NL-OMON53794已完成不适用
A Phase 1, Open-Label, multicenter Study of INCA00186 as monotherapy or in combination with immunotherapy in participants with advanced solid tumors - INCA0186-101
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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
- •Participants are eligible to be included in the study only if all of the
- •following criteria apply:
- •1. Ability to comprehend and willingness to sign a written ICF for the study.
- •2. Male or female participant aged 18 years or older inclusive at the time of
- •signing the ICF.
- •3. Must be willing and able to conform to and comply with all Protocol
- •requirements, including all scheduled visits and Protocol procedures.
- •4. Willingness to undergo pre- and on-treatment tumor biopsy (core or
- •excisional).
- •5. Have CD8 T-cell-positive tumors based on evaluation of CD8+ T-lymphocyte
- •presence by IHC performed on pretreatment tumor biopsy tissue.
- •6. ECOG performance status 0 or 1.
- •7. Measurable disease according to RECIST v1.1.
- •8. Phase 1a early dose level cohorts in each of the treatment groups only:
- •Participants with advanced or metastatic solid tumors experiencing disease
- •progression after treatment with available therapies, including anti-PD-(L)1
- •therapy (if applicable), that are known to confer clinical
- •benefit, or who are intolerant to, or ineligible for standard treatment.
- •Prior anti-PD-(L)1 therapy should not have been discontinued because of
- •intolerance.
- •9. Participants with SCCHN:
- •a. Participants with histologically or cytologically confirmed squamous cell
- •carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx not amenable
- •to local therapy with curative intent (surgery or radiation with or without
- •chemotherapy).
- •b. Participants should have disease progression after treatment with available
- •therapies, including anti-PD-(L)1 therapy (alone or as part of a combination),
- •that are known to confer clinical benefit or who are intolerant to or
- •ineligible for standard treatment. Prior anti-PD-(L)1 therapy should not have
- •been discontinued because of intolerance.
- •10. Participants with specified GI malignancies: Histologically or
- •cytologically confirmed advanced or metastatic CRC, gastric/GEJ cancer, HCC,
- •PDAC, or SCAC.
- •a. Participants should have disease progression after treatment with available
- •therapies, including anti-PD-(L)1 therapy (if applicable), that are known to
- •confer clinical benefit or who are intolerant to or ineligible for standard
- •treatment. Prior anti-PD-(L)1 therapy should not have been discontinued because
- •of intolerance.
- •11. For participants to be enrolled in cohorts including INCB106385: The
- •ability to swallow oral medication.
- •12. Willingness to avoid pregnancy or fathering children based on the criteria
- •a. Male participants with reproductive potential must agree to take appropriate
- •precautions to avoid fathering children (with at least 99% certainty) and
- •refrain from donating sperm from screening through 190 days after the last dose
- •of study treatment. Permitted methods that are at least 99% effective in
- •preventing pregnancy should be communicated to the participants and
- •their understanding confirmed.
- •b. Female participants who are WOCBP must have a negative pregnancy test at
- •screening (serum test) and before the first dose of Day 1 (urine test) and must
- •agree to take appropriate precautions to avoid pregnancy (with at least 99%
- 另有 3 项未显示
排除标准
- •Participants are excluded from the study if any of the following criteria
- •1. Clinically significant cardiac disease, unstable angina, acute myocardial
- •infarction within 6 months of Cycle 1 Day 1, and New York Heart Association
- •Class III or IV congestive heart failure.
- •2. History or presence of an ECG abnormality that, in the investigator's
- •opinion, is clinically meaningful. For participants to be enrolled in cohorts
- •including INCB106385, screening QTcF interval > 450 milliseconds (ms) is
- •excluded; in the event that a single QTc is > 450 ms, the participant may
- •enroll if the average QTc for the 3 ECGs is < 450 ms.
- •3. Known active CNS metastases and/or carcinomatous meningitis.
- •4. Participants who have active or inactive autoimmune disease or syndrome (eg,
- •rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis,
- •inflammatory bowel disease) that has required systemic treatment in the past 2
- •years or who are receiving systemic therapy for an autoimmune or inflammatory
- •disease (ie, with use of disease modifying agents, corticosteroids, or
- •immunosuppressive drugs).
- •5. Diagnosis of immunodeficiency or is receiving chronic systemic steroid
- •therapy (doses > 10 mg daily of prednisone or equivalent) or any other form of
- •immunosuppressive therapy within 7 days before the first dose of study
- •treatment. Use of short courses of steroids for procedure
- •prophylaxis, inhaled or topical steroids, or systemic corticosteroids <= 10
- •mg/day is permitted.
- •6. Known additional malignancy that is progressing or requires active
- •treatment, or history
- •of other malignancy within 2 years of the first dose of study treatment with
- •the exception
- •of cured basal cell or squamous cell carcinoma of the skin, superficial bladder
- •prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other
- •noninvasive or
- •indolent malignancy, or cancers from which the participant has been disease
- •free > 1 year after treatment with curative intent.
- •7. Participants with exclusionary laboratory values at screening (see protocol)
- •8. Has not recovered to <= Grade 1 from toxic effects of prior therapy
- •(including prior immunotherapy) and/or complications from prior surgical
- •intervention before starting study treatment.
- •9. Evidence of interstitial lung disease, history of interstitial lung disease,
- •or active noninfectious pneumonitis.
- •10. Immune-related toxicity during prior immune therapy for which permanent
- •discontinuation of therapy is recommended (per product label or consensus
- •guidelines), OR any immune-related toxicity requiring intensive or prolonged
- •immunosuppression to manage (with the exception of endocrinopathy that is
- •well-controlled on replacement hormones).
- •11. Prior treatment with any adenosine pathway targeting drugs (eg, A2A
- •receptor and/or A2B receptor antagonists, anti-CD38, anti-CD39, anti-CD-73/CD73
- •antagonists).
- •12. Any prior chemotherapy, biological therapy, or targeted therapy to treat
- •the participant's disease within 5 half-lives or 28 days (whichever is shorter)
- •before the first dose of study treatment.
- •13. Any prior radiation therapy within 28 days before the first dose of study
- •14. Undergoing treatment with another investigational medication or having been
- 另有 1 项未显示
研究者
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