진행성 암 환자를 대상으로 한 DSB2455의 안전성, 내약성 및 활성 평가 임상시험¶

Study to Assess Safety, Tolerability and Activity of DSB2455 in Participants With Advanced Malignancies

안내

이 페이지는 자동 수집·AI 요약된 정보입니다. 의료 조언이 아니며, 치료 결정은 반드시 담당 의료진과 상의하세요. 응급 상황은 응급 가이드 또는 119.

항목	내용
등록번호	NCT06458712
상태	모집 중
단계	1상
시험 약물/중재	DSB2455
대상 질환	Advanced Cancers (Breast, Ovarian, mCRPC, Pancreatic Ductal Adenocarcinoma (PDAC), Brain Mets) With Specific Mutations (Homologous Recombination Deficiency)
스폰서	Duke Street Bio Ltd
연령·성별	18 Years ~ 제한 없음 · ALL
목표 인원	180
시작 / 1차 완료 예정	2024-11-21 / 2028-08
국내 실시기관	없음
실시 국가	5개국, 기관 21곳 (France, Hungary, Poland, Spain, United States)
결과 게시	아니오
최근 갱신	2026-09-02

문의처 (등록된 중앙 연락처)¶

Duke Street Bio +44 (0)203 890 8710 clinicaltrials@dukesb.com

국내 기관 참여 문의는 해당 병원 임상시험센터 또는 담당 주치의를 통해 하세요. 참여 방법 안내

시험 개요¶

이 임상시험은 특정 유전자 변이(동일계열 재조합 결핍, Homologous Recombination Deficiency)가 있는 진행성 암 환자를 대상으로 신약 DSB2455의 안전성과 내약성을 평가합니다. 췌장암 환자 중 췌장관선암(Pancreatic Ductal Adenocarcinoma, PDAC) 환자도 대상에 포함됩니다. 연구는 용량 증량(Dose Escalation) 단계와 용량 확장(Dose Expansion) 단계로 나누어 진행됩니다. 목표 환자 수는 총 180명입니다.

목표 인원은 총 180명입니다.
단계는 1상(Phase Ia/b) 임상시험입니다.
대상 질환에는 췌장관선암(PDAC)이 포함됩니다.

참여 조건 (AI 정리, 원문 확인 필요)¶

선정 기준: - 만 18세 이상 성인 환자. - 프로토콜에 정의된 유전자 변이가 확인된 국소 진행성 및/또는 전이성 췌장관선암(PDAC) 진단. - ECOG 수행능력 평가 0에서 1. - 예상 여명 12주 초과. - 프로토콜에 따른 적절한 장기 기능 보유. 제외 기준: - 골수형성이상증후군(MDS) 또는 급성 골수성 백혈병(AML) 이력. - 이전에 PARP1 선택적 억제제를 투여받은 이력. - 연구 치료제 첫 투여 전 2주에서 4주 이내에 전신 항암 치료를 받은 경우. - 조절되지 않는 감염성 질환 또는 활동성 감염이 있는 경우.

선정/제외 기준 원문 (영어)

Inclusion Criteria:

The participant (or legally acceptable representative, if applicable) provides written informed consent for the study.
Aged ≥18 years of age on the day of signing the informed consent.
Histologically confirmed diagnosis of locally advanced and/or metastatic breast cancer, prostate cancer (mCRPC), ovarian cancer, or pancreatic ductal adenocarcinoma (PDAC) with confirmed gene alterations/ mutations as defined in the protocol
Has received prior cancer treatment as outlined in the protocol
Has measurable disease per RECIST v1.1, or non-measurable disease as defined in the protocol.
ECOG performance status of 0 to 1.
Life expectancy >12 weeks.
Adequate organ function as defined in the protocol.
Willing and able to comply with scheduled visits (including follow-up visits), and protocol procedures.
Willing and able to undergo imaging procedures as per protocol.
Willing to provide blood samples for correlative research purposes.
Able to swallow oral medication as an intact dosage form.
Prior intervention with an approved non-selective PARP inhibitor is permitted in Dose Escalation only.
Has received prior cancer treatment as outlined in the protocol, dependent on disease type.
Known asymptomatic or symptomatic brain metastasis, as confirmed by an MRI brain scan, from a primary tumour and meeting the eligibility for the disease types noted above (Dose Expansion only, specific Cohort).

Exclusion Criteria:

Myelodysplastic syndrome (MDS), acute myeloid leukaemia (AML) or features suggestive of MDS/AML.
Has received a prior PARP1-selective inhibitor.
Has received prior systemic anti-cancer therapy including investigational agents or device within 2 or 4 weeks prior to study intervention, dependent on the treatment.
Received prior radiotherapy within 2 weeks of the start of study intervention or has a history of radiation pneumonitis.
Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy (exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention. Note: administration of killed vaccines are allowed.
Has had an allogeneic tissue/solid organ transplant.
Has an active autoimmune disease that has required systemic intervention in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
History of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
Refractory nausea and vomiting, impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drugs.
Undergone major surgery, open biopsy or significant traumatic injury ≤28 days prior to starting study intervention.
Has an active infection requiring systemic therapy or an uncontrolled concurrent illness.
Known history of human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by the local health authority.
Known history of Hepatitis B or known active Hepatitis C virus (HCV)
Cirrhosis of the liver.
Clinically significant pulmonary illness.
Impaired cardiac function or clinically significant cardiac disease.
Participants with a healing, serious or open wound, ulcer, or bone fracture within 28 days prior to first dose of study intervention.
History or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participants involvement for the full duration of the study.
A WOCBP who has a positive urine pregnancy test (within 72 hours) prior to starting the study intervention. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
Weight loss of >5% in the 8-week period prior to starting study intervention.
Known allergy or hypersensitivity to any of the formulation components of DSB2455.
Has received radiation therapy to the lung that is >30Gy within 6 months of the first dose of study intervention.
Other disease-specific criteria as outlined in the protocol.

출처: ClinicalTrials.gov · 수집 2026-10-06 · 갱신 2026-10-06

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