Phase
Condition
Neoplasms
Adenocarcinoma
Non-small Cell Lung Cancer
Treatment
Paclitaxel
Cisplatin
Nab paclitaxel
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Have one of the following locally advanced or metastatic solid tumor malignancy withSMARCA4 (BRG1) alteration:
Phase 1a dose escalation: Presence of any alteration in SMARCA4 (BRG1)
Phase 1b expansion: Part A: Non-small Cell Lung Cancer (NSCLC) that is locallyadvanced and not suitable for definitive locoregional therapy, or metastaticwith presence of a known or likely loss of function alteration in SMARCA4 (BRG1) or loss of protein expression.
Phase 1b expansion: Part B: Any tumor type (other than NSCLC) that has thepresence of a known or likely loss of function alteration in SMARCA4 (BRG1) orloss of protein expression.
Phase 1b expansion: Part C: Non-small Cell Lung Cancer (NSCLC) that is locallyadvanced and not suitable for definitive locoregional therapy, or metastaticwith presence of a known or likely loss of function alteration in SMARCA4 (BRG1) or loss of protein expression.
Prior Systemic Therapy Criteria:
Phase 1a dose escalation and Phase 1b (Part B): Participants who received allstandard therapies for which the individual was deemed to be an appropriatecandidate by the treating Investigator; or the individual is refusing theremaining most appropriate standard of care treatment; or there is no standardtherapy available for the disease.
Phase 1b expansion (Part A): Participants must have received at least one lineof therapy for advanced or metastatic disease.
Phase 1b expansion (Part C): Participants may be treatment naïve or havereceived therapy for advanced or metastatic disease
Measurability of disease
Phase 1a dose escalation (excluding backfill): measurable or non-measurabledisease as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECISTv1.1)
Phase 1a backfill and Phase 1b expansion: Measurable disease required asdefined by RECIST v1.1
Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Exclusion
Exclusion Criteria:
Participants with known or likely loss of function alteration of SMARCA2 (BRM) ormalignancy with known association with SMARCA2 (BRM) alterations
Prior exposure to SMARCA2 (BRM) inhibitor(s) and/or degrader(s) (prior exposure maybe permitted for dose escalation)
Participants with known or suspected history of untreated or uncontrolled centralnervous system (CNS) involvement
Participants with history of increased risk of prolonged QT or significant arrythmia
Significant cardiovascular disease
Participants with active and/or treated for an additional primary malignancy within 2 years prior to enrolment
Participants who are pregnant, breastfeeding or plan to breastfeed or expecting toconceive or father children during study or within 6 months after the last dose ofstudy intervention
Participants with history of active autoimmune diseases, history of allogenic stemcell/organ transplant or compromised immune system within past 2 years (Part C only)
Study Design
Connect with a study center
Institut Bergonie
Bordeaux, 33 076
FranceSite Not Available
Institut Curie
Paris, 75248
FranceActive - Recruiting
Institut Gustave Roussy-Gustave Roussy Cancer Center -DITEP
Villejuif, 94800
FranceSite Not Available
Charite-Universitatsmedizin Berlin
Berlin, 10117
GermanySite Not Available
Universitaetsklinikum Essen
Essen, 45147
GermanySite Not Available
Krankenhaus Nordwest
Frankfurt am Main, 60488
GermanySite Not Available
National Cancer Center Hospital
Chuo-ku, Tokyo 104-0045
JapanActive - Recruiting
The Cancer Institute Hospital of JFCR
Koto City, Tokyo 135-8550
JapanActive - Recruiting
National Cancer Center Hospital
Chūōku, 104-0045
JapanActive - Recruiting
National Cancer Center Hospital East
Kashiwa, 277-8577
JapanActive - Recruiting
The Cancer Institute Hospital of JFCR
Kōtō City, 135-8550
JapanActive - Recruiting
Shizuoka Cancer Center
Nagaizumi-cho,Sunto-gun, 411-8777
JapanActive - Recruiting
Aichi Cancer Center Hospital
Nagoya, 464-8681
JapanActive - Recruiting
National Cancer Center
Ilsandong-gu, 10408
South KoreaSite Not Available
Severance Hospital, Yonsei University Health System
Seoul, 03722
South KoreaActive - Recruiting
The Catholic University of Korea, St. Vincent's Hospital
Suwon, 16247
South KoreaActive - Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
SpainSite Not Available
South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz
Madrid, 28040
SpainActive - Recruiting
UCLA
Santa Monica, California 90404
United StatesActive - Recruiting
University of Colorado Health Hospital
Aurora, Colorado 80045
United StatesActive - Recruiting
Sarah Cannon Research Institute at HealthOne
Denver, Colorado 80218
United StatesActive - Recruiting
Florida Cancer Specialists ORLANDO/DDU
Lake Mary, Florida 32746
United StatesSite Not Available
University of Miami
Miami, Florida 33136
United StatesActive - Recruiting
University of Chicago
New Lenox, Illinois 60451
United StatesActive - Recruiting
The University of Illinois at Chicago
Chicago 4887398, Illinois 4896861 60637
United StatesActive - Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United StatesActive - Recruiting
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
Dana-Farber Cancer Institute
Boston 4930956, Massachusetts 6254926 02215
United StatesActive - Recruiting
Columbia University Medical Center
New York, New York 10032
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesActive - Recruiting
Columbia University Medical Center
New York 5128581, New York 5128638 10032
United StatesActive - Recruiting
Ohio State University Hospital
Columbus, Ohio 43210
United StatesActive - Recruiting
SCRI Oncology Partners
Nashville, Tennessee 37203
United StatesActive - Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee 37203
United StatesActive - Recruiting
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee 37232-6307
United StatesActive - Recruiting
SCRI Oncology Partners
Nashville 4644585, Tennessee 4662168 37203
United StatesActive - Recruiting
Sarah Cannon Research Institute
Nashville 4644585, Tennessee 4662168 37203
United StatesActive - Recruiting
MD Anderson Cancer Center
Houston, Texas 77030-4009
United StatesActive - Recruiting
USO-Virginia Cancer Specialists, PC
Fairfax, Virginia 22031
United StatesActive - Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesActive - Recruiting

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