Clinical trialPhase 1Terminated
Recombinant Albumin Fusion Protein sEphB4-HSA in Treating Patients With Metastatic or Recurrent Solid Tumors
A First-In-Human Phase I Study of sEphB4-HSA in Patients With Advanced Solid Tumors With Expansion at the Maximum Tolerated Dose (MTD) or Recommended Phase II Dose (RP2D).
- Outcome
- Stopped earlyLack of funding (Business decision)
- Phase
- Phase 1
- Status
- Terminated
- Study type
- Interventional
- Start
- 6 September 2012
- Ended
- 29 May 2019
- Enrollment
- 102 participants
- Sites
- 1
- Primary outcomes
- Toxicities observed at each dose level utilizing the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0; Number of patients with complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or inevaluable (IE); Survival; Time to failure
- Sponsor type
- Academic / other
- Results posted
- No
- Last update
- 24 August 2022
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Brief summary public domain (ClinicalTrials.gov)
This study is about an experimental drug called sEphB4-HSA (recombinant albumin fusion protein sEphB4-HSA). This research study will be the first time sEphB4-HSA is given to people. sEphB4-HSA prevents tumor cells from multiplying and blocks several compounds that promote the growth of blood vessels that bring nutrients to the tumor. sEphB4-HSA has shrunk colon, lung, breast, glioma, melanoma, prostate and Kaposi's sarcoma tumors in mice
Detailed description public domain (ClinicalTrials.gov)
PRIMARY OBJECTIVES: I. To establish the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of sEphB4-HSA. II. To describe the dose limiting toxicities and adverse event profile of sEphB4-HSA in patients with advanced solid tumors. III. To describe the pharmacokinetics of sEphB4-HSA. IV. To describe the anti-tumor activity of sEphB4-HSA as manifested by responses to treatment. V. To obtain preliminary evaluation of effect of sEphB4-HSA on absolute circulating tumor cell (CTC) numbers as compared with pre-treatment levels using pre- and during treatment CTC. Exploratory evaluation of effect of sEphB4-HSA on downstream protein mediators of the Ephrin pathway (pAKT, pSrc) and their transcriptional target genes (rgs5 and psenen) will be performed. VI. To collect pilot