CTIS2023-509230-19-00进行中（未招募）1 期
A first-in-human, Phase 1/2, open-label, multi-center, dose-escalation, dose-optimization, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of PARP1 selective inhibitor, IMP1734, in patients with advanced solid tumors - EIK1003-001
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 272
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Participants must voluntarily participate and comply with study procedures, Female Participants should meet = 1 of the following criteria: a. Lack of childbearing potential b. Post-menopausal c. For those with childbearing potential, have a negative pregnancy test at screening, not be in lactation, and willing to take highly effective contraceptive, Male participants had a vasectomy or use highly effective methods of (from day-0 to 6 months after last dose of IMP), Both PARPi-treated and PARPi-naïve participants are eligible. For PARPi-treated participants, up to 1 prior PARPi containing treatment is allowed (Pt 1 only), Participants with EOC, fallopian tube, or primary peritoneal cancer must have received 1 and only 1 prior PARPi containing treatment (Pt2 only), Participants with EOC, fallopian tube, or primary peritoneal cancer should be platinum sensitive (Pt3 only), Breast cancer participants are eligible provided no evidence of progression. Participants who previously received platinum-based chemotherapy as neo-adjuvant/adjuvant are eligible provided at least 12 months, between this treatment, and 1st dose of IMP (Pt3 only), No prior therapy with a PARPi (Pt3 Cohort 3A only), Received 1 and only 1 prior PARPi (Pt3 Cohort 3B only), Participants must be = 18 years of age, Participants must have 1 of the following: a. Confirmed advanced/recurrent/metastatic, endometrioid EOC, fallopian tube or primary peritoneal cancer (Cohorts-1A/C, Pt2/3), and: i. Must received = 1 prior chemotherapy for advanced disease ii. Must be platinum resistant (Cohort-1C only) iii. Should have evaluable disease as defined: a. = 1 measurable lesion per RECIST v1.1 and/or b. CA125 evaluable b. Confirmed advanced/recurrent/metastatic HER2-neg adenocarcinoma of the breast and (Cohort-1A/C and Pt3): i. Must have received = 1 prior chemotherapy ii. Participants with HR+ must have received hormonal therapy iii. Should have evaluable disease defined as = 1 measurable lesion c. Confirmed adenocarcinoma mPC (Cohort-1A/1B and Pt3): i. mCRPC: With ongoing ADT within 28 days before study start. Participants receiving ADT should continue treatment during the study ii. mCSPC (Cohort-1B only) Candidates for ADT and/or started ADT but no longer than 12 weeks before study start or with bilateral orchiectomy iii. Prior therapies: a. Must have received a novel hormonal agent (Cohort-1A and Pt3:mCRPC) b. Must have received up to 1 prior taxane based chemotherapy/ineligible for chemotherapy (Cohort1A, Pt3; mCRPC) c. May have received up to one prior therapy with an NHA and/or PARPi or taxane treatment (Cohort1B; mCRPC) iv. Should have evaluable disease defined as (Cohort1A/1B and Pt3): a) = 1 measurable lesion per RECIST v1.1, AND/OR b) = 1 evaluable lesion documented by positive bone scan c) PSA evaluable defined as a serum PSA = 1 ng/mL during screening d) Histologically/cytologically confirmed advanced/recurrent/ mPDAC (Cohort-1A) i. Must have received an appropriate prior regimen per Investigator ii. Should have evaluable disease defined as = 1 measurable lesion per RECIST v1.1, Participants are required to have deleterious or suspected deleterious germline or somatic mutations (Cohort-1A/1B and Pt3), Participants with RECIST v1.1-evaluable disease must have documented radiological progressive cancer before study entry. Prostate cancer participants whose is limited to regional pelvic lymph nodes/local recurrence, not eligible, For prostate cancer, PSA progress
排除标准
- •Any participants treated with anti-cancer therapies, Any major illness that will substantially increase the risk associated with the patient’s participation in this study, Participants with a diagnosis of MDS or AML or have received transplantation, Participants with any known predisposition to bleeding, Live/attenuated vaccine within 28 days prior to the 1st dose of IMP, COVID-19 vaccine within 72 hours prior to 1st dose of IMP, Participants with administration of any strong inhibitors/inducers of CYP3A4 or P-gp inhibitors within 28 days or 5 half-lives (whichever is shorter) prior to the 1st dose of the IMP, Participants who may need continuous treatment with PPIs or P-CABs or H2-blockers during the study period, Receiving continuous prednisone or equivalent, Participants with a known history of hypersensitivity to the IMP or its ingredients., Participants unable to swallow oral medications OR have malabsorption syndrome/uncontrolled GI condition, Participants that received prior PARP1-selective inhibitors, Female Participants who are pregnant or lactating/breastfeeding, Participants with known history of alcoholism/drug abuse, Participants who have participated in another clinical study with an IMP administered in the last 28 days or five half-lives (whichever is shorter), Have used an investigational device within 28 days prior to the first dose of IMP, Cohort 1B only (mCSPC): Must not received prior treatment with 2nd generation or investigational AR, or CYP17 enzyme inhibitors, Cohort 1C only: Participants with = Grade 2 peripheral neuropathy at time of screening, Participants who have undergone: major surgery, extensive field radiotherapy, palliative radiotherapy OR used a radioactive drug, Participants with other malignancies requiring treatment within 2 years before 1st dose of IMP, Participants previous treatment-related toxicities that have not recovered, i.e., to = Grade 1, as evaluated by NCI-CTCAE or baseline (Grade 2 and other non clinically significant toxicities can be enrolled), Participants with active CNS metastases and/or carcinomatous meningitis., Participants with any of the following cardiac criteria: a. mean resting QTcF > 470 ms or QTcF < 340 ms; b. any factors that increase the risk of QT prolongation, or use of concomitant drugs that may prolong/shorten QT and at risk of Torsades de Pointes; c. any clinically important abnormalities of resting ECG, Participants with other cardiovascular diseases as defined by any of the following: a. symptomatic heart failure b. uncontrolled hypertension c. hypertensive heart disease d. acute coronary syndrome/acute myocardial infarction, unstable angina pectoris, coronary intervention procedure e. cardiomyopathy f. presence of clinically significant valvular heart disease g. history of arrhythmia requiring treatment; Participants with atrial fibrillation and optimally controlled ventricular rate are permitted h. stroke within 6 months prior to screening i. Participants with symptomatic hypotension at screening, Participants with infections, including: a. An uncontrolled acute infection, an active infection requiring systemic treatment, prophylactic use of systemic antibiotics is allowed b. HIV-infected participants must have well-controlled HIV and be on ART defined as: i. must have a CD4+ T-cell count = 350 cells/mm3 at screening, ii. must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 copies/mL or the LLOQ iii. must not
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