Phase
Condition
Non-small Cell Lung Cancer
Rectal Cancer
Colon Cancer
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Kirsten rat sarcoma virus homolog (KRAS) glycine-to-cysteine (G12C) mutation in tumortissue or blood
- Histological documentation of disease: Part 1: Histologically or cytologicallyconfirmed solid tumor malignancy that is metastatic or unresectable, Part 2: (a)unresectable, locally advanced (Stage IIIB) or metastatic (Stage IV) non-small celllung cancer (NSCLC), (b) Solid tumor malignancy other than NSCLC that is metastatic orunresectable
- Received or was ineligible for standard treatment options. For NSCLC: previouslyreceived a platinum-containing chemotherapy regimen and an anti- programmeddeath-ligand 1 (PD1/PDL1) antibody, unless participant refused or was ineligible toreceive such therapy; and for colorectal cancer (CRC): previously received at least 2prior lines of therapy, including a fluoropyrimidine, oxaliplatin, and irinotecan,unless participant refused or was ineligible to receive such therapy. For Participantsin France only: NSCLC: Previously received a platinum-containing chemotherapy regimenand an anti-PD1/PDL1 antibody or was ineligible to receive such therapy. CRC:Previously received at least 2 prior lines of therapy, including a fluoropyrimidine,oxaliplatin, and irinotecan or was ineligible to receive such therapy
- Measurable or evaluable disease: Part 1: either measurable or evaluable disease, Part 2: At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
Exclusion
Exclusion Criteria:
- Symptomatic brain metastases or known leptomeningeal disease; asymptomatic brainmetastases are allowed if they have been treated, have been stable for greater than orequal to (>=) 4 weeks as documented by radiographic imaging, and do not requireprolonged (greater than [>]14 days) systemic corticosteroid therapy. Participants whohave had complete surgical resection of or received stereotactic radiosurgery to lessthan or equal to (<=) 3 metastatic lesions will be permitted to enroll in the studywithin 14 days of such treatment if they have recovered from treatment, are clinicallystable, and do not require prolonged systemic corticosteroid therapy as noted above
- Prior treatment with an inhibitor specific to KRAS G12C
- Prior solid organ transplantation
- History of malignancy (other than the disease under study) within 2 years before thefirst administration of study drug. Exceptions include squamous and basal cellcarcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in theopinion of the investigator, with concurrence with the sponsor's medical monitor, isconsidered cured with minimal risk of recurrence within 2 years
- Inability to take an orally administered drug, or medical disorder or prior surgicalresection that may affect the absorption of the study drug. Such conditions include,but are not limited to, malabsorption syndrome, symptomatic inflammatory boweldisease, partial or complete bowel obstruction, or resection of the stomach or smallbowel. If any of these conditions exist, the investigator should discuss with thesponsor to determine participant eligibility
Study Design
Study Description
Connect with a study center
Centre Leon Bérard
Lyon Cedex 8, 69373
FranceSite Not Available
Hopital de la Timone
Marseille, 13885
FranceSite Not Available
Institut Gustave Roussy
Villejuif, 94800
FranceSite Not Available
Hosp. Univ. Vall D'Hebron
Barcelona, 8035
SpainSite Not Available
Hosp. Univ. Fund. Jimenez Diaz
Madrid, 28040
SpainSite Not Available
Hosp. Virgen de La Victoria
Málaga, 29010
SpainSite Not Available
Cedars Sinai Medical Center
Los Angeles, California 90048
United StatesSite Not Available
Florida Cancer Specialists
Sarasota, Florida 34232
United StatesSite Not Available
H. Lee Moffitt Cancer & Research Institute
Tampa, Florida 33612
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesSite Not Available
Sarah Cannon Research Institute
Nashville, Tennessee 37203
United StatesSite Not Available
NEXT Oncology
San Antonio, Texas 78229
United StatesSite Not Available

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