasma Concentration (Tmax) for PBD-conjugated Antibody (DAR ≥1)
Measured: Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose
Time to Reach the Maximum Plasma Concentration (Tmax) for Free Warhead SG3199
Measured: Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose
Anti-drug Antibody (ADA) Titers to ADCT-502
Measured: Blood sample collection before start of infusion in Cycles 1 and 2, and on Day 1 starting with Cycle 3 until disease progression, 30 days and 12 weeks after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start18 May 2017
- Primary completion5 Apr 2018
- Study completion5 Apr 2018
Why it stopped: Safety
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- ADC Therapeutics S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03125200
- Sponsor's protocol ID
- ADCT-502-101
- Status last verified
- Jan 2021
- First submitted
- 10 Apr 2017
- Last updated
- 1 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ADCT-502 in Patients With Advanced Solid Tumors With HER2 Expression
- ClinicalTrials.gov ID
- NCT03125200
- Acronym / sponsor ID
- ADCT-502-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Safety
- Enrolment
- 21 participants (actual)
- Lead sponsor
- ADC Therapeutics S.A.Industry (pharma, biotech, devices)
- Study start
- 18 May 2017 (actual)
- Primary completion
- 5 Apr 2018 (actual)
- Study completion
- 5 Apr 2018 (actual)
- First posted
- 24 Apr 2017 (actual)
- Results
- Posted 28 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluated ADCT-502 in participants with Advanced Solid Tumors with HER2 Expression. Participants participated in a dose-escalation phase (Part 1) and were due to participate in the dose expansion phase (Part 2). In Part 2, patients were due to receive the dose level identified in Part 1, but the study was terminated prior to the beginning of Part 2.
Detailed description
Study ADCT-502-101 was the first clinical study with ADCT-502 in participants with Advanced Solid Tumors with HER2 Expression.
ADCT-502 is an antibody drug conjugate (ADC) composed of an engineered version of the humanized monoclonal antibody trastuzumab, directed against the human HER2 receptor, conjugated to a pyrrolobenzodiazepine (PBD) dimer cytotoxin. ADCT-502 specifically binds to HER2, and once internalized, releases the PBD dimer to allow cross-linking of DNA and eventually trigger cell death.
The study had 2 parts. In Part 1 (dose escalation) participants received an infusion of ADCT-502, at escalating doses. Part 1 continued until the maximum tolerated dose or the recommended dose(s) and schedule(s) for expansion were determined. In Part 2 (expansion), participants were due to be assigned to the recommended dose level of ADCT-502 identified in Part 1 by the Dose Escalation Steering Committee, but the study was terminated prior to the beginning of Part 2.
For each participant, the study included a screening period (up to 28 days), a treatment period, and a follow-up period to assess disease progression and survival for up to 12 weeks after the last dose of study drug. The total study duration was dependent on overall participant tolerability to the study drug and response to treatment as participants were able to continue treatment until disease progression or unacceptable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADCT-502 | Experimental | Drug: ADCT-502Part 1 (dose escalation): Participants received an infusion of ADCT-502, at escalating doses. Part 1 continued until the maximum tolerated dose or the recommended dose(s) and schedule(s) for expansion were determined. Part 2 (expansion): Participants were due to be assigned to the recommended dose level of ADCT-502 as identified in Part 1 by the Dose Escalation Steering Committee. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADCT-502Intravenous Infusion | Drug | ADCT-502 |
Primary outcome
Number of Participants Who Experienced Dose-Limiting Toxicities
Time frame: Day 1 to 3 Weeks (one cycle)
Number of Participants Who Experienced a Dose-Limiting Toxicity With a CTCAE Grade of 3 or Above
Time frame: Day 1 to 3 Weeks (one cycle)
The Common Terminology Criteria For Adverse Events (CTCAE) Version 4 will be used.
Number of Participants Who Experience At Least One Treatment Emergent Adverse Event (TEAE)
Time frame: Day 1 to end of trial, a maximum of 168 days (+ 30 days)
An adverse event is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
Number of Participants Who Experience At Least One Treatment Emergent Serious Adverse Event (SAE)
Time frame: Day 1 to end of trial, a maximum of 168 days (+ 30 days)
Number of Participants With Clinically Significant Clinical Laboratory Tests
Time frame: Day 1 to end of trial, a maximum of 168 days (+ 30 days)
Clinical significance was determined by the investigator.
