NL-OMON52063招募中不适用
A Phase 1a/1b Study Exploring the Safety and Tolerability of INCB081776 in Participants With Advanced Malignancies - INCB 81776-101
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
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 99（—）
入选标准
- •1. Participant must be >= 18 years of age at the time of signing the ICF.
- •2. Participant (or legally acceptable representative if applicable) provides
- •written informed consent for the study.
- •3. Must be willing and able to conform to and comply with all protocol
- •requirements,
- •including, all scheduled visits, protocol procedures, and the ability to
- •swallow oral capsules.
- •4. Part 1A, 1B, 2A, and 2B: Histologic or cytologic evidence of a solid
- •neoplasm for
- •which no standard therapy is available, or have progressed despite standard
- •therapy or are
- •intolerant to standard therapy, which may include chemotherapy, targeted
- •biological therapy, and immunotherapy, inclusive of the cohort-specific
- •requirements
- •outlined below:
- •Measurable lesions per RECIST v1.1 that are considered nonamenable to surgery
- •or other curative treatments or procedures, with at least 1 target lesion
- •available for evaluation. Tumor lesions located in a previously irradiated area
- •or in an area subjected to other loco-regional therapy are considered
- •measureable if progression has been demonstrated in the lesion.
- •Part 1A and Part 2A only:
- •* Histologically confirmed advanced and/or metastatic solid tumors that are
- •considered unresectable and may include but are not limited to the following
- •tumor types: gastric or GEJ adenocarcinoma, HCC, melanoma, NSCLC, RCC,
- •soft-tissue sarcoma, SCCHN (recurrent or metastatic), TNBC, or urothelial
- •carcinoma. Additionally, MSI-H tumors are included in this part.
- •Part 1B and 2B only:
- •* Cohort 1: advanced or metastatic melanoma
- •* Must have received available SOC, including but not limited to 1 prior
- •PD-1/L1 containing regimen (either as a single agent or in combination),
- •received at least 2 doses of the anti-PD-1/L1 agent, and experienced PD during
- •or after treatment.
- •* Known BRAF status (V600e and V600k).
- •* Ocular melanoma is excluded.
- •* Cohort 2: advanced or metastatic NSCLC
- •* Must have received available SOC, including but not limited to 1 prior
- •PD-1/L1 containing regimen (either as a single agent or in combination),
- •received at least 2 doses of the anti-PD-1/L1 agent, and experienced PD during
- •or after treatment.
- •* Participants with tumors harboring known driver mutations (EGFR, ALK, ROS1,
- •BRAF) who have previously been treated with appropriate targeted agents are
- •allowed to enroll.
- •* Known PD-L1 expression status and/or TPS
- •* Cohort 3: recurrent or metastatic SCCHN
- •* Must have received available SOC, including but not limited to 1 prior
- •PD-1/L1 containing regimen (either as a single agent or in combination),
- •received at least 2 doses of the anti-PD-1/L1 agent, and experienced PD during
- •or after treatment.
- •* Known PD-L1 expression status and/or TPS
- •* Carcinoma of the nasopharynx, thyroid, salivary gland, or nonsquamous
- 另有 10 项未显示
排除标准
- •1. Participants receiving potent inhibitors or inducers of CYP3A4.
- •2. Participants with macular degeneration, proliferative diabetic retinopathy
- •or diabetic
- •retinopathy with macular edema, retinal vein occlusions, uveitis, central
- •serous retinopathy, leukemic retinopathy, inherited retinal degenerations,
- •known family history of inherited retinal degenerations, and participants at
- •risk for angle closure glaucoma from pupillary dilation are ineligible.
- •Participants with other clinically significant abnormalities identified during
- •ophthalmic screening examinations that may confound ocular monitoring are
- •ineligible.
- •3. Clinically significant cardiac disease, including LVEF<40%, unstable angina,
- •myocardial infarction within 6 months of Cycle 1 Day 1, New York Heart
- •Association
- •Class III or IV congestive heart failure, and arrhythmia requiring therapy.
- •4. History or presence of an abnormal rhythm or pattern on ECG that, in the
- •investigator's
- •opinion would have a clinically meaningful impact on the study.
- •5. Untreated brain or CNS metastases or brain or CNS metastases that have
- •progressed.
- •6. Participants who have active or inactive autoimmune disease or syndrome
- •independent of prior therapy or induced by prior immune checkpoint inhibitor
- •therapy that has required systemic treatment in the past 2 years or who are
- •receiving systemic therapy for an autoimmune or inflammatory disease
- •7. Parts 1B, 2A, and 2B only: Participants with prior Grade 3 or higher
- •immune-related
- •AEs or any ocular toxicity on prior immunotherapy.
- •8. Laboratory values not within the Protocol-defined range.
- •9. Participants receiving any vitamin K antagonists,
- •10. Treatment with anticancer medications or investigational drugs within the
- •intervals before the first administration of study drug:
- •a. At least 14 days for chemotherapy, targeted small molecule therapy, or
- •therapy. Participant must not have had radiation pneumonitis as a result of
- •b. At least 28 days for a prior monoclonal antibody used for anticancer
- •11. Has not recovered to <= Grade 1 or baseline from toxic effects of prior
- •therapy (including
- •prior immunotherapy) and/or complications from prior surgical intervention.
- •12. Parts 1B, 2A, and 2B only: No use of systemic corticosteroids within 7 days
- •first dose of study treatment.
- •13. Receipt of a live vaccine within 3 months of the first dose of study
- •14. Active infection requiring systemic therapy.
- •15. Evidence of HBV or HCV infection or risk of reactivation.
- •16. Known history of HIV (HIV 1/2 antibodies).
- •17. Known hypersensitivity or severe reaction to any component of study drugs or
- •formulation components.
- •18. Is pregnant or breastfeeding or expecting to conceive or father children
- •projected duration of the study, starting with the screening visit through 190
- •the last dose of study treatment.
- •19. Any condition that would, in the investigator's judgment, interfere with
- •full participation
- •in the study, including administration of study treatment and attending
- 另有 4 项未显示
研究者
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