KRAS G12D 돌연변이가 있는 진행성 또는 전이성 대장암 환자에서 BAY 3771249의 안전성과 효과에 대한 연구
마스터 프로토콜: KRAS G12D 돌연변이를 보유한 고형 종양 환자를 대상으로 BAY 3771249 단독 요법 또는 다른 암 치료와의 병용 요법의 안전성, 내약성, 약동학, 약력학 및 효능을 평가하는 개방형 연구 서브스터디 프로토콜: KRAS G12D 돌연변이를 보유한 진행성/전이성 대장 선암종 환자를 대상으로 BAY 3771249 단독 요법 및 세툭시맙과의 병용 요법의 안전성, 내약성, 약동학, 약력학 및 예비 항종양 활성을 평가하는 개방형, 다중 코호트 연구
Researchers are looking for a better way to treat people who have advanced or metastatic colorectal cancer (CRC) with a specific mutation, the G12D mutation, in a protein called KRAS.
Colorectal cancer (CRC) is a common type of cancer that affects the large bowel (colon) or the rectum (the section at the end of the bowel). When CRC spreads to other parts of the body, it is called advanced or metastatic CRC. Some people with CRC have the G12D mutation in the KRAS protein. This mutation is linked to a poorer outlook and fewer treatment options. Currently, there are no approved treatments that specifically target this mutation.
KRAS is a protein that helps control how cells grow and divide. When it is mutated, it can cause cells to grow uncontrollably, leading to cancer. The study drug, BAY 3771249, is designed to block the activity of KRAS with G12D mutation, which may help slow or stop the growth of cancer cells. BAY 3771249 can be given alone or together with another drug called cetuximab.
The main purpose of this study is to learn how safe BAY 3771249 is, how well people tolerate it, how the body processes the drug, and whether it can help shrink or control tumors in people with advanced or metastatic CRC that has the KRAS G12D mutation. The study will also look at how BAY 3771249 works when given alone or with cetuximab, especially in people who have already tried other treatments for their cancer.
Researchers will measure, among others:
The number and seriousness of health problems (adverse events) after receiving BAY 3771249.
The number of participants who experience a dose-limiting side effect (DLT) at each dose level.
The number of participants whose tumors shrink or disappear (overall response rate, ORR) as measured by standard criteria.
How much of the drug is in the blood over time (AUC) and the highest amount in the blood (Cmax).
Some participants will receive BAY 3771249 alone (monotherapy), and others will receive BAY 3771249 with cetuximab (combination therapy).
The study will start with lower doses and gradually increase to find the highest safe dose (dosage escalation). After the safe dose is found, more participants may join the study to receive it (dosage expansion). In some parts of the study, participants may be randomly assigned to different groups or doses. The study is open-label, meaning both participants and doctors know which treatment is being given.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, even if they do not think it is related to the study treatment.
The study doctors and their team will contact participants to learn about their health until they complete the study.
If a participant benefits from the treatment, it might be possible to continue receiving BAY 3771249 after the end of the study. The findings from this study may help develop a new treatment option for people with advanced or metastatic CRC with a KRAS G12D mutation.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 1단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Bayer Clinical Trials Contact
- 전화번호: 18888422937
- 이메일: clinical-trials-contact@bayer.com
연구 장소
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North Holland
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Amsterdam, North Holland, 네덜란드, 1066 CX
- 아직 모집하지 않음
- Nederlands Kanker Instituut
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Capital Region / Region Hovedstaden
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Copenhagen, Capital Region / Region Hovedstaden, 덴마크, 2100
- 아직 모집하지 않음
- Rigshospitalet Copenhagen University Hospital | Oncology Department
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Region of Southern Denmark / Region Syddanmark
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Odense, Region of Southern Denmark / Region Syddanmark, 덴마크, 5000
- 아직 모집하지 않음
- Odense University Hospital | Svendborg Sygehus - Oncology Department
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Arizona
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Phoenix, Arizona, 미국, 85054
- 아직 모집하지 않음
- Mayo Clinic - Cancer Center - Phoenix
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California
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Duarte, California, 미국, 91010
- 모병
- City of Hope - Duarte Cancer Center
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San Diego, California, 미국, 92037
- 아직 모집하지 않음
- UC San Diego Health - Moores Cancer Center
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Colorado
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Denver, Colorado, 미국, 80218
- 빼는
- Sarah Cannon Research Institute at HCA HealthONE Presbyterian St. Luke's
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New York
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New York, New York, 미국, 10029
- 아직 모집하지 않음
- Icahn School of Medicine at Mount Sinai - Oncology
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Texas
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Irving, Texas, 미국, 75039
- 모병
- NEXT Dallas - Oncology Department
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San Antonio, Texas, 미국, 78229
- 모병
- START | San Antonio
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East Flanders
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Ghent, East Flanders, 벨기에, 9000
- 아직 모집하지 않음
- Ghent University Hospital | Drug Research Unit Department
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Stockholm County
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Stockholm, Stockholm County, 스웨덴, 171 76
- 아직 모집하지 않음
- Karolinska Universitetssjukhuset - Solna - Fas I-enheten Solna CKC
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Barcelona
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Barcelona, Barcelona, 스페인, 08035
- 아직 모집하지 않음
- Hospital Universitari Vall D Hebron | Oncologia
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Madrid
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Madrid, Madrid, 스페인, 28050
- 아직 모집하지 않음
- Hospital Universitario Hm Sanchinarro | Oncologia
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Singapore, 싱가포르, 119074
- 모병
- National University Hospital Medical Centre
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Singapore, 싱가포르, 168583
- 모병
- National Cancer Center Singapore - Oncology Department
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Roma, 이탈리아, 00128
- 아직 모집하지 않음
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Fase I
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Uusimaa
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Helsinki, Uusimaa, 핀란드, 00029
- 아직 모집하지 않음
- HUS-Yhtymä, Helsingin yliopistollinen sairaala (HUS) - Syöpäkeskus
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New South Wales
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Albury, New South Wales, 호주, 2640
- 아직 모집하지 않음
- Border Medical oncology - Albury Wodonga Regional Cancer Centre
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Waratah, New South Wales, 호주, 2298
- 모병
- Calvary Mater Hospital Newcastle - Oncology
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Victoria
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Malvern, Victoria, 호주, 3144
- 아직 모집하지 않음
- Cabrini Health Oncology Research
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- KRAS G12D mutated solid tumor
- Participant must be ≥18 years old or the legal age of consent in the jurisdiction in which the study is taking place when signing the screening ICF
- At least one measurable lesion as per RECIST v1.1. outside the CNS
- Eastern Cooperative Oncology Group performance status (ECOG PS) of ≤1
- Male or Female: Contraceptive use by participant or participant's partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Life expectancy of at least 3 months in the opinion of the Investigator
- Histologically/pathologically documented diagnosis of advanced/metastatic adenocarcinoma of the colon and rectum.