Number of Participants With Clinically Significant Physical Examination Results
Time frame: Day 1 to end of trial, a maximum of 168 days (+ 30 days)
Clinical significance was determined by the investigator.
Number of Participants Who Experience a Clinically Significant Change in Eastern Cooperative Oncology Group (ECOG) Performance Status
Time frame: Day 1 to end of trial, a maximum of 168 days (+ 30 days)
Performance status was assessed using the ECOG performance status grades. These range between Grade 0 (fully active) and Grade 5 (dead). Clinical significance was determined by the investigator.
Number of Participants With Clinically Significant Vital Signs
Time frame: Day 1 to end of trial, a maximum of 168 days (+ 30 days)
Vital sign measurements include arterial blood pressure, heart rate, respiratory rate, and body temperature. Clinical significance was determined by the investigator.
Number of Participants Who Experience Clinically Significant Electrocardiogram (ECG) Results
Time frame: Day 1 to end of trial, a maximum of 168 days (+ 30 days)
Standard 12-lead ECG's will be used. Clinical significance was determined by the investigator.
18 secondary outcomes
Overall Response Rate (ORR)
Time frame: Screening, day 1 of cycle 3 and cycle 5, then every 4 cycles, approximately every 12 weeks
Disease Control Rate (DCR)
Time frame: Screening, day 1 of cycle 3 and cycle 5, then every 4 cycles, approximately every 12 weeks
Duration of Response (DOR)
Time frame: Screening, day 1 of cycle 3 and cycle 5, then every 4 cycles, approximately every 12 weeks
Progression-Free Survival (PFS)
Time frame: Screening, day 1 of cycle 3 and cycle 5, then every 4 cycles, approximately every 12 weeks
Overall Survival (OS)
Time frame: Screening, day 1 of cycle 3 and cycle 5, then every 4 cycles, approximately every 12 weeks
Area Under the Plasma Concentration Versus Time Curve (AUC) of ADCT-502 (Total Antibody)
Time frame: Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose
Area Under the Plasma Concentration Time Curve (AUC) of Drug To-antibody Ratio [DAR] ≥0
Time frame: Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose
Area Under the Plasma Concentration Versus Time Curve (AUC) of PBD-conjugated Antibody (DAR ≥1)
Time frame: Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose
Area Under the Plasma Concentration Versus Time Curve (AUC) of Free Warhead SG3199
Time frame: Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose
Maximum Observed Plasma Concentration (Cmax) for ADCT-502 (Total Antibody)
Time frame: Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose
Maximum Observed Plasma Concentration (Cmax) for Drug To-antibody Ratio [DAR] ≥0
Time frame: Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose
Maximum Observed Plasma Concentration (Cmax) for PBD-conjugated Antibody (DAR ≥1)
Time frame: Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose
Maximum Observed Plasma Concentration (Cmax) for Free Warhead SG3199
Time frame: Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose
Time to Reach the Maximum Plasma Concentration (Tmax) for ADCT-502 (Total Antibody)
Time frame: Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose
Time to Reach the Maximum Plasma Concentration (Tmax) for Drug To-antibody Ratio [DAR] ≥0)
Time frame: Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose
Time to Reach the Maximum Plasma Concentration (Tmax) for PBD-conjugated Antibody (DAR ≥1)
Time frame: Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose
Time to Reach the Maximum Plasma Concentration (Tmax) for Free Warhead SG3199
Time frame: Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose
Anti-drug Antibody (ADA) Titers to ADCT-502
Time frame: Blood sample collection before start of infusion in Cycles 1 and 2, and on Day 1 starting with Cycle 3 until disease progression, 30 days and 12 weeks after last dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ADCT-502 in people with Breast Cancer and Non Small Cell Lung Cancer, run by ADC Therapeutics S.A. at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experienced Dose-Limiting Toxicities (time frame: Day 1 to 3 Weeks (one cycle)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2021.