Phase I Solid Tumor Sample Clauses

Phase I Solid Tumor. VTX-2337 Monotherapy (VRXP-A101) VTX-2337 was first evaluated clinically as a stand-alone agent in a Phase I standard dose- escalation study to assess the safety, tolerability and biological activity of the compound in late- stage cancer patients. At doses ranging from 0.1–3.9 mg/m2, VTX-2337 was well tolerated overall, with the predominant adverse events being transient grade 1 or 2 fever, chills, flu-like symptoms, nausea and vomiting, anorexia, and injection site reaction. No significant drug-related hematologic, gastrointestinal, neurologic or cardiac toxicities were observed. At the highest dose evaluated, 3.9 mg/m2 (cohort 8; n=8) a single subject experienced a dose-limiting toxicity (DLT) of grade 3 hypotension associated with grade 2 cytokine release syndrome (CRS), from which the subject recovered completely. Accordingly, the maximum dose evaluated in this study (3.9 mg/m2) was adequately well tolerated. Overall, VTX-2337 was found to be well tolerated when administered subcutaneously weekly for 3 weeks of a 4-week cycle. The PK of VTX-2337 were assessed in all subjects (n=33) and demonstrated dose-dependent exposure. With subcutaneous administration, VTX-2337 was rapidly absorbed into systemic circulation as well as rapidly cleared, with mean Tmax ranging from 0.5–0.7 hours and t½ ranging from 1.7–7.1 hours. Peak plasma levels and total systemic exposure were generally dose- proportional. The biological activity (cytokines, chemokines and other inflammatory markers, including those indicative of TLR8 activation) of VTX-2337 was assessed in all subjects. Biological activity of VTX-2337 was shown to be dose dependent, with the robust induction of multiple inflammatory markers in all subjects receiving doses ≥ 2.0 mg/m2. Clinical responses were assessed by response evaluation criteria in solid tumors (RECIST) at 8 weeks. No complete responses (CR) or partial responses (PR) were seen in the study, but approximately 25% of subjects had evidence of stable disease (SD) at 8 weeks. It should be noted that VTX-2337 is anticipated to have stand-alone biological activity, but is not anticipated to induce a CR or PR as a single agent. The doses selected from this study to be used in combination studies were 2.5, 3.0, and
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  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • Clinical 2.1 Provides comprehensive evidence based nursing care to patients including assessment, intervention and evaluation.

  • Study An application for leave of absence for professional study must be supported by a written statement indicating what study or research is to be undertaken, or, if applicable, what subjects are to be studied and at what institutions.

  • First sampling In the first sampling four lamps are selected at random. The first sample of two is marked A, the second sample of two is marked B.

  • Studies The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by the Company or its subsidiaries that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus were and, if still pending, are being conducted in accordance in all material respects with all statutes, laws, rules and regulations, as applicable (including, without limitation, those administered by the FDA or by any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA). The descriptions of the results of such studies and tests that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus are accurate and complete in all material respects and fairly present the published data derived from such studies and tests, and each of the Company and its subsidiaries has no knowledge of other studies or tests the results of which are materially inconsistent with or otherwise call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus. Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, neither the Company nor its subsidiaries has received any notices or other correspondence from the FDA or any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA with respect to any ongoing clinical or pre-clinical studies or tests requiring the termination or suspension of such studies or tests. For the avoidance of doubt, the Company makes no representation or warranty that the results of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company will be sufficient to obtain governmental approval from the FDA or any foreign, state or local governmental body exercising comparable authority.

  • Biological Samples If so specified in the Protocol, Institution and Principal Investigator may collect and provide to Sponsor or its designee Biological Samples (“Biological Samples”). 12.2.

  • Random Drug Testing All employees covered by this Agreement shall be subject to random drug testing in accordance with Appendix D.

  • Human Leukocyte Antigen Testing This plan covers human leukocyte antigen testing for A, B, and DR antigens once per member per lifetime to establish a member’s bone marrow transplantation donor suitability in accordance with R.I. General Law §27-20-36. The testing must be performed in a facility that is: • accredited by the American Association of Blood Banks or its successors; and • licensed under the Clinical Laboratory Improvement Act as it may be amended from time to time. At the time of testing, the person being tested must complete and sign an informed consent form that also authorizes the results of the test to be used for participation in the National Marrow Donor program.

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • Programming Phase 2.2.1.2. Schematic Design Phase: 2.2.1.3. Design Development Phase:

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