Dose Escalation definition

Dose Escalation. The Phase I dose-finding will use a traditional 3+3 to determine the maximum tolerated dose (MTD), based on first cycle DLTs. A maximum of 4 dose levels of LB-100 will be explored. The determination of the recommended Phase II dose (RP2D) will be based on the MTD (and will not exceed the MTD) with additional consideration of dose modifications, adverse events in subsequent cycles, clinical activity and correlative studies. Expanded Cohort: Additional patients will be enrolled until 12 patients are treated at the proposed RP2D to help confirm the tolerability of the RP2D and obtain preliminary data on efficacy Primary endpoints: ● Determine recommended phase II dose (RP2D) of the combination using DLT (Definition Section 5.7) during the first cycle as assessed by CTCAE version 5.0 Secondary endpoints: ● Objective response rate (O▇▇) by RECIST v1.1 (Appendix B) ● Duration of overall response by RECIST v1.1 (Appendix B) ● Safety and Adverse events by assessed by CTCAE version 5.0 ● Progression-free survival (PFS) as defined by RECIST v1.1 (Appendix B) ● Overall survival, which is defined as the time from the date of study enrollment to the date of death from any cause. For patients who are still alive as of the data cutoff date, OS time will be censored on the date of the patient’s last contact (last contact for patients in post discontinuation is last known alive date in mortality status). Sample Size: Minimum=14, Maximum=36, Expected=21 Estimated Accrual Duration: 1-1.5 years Estimated Study Duration: 18 -24 months Estimated Participant Duration: 6 months ● Histologically or cytologically confirmed extensive-stage disease small cell lung carcinoma per the Veterans Administration Lung Study Group (VALG) staging system, (Appendix E) ● Measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (Appendix B) ● No prior systemic chemotherapy, immunotherapy, biological, hormonal, or investigational therapy for SCLC ● Adequate hematologic and organ function, including: Hematologic: absolute neutrophil (segmented and bands) count (ANC) ≥1.5x10/L, platelets ≥100x10/L, and hemoglobin ≥9 g/dL Hepatic: bilirubin ≤1.5 times upper limits of normal (ULN) may be enrolled, and alkaline phosphatase (AP), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 times ULN (AP, AST, and ALT ≤5 times ULN are acceptable if the liver has tumor involvement).
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Dose Escalation means sequentially administering increasing doses of an investigational drug or biologic to different cohorts of study subjects until a prespecified event occurs or the maximum desired dose is reached.
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Examples of Dose Escalation in a sentence

  • Notwithstanding Licensor’s responsibilities and decision-making rights set forth with regard to the PRC Phase I Dose Escalation Clinical Trial, the PRC Phase I Expansion Cohort Clinical Trial, and the Ex-PRC Phase I Dose Escalation Clinical Trial, Licensor agrees to consult and review with Company, through the JAC, the design of such planned Phase I Clinical Trials, and allow Company to review and comment on the respective draft protocols.

  • The Dose Escalation Phase will include two parts, Part A and Part B.

  • Notwithstanding Section 2.1, Company hereby authorizes Licensor to conduct (i) at Licensor’s cost, the Ex-PRC Phase I Dose Escalation Clinical Trial which Phase I Clinical Trial shall be performed by Licensor under Licensor’s full responsibility, and (ii) at Licensor’s cost, the Ex-PRC Phase I Expansion Cohort Clinical Trial.

  • Licensor shall have the exclusive right, and sole responsibility and decision-making authority, to Develop the Collaboration Compound and Product in the PRC and in the Territory by conducting (either itself or through its Affiliates, agents, subcontractors and/or Sublicensees) the PRC Phase I Dose Escalation Clinical Trial, the PRC Phase I Expansion Cohort Clinical Trial, and the Ex-PRC Phase I Dose Escalation Clinical Trial, at its own cost and expense.

  • Notwithstanding Section 2.1, but subject to Section 4.1, Company hereby authorizes Licensor to conduct (i) at Licensor’s cost, the Ex-PRC Phase I Dose Escalation Clinical Trial which Phase I Clinical Trial shall be performed by Licensor under Licensor’s full responsibility, and (ii) at Licensor’s cost, the Ex-PRC Phase I Expansion Cohort Clinical Trial.

  • Licensor shall have the exclusive right, and sole responsibility and decision-making authority, to Develop the Collaboration Compound and Product in the Reserved Territory and in the Company Territory by conducting (either itself or through its Affiliates, agents, subcontractors and/or Sublicensees) the PRC Phase I Dose Escalation Clinical Trial, the PRC Phase I Expansion Cohort Clinical Trial, and the Ex-PRC Phase I Dose Escalation Clinical Trial, at its own cost and expense.

  • Arcus shall have [***] days from the date of delivery to accept or reject the Dose Escalation Batch, and must state in writing the reasons each portion of the Dose Escalation Batch is rejected, if applicable.

  • Within [***] days after the later of (i) receipt of a written invoice for the Dose Escalation Batch or (ii) delivery to Arcus of the Dose Escalation Batch by WuXi, together with all batch records and a certificate of compliance, and acceptance of the Dose Escalation Batch by Arcus, which shall not be unreasonably withheld by Arcus, Arcus shall pay to WuXi a non-refundable amount of [***].

  • Upon expiration of the [***] day period, if Arcus has not rejected the Dose Escalation Batch, in whole or in part, then Arcus is deemed to have accepted the Dose Escalation Batch, and payment shall be due in accordance with this paragraph.

  • Upon conclusion of the Dose Escalation study and in accordance with Sections 6.2 and 6.3, NN shall provide and discuss with ZGEN information related to the Dose Escalation study.