- Adequate hematologic and end-organ function
Exclusion Criteria:
- Leptomeningeal disease or carcinomatous meningiti
- Uncontrolled and/or active/symptomatic brain metastases.
- Significant traumatic injury or major surgical procedure within 4 weeks of first dose of study intervention
- Known hypersensitivity to any component of study intervention
- Previous (within 3 years) or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in the respective substudy.
- Active infection requiring systemic anti-infective therapy within 14 days of first dose of study intervention
- Known HIV infection
- Active Hepatitis B virus (HBV) infection
- Active Hepatitis C virus (HCV) infection
- Significant cardiac disorder
- History of risk factors for torsade de pointes (TdP) (e.g., heart failure, family history of long QT syndrome)
- Participants with inadequately managed diabetes as assessed by the Investigator
- Toxicities from prior anticancer therapy, defined as not having resolved to Grade ≤1 or as specified in the respective substudy protocol as per NCI CTCAE v.6.0 with the following exceptions: Alopecia of any grade, Peripheral neuropathy Grade ≤2, Autoimmune endocrine disorders Grade ≤2 managed with stable endocrine replacement therapy
- History of (non-infectious) pneumonitis/interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis (unless it has resolved without sequelae without use of steroids), or any evidence of clinically-active pneumonitis/ILD
- History of the following eye disorders: keratitis, ulcerative keratitis
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: Dosage escalation
In the dosage escalation part, different dose levels of BAY 3771249 administered as monotherapy and in combination with cetuximab are planned. |
Oral Intravenous (IV) infusion |
|
실험적: Dosage expansion
In the dosage expansion part, participants will receive BAY 3771249 either as monotherapy or in combination with cetuximab until disease progression as defined by RECIST v1.1, the occurrence of unacceptable toxicity, or the fulfillment of any other withdrawal criteria. |
Oral Intravenous (IV) infusion |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from baseline in laboratory test results
기간: Up to approximately 2 years
|
Hematology, serum chemistry, urinalysis and coagulation tests. Applicable in Dosage escalation and expansion |
Up to approximately 2 years
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Change from baseline in vital signs: Blood pressure
기간: Up to approximately 2 years
|
Applicable in Dosage escalation and expansion |
Up to approximately 2 years
|
|
Change from baseline in vital signs: Body temperature
기간: Up to approximately 2 years
|
Applicable in Dosage escalation and expansion |
Up to approximately 2 years
|
|
Change from baseline in vital signs: Oxygen saturation
기간: Up to approximately 2 years
|
Applicable in Dosage escalation and expansion |
Up to approximately 2 years
|
|
Change from baseline in vital signs: Pulse rate
기간: Up to approximately 2 years
|
Applicable in Dosage escalation and expansion |
Up to approximately 2 years
|
|
Change from baseline in vital signs: Respiratory rate
기간: Up to approximately 2 years
|
Applicable in Dosage escalation and expansion |
Up to approximately 2 years
|
|
Number of participants experiencing a dose-limiting toxicity (DLT) at each dosage
기간: Up to approximately 3 weeks
|
Applicable in Dose escalation part |
Up to approximately 3 weeks
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Number of participants with Treatment-emergent adverse events (TEAEs)
기간: Up to approximately 2 years.
|
Applicable in Dosage escalation and expansion |
Up to approximately 2 years.
|
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Objective response rate (ORR) as determined by the Investigator according to RECIST v1.1
기간: Up to approximately 2 years
|
Applicable in Dosage escalation and expansion |
Up to approximately 2 years
|
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Severity of TEAEs
기간: Up to approximately 2 years.
|
Applicable in Dosage escalation and expansion |
Up to approximately 2 years.
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pharmacokinetics (PK) parameters such as area under the concentration vs time curve (AUC)
기간: Up to approximately 2 years
|
Applicable in Dosage escalation |
Up to approximately 2 years
|
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PK parameters such as maximum observed drug concentration (Cmax)
기간: Up to approximately 2 years
|
Applicable in Dosage escalation |
Up to approximately 2 years
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 23111-1
- 2025 (미국 NIH 보조금/계약)
- 2025-523648-11-00 (씨티스)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access. As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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