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Study of ADCT-301 in Patients With Selected Advanced Solid Tumors | Clinical Trials | Clareo Health

TERMINATEDPHASE1

Study of ADCT-301 in Patients With Selected Advanced Solid Tumors

A Phase 1b, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Camidanlumab Tesirine (ADCT-301) as Monotherapy or in Combination in Patients With Selected Advanced Solid Tumors

NCT03621982•ADC Therapeutics S.A.

View on ClinicalTrials.gov

Summary

This study evaluates ADCT-301 in patients with Selected Advanced Solid Tumors. Patients will participate in a Treatment Period with 3-week cycles and a Follow-up Period every 12 weeks for up to 1 year after treatment discontinuation.

Detailed Description

This is a Phase 1b, multi-center, open-label study with a dose-escalation part and a dose expansion part. The duration of the study participation for each participant was defined as the time from the date of signed written informed consent to the completion of the followup period, withdrawal of consent, loss to follow-up, or death, whichever occurs first. The study was include a Screening Period (of up to 21 days), a Treatment Period (with cycles of 3 weeks for a Q3W dosing regimen), and a Follow-up Period (approximately every 12 week visits) for up to 1 year after treatment discontinuation.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Written informed consent must be obtained prior to any procedures.
•2. Male or female participants aged 18 years or older.
•3. Pathologic diagnosis of solid tumor malignancy that is locally advanced or metastatic at time of Screening:
•Part 1 Dose escalation camidanlumab tesirine as monotherapy:
•Selected advanced solid tumors: colorectal, head and neck, NSCLC, gastric and esophageal cancers, pancreas, bladder, renal cell carcinoma, melanoma, TNBC, and ovarian/fallopian tube cancers
•Part 1 Dose-escalation camidanlumab tesirine in combination with pembrolizumab:
•Selected advanced solid tumors: colorectal cancer, gastric-esophageal cancer, ovarian /fallopian tube cancer, pancreatic cancer, non-small cell lung cancer, and melanoma.
•Note: For colorectal cancer, gastric-esophageal cancer, ovarian/fallopian tube cancer, pancreatic cancers mismatch repair (MMR) / microsatellite stability (MSS) / microsatellite instability (MSI) status was mandatory. If MMR/MSS/MSI status was not available at signature of the informed consent, the test should be performed before Cycle 1 Day 1 (C1D1).
•Part 2 Dose expansion camidanlumab tesirine in combination with pembrolizumab:
•* Group 1: One of the indications identified in Part 1, for which at least 1 response (PR or CR) was seen.
+18 more criteria

Exclusion Criteria

•1. Participation in another investigational interventional study.
•2. Prior therapy with a CD25 (IL-2R) antibody.
•3. Known history of ≥Grade 3 hypersensitivity to a therapeutic antibody.
•4. Participants with prior solid organ or allogeneic bone marrow transplant.
•5. History of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis \[scleroderma\], systemic lupus erythematosus, Sjögren's syndrome, autoimmune vasculitis \[e.g., Wegener's granulomatosis\]) (participants with vitiligo, type 1 diabetes mellitus, residual hypothyroidism, hypophysitis due to autoimmune condition only requiring hormone replacement may be enrolled).
•6. History of neuropathy considered of autoimmune origin (e.g., polyradiculopathy including Guillain-Barré syndrome and myasthenia gravis) or other central nervous system (CNS) autoimmune disease (e.g., poliomyelitis, multiple sclerosis).
•7. History of recent infection (within 4 weeks of C1D1) caused by a pathogen known to be associated with GBS, for example: herpes simplex virus 1/2 (HSV1, HSV2), varicella zoster virus (VZV), Epstein-Barr virus (EBV), cytomegalovirus (CMV), measles, Influenza A, Zika virus, Chikungunya virus, mycoplasma pneumonia, Campylobacter jejuni, enterovirus D68, or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
•Note: An influenza test and a pathogen-directed SARS-CoV-2 test (such as polymerase chain reaction \[PCR\]) were mandatory and must be negative before initiating study treatment (tests to be performed 3 days or less prior to dosing on C1D1; an additional 2 days were allowed in the event of logistical issues for receiving the results on time).
•8. Known seropositive and requiring anti-viral therapy for human immunodeficiency (HIV) virus, hepatitis B virus (HBV), or hepatitis C virus (HCV). Note: Testing was not mandatory to be eligible but should be considered in participants with high risk for these infections; testing was mandatory if status was unknown.
•9. History of Stevens-Johnson syndrome or toxic epidermal necrolysis.
+19 more criteria

Locations (9)

Stanford Cancer Center

Palo Alto, California, United States

Smilow Cancer Hospital Phase 1 Unit

New Haven, Connecticut, United States

Oregon Health and Science University

Portland, Oregon, United States

The Sarah Cannon Research Institute

Nashville, Tennessee, United States

The START Center for Cancer Care

San Antonio, Texas, United States

Institut Jules Bordet

Anderlecht, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

University College London Hospitals NHS Foundation Trust

London, England, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

Key Dates

Start Date

November 9, 2018

Primary Completion Date

December 14, 2022

Completion Date

December 14, 2022

Last Updated

June 13, 2024

Enrollment

ACTUAL participants

Conditions

Head and Neck Cancer Squamous Cell CarcinomaNon-small Cell Lung CancerGastric CancerEsophageal CancerPancreas CancerBladder CancerRenal Cell CarcinomaMelanomaTriple-negative Breast CancerOvarian CancerColo-rectal CancerFallopian Tube Cancer

Interventions

ADCT-301

DRUG

Pembrolizumab

BIOLOGICAL

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

NCT06305754

Non-small Cell Lung Cancer (NSCLC)

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RECRUITINGPHASE1

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

NCT04704661

Advanced Breast CarcinomaAdvanced Colon Carcinoma+38 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 13, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study of ADCT-301 in Patients With Selected Advanced Solid Tumors

Inclusion Criteria

Exclusion Criteria

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)