진행성 고형암 및 다발골수종 환자 대상 QXL138AM의 안전성, 약동학 및 유효성 평가 1상 임상시험¶
Safety, PK and Efficacy of QXL138AM in Patients With Solid Tumors and Multiple Myeloma
안내
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| 항목 | 내용 |
|---|---|
| 등록번호 | NCT06582017 |
| 상태 | 모집 중 |
| 단계 | 1상 |
| 시험 약물/중재 | QXL138AM Injection every 2 weeks by IV Infusion |
| 대상 질환 | Ovarian Cancer, Pancreas Cancer, Urothelial Carcinoma, Renal Cell Carcinoma, Hepatocellular Carcinoma, Gastrointestinal Cancer |
| 스폰서 | Nammi Therapeutics Inc |
| 연령·성별 | 18 Years ~ 제한 없음 · ALL |
| 목표 인원 | 100 |
| 시작 / 1차 완료 예정 | 2024-08-28 / 2027-12-31 |
| 국내 실시기관 | 없음 |
| 실시 국가 | 1개국, 기관 10곳 (United States) |
| 결과 게시 | 아니오 |
| 최근 갱신 | 2026-08-27 |
문의처 (등록된 중앙 연락처)¶
- David Stover, PhD 818-926-3428 David.Stover@nammirx.com
국내 기관 참여 문의는 해당 병원 임상시험센터 또는 담당 주치의를 통해 하세요. 참여 방법 안내
시험 개요¶
본 연구는 국소 진행성 절제 불가능 및/또는 전이성 고형암 및 다발골수종 환자를 대상으로 신약 QXL138AM을 정맥 주사로 투여하는 최초 인체 적용(first in human) 1a/1b상 임상시험입니다. 연구는 용량 증량(Dose Escalation) 단계와 용량 팽창(Dose Expansion) 단계로 나누어 진행됩니다. 대상 질환에는 췌장암(pancreas cancer)을 포함한 고형암과 다발골수종이 포함됩니다. 총 목표 인원은 100명이며, 초록에 최종 결과나 생존기간 수치는 명시되지 않았습니다.
- 임상시험 단계: 1상 (PHASE1)
- 목표 인원: 100명 (국내 기관: 0곳)
- 중재 방법: QXL138AM 2주 간격 정맥 주사 (IV Infusion)
- 대상 질환: 췌장암을 포함한 진행성 고형암 및 다발골수종
참여 조건 (AI 정리, 원문 확인 필요)¶
선정 기준: - 난소암, 췌장암, 요로상피암, 신세포암, 간세포암, 위장관암, 폐암, 전립선암, 유방암 등 진행성, 절제 불가능 또는 전이성 고형암 진단 환자 - 표준 치료에도 불구하고 진행되었거나, 연구자의 판단에 따라 기존 치료가 효과 없거나 감내하기 힘든 환자 - 18세 이상의 남성 또는 여성 - 동유럽종양학협력그룹(ECOG) 수행능력 평가 0, 1, 또는 2 - RECIST 버전 1.1에 따른 측정 가능한 병변이 최소 1개 이상 있는 환자 (고형암 한정)
제외 기준: - 뉴욕심장협회(NYHA) 등급 III 또는 IV의 심장 질환, 최근 6개월 이내 심근경색, 불안정성 부정맥 등 심혈관 질환 - 전신 치료가 필요한 활동성 및 조절되지 않는 감염 - QXL138AM 성분(anti-CD138 IgG1 항체, Interferon A2a 등)에 대한 과민반응 - 임신 중이거나 수유 중인 여성 - 첫 투여 전 28일 또는 반감기의 5배 기간 이내에 이전 항암 치료를 받은 경우
선정/제외 기준 원문 (영어)
Inclusion Criteria:
-
Participants with Solid Tumors
-
Histopathologically confirmed diagnosis of an advanced, unresectable, or metastatic solid tumor (ovarian, pancreatic, urothelial, renal, hepatocellular, gastrointestinal (GI), lung, prostate, and breast cancer).
- Have progressed despite standard therapies, or for whom conventional therapy is not effective or tolerable, as judged by the Investigator. Patients must have no available therapeutic options known to confer clinical benefit for their tumor type.
-
Participants with Multiple Myeloma
-
Have progressed despite standard therapies, or for whom conventional therapy is not effective or tolerable, as judged by the Investigator.
- Patients must have failed at least 3 prior therapies for myeloma and should have had prior exposure to a proteosome inhibitor, an IMiD, and an anti-CD38-directed therapy.
2. Male or female participants ≥18 years of age at the time of informed consent 3. An Eastern Cooperative Oncology Group (ECOG) performance status scale of 0, 1, or 2 at Screening 4. Must have at least 1 measurable lesion by RECIST version 1.1 (solid tumors only), or evaluable disease by IMWG Uniform Response Criteria (multiple myeloma only) 5. Adequate organ function and bone marrow reserve 6. Adequate cardiac function as estimated by left ventricular ejection fraction 7. Female participants of child-bearing potential must:
- Have a negative serum pregnancy test at screening and a negative pregnancy test at Week 1 Day 1 prior to first dose of QXL138AM, AND
- Agree to use at least 1 highly effective method of contraception for the duration of study participation, and for 120 days after last dose of QXL138AM.
8. Male participants of child-bearing potential must: * Agree to use at least 1 highly effective method of contraception for the duration of study participation, and for 120 days after last dose of QXL138AM, AND * Refrain from sperm donation prior to the first dose of investigational product through 120 days following the last dose of QXL138AM.
Exclusion Criteria:
- New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, a history of risk factors for Torsades de Pointes (TdP), including heart failure, hypokalemia, and family history of long QTc syndrome, or evidence of ischemia on ECG.
Symptomatic ischemic heart disease or unstable angina pectoris; or history of cardiac angioplasty, cardiac stenting, or coronary artery bypass graft. A clinically significant baseline prolongation of QT/QTcF interval at screening. 2. The use of concomitant medications that may significantly prolong the QT/QTc interval. 3. Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy. 4. Known hypersensitivity to the investigational product or components (anti-CD138 IgG1 antibody, Interferon A2a and/or the formulation excipients: histidine, sucrose, arginine, polysorbate 80). 5. Female participant is lactating. 6. Any other clinically significant comorbidities. 7. Received prior anticancer therapy within 28 days or 5x the half-life (whichever is shorter) prior to the first dose of investigational product. 8. Participants who received wide-field radiation therapy within 4 weeks prior to first dose of investigational product, (2 weeks for limited field radiation therapy) 9. Major surgery within 30 days before first dose of investigational product 10. Chronic use of systemic corticosteroids of more than 20 mg/day of prednisone or equivalent. 11. Active, clinically significant liver disease such as Hepatitis B or C, autoimmune hepatitis, or cirrhosis (Child Hugh Stage B or C). 12. Current or history of mood disorder such as major depression per DSM-5 within past two years not controlled with current therapy. 13. Active autoimmune disorders not controlled with current therapy. 14. Active endocrine disorders including hypothyroidism, hyperthyroidism, hypoglycemia, hyperglycemia, and diabetes mellitus not controlled with current therapy.
출처: ClinicalTrials.gov · 수집 2026-10-06 · 갱신 2026-10-06
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