Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Digestive System Diseases

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Squamous Cell

Stomach Neoplasms

Breast Neoplasms

Triple Negative Breast Neoplasms

Esophageal Neoplasms

Pancreatic Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Urinary Bladder Neoplasms

Melanoma

Carcinoma, Renal Cell

Head and Neck Neoplasms

Fallopian Tube Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Skin Diseases

Endocrine Gland Neoplasms

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Urologic Neoplasms

Urologic Diseases

Male Urogenital Diseases

Adenocarcinoma

Kidney Neoplasms

Kidney Diseases

Breast Diseases

Fallopian Tube Diseases

Pancreatic Diseases

Stomach Cancer

Esophageal Cancer

Pancreatic Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Fallopian Tube Cancer

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

In Part 1 (dose escalation) patients will receive escalating doses of ADCT-301 as monotherapy.

In Part 1 (dose escalation) patients will receive escalating doses of ADCT-301 in combination with pembrolizamab as combination therapy.

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.

ADCT-301

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.

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 patient is defined as the time from the date of signed written informed consent to the completion of the follow-up period, withdrawal of consent, loss to follow-up, or death, whichever occurs first.

The study will 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

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

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an AE that occurs or worsens in the period extending from the first dose of study drug to 30 days after the last dose of study drug in this study or start of a new anticancer therapy, whichever is earlier.

AEs will be graded according to CTCAE v4.0 (or more recent). For events not included in the CTCAE criteria, the severity of the AE will be graded on a scale of 1 to 5, where 1 is asymptomatic or mild symptoms and 5 is death related to an AE.

A SAE is defined as any AE that results in death, is life threatening, requires inpatient hospitalization of prolongation of existing hospitalization (hospitalization for elective procedures or for protocol compliance is not considered an SAE), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or important medical events that do not meet the preceding criteria but based on appropriate medical judgement may jeopardize the patient or may require medical or surgical intervention to prevent any of the outcomes listed above.

ORR assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.

DOR is defined as the time from the first documentation of tumor response to disease progression as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.

PFS is defined as the time between start of treatment and the first documentation of recurrence or progression as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.

OS is defined as the time between the start of treatment and death from any cause.

Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured.

ADA titers if applicable, neutralizing activity to camidanlumab tesirine after treatment with camidanlumab tesirine.

ADC Therapeutics S.A.

Spots Global Cancer Trial Database for Study of ADCT-301 in Patients With Selected Advanced Solid Tumors

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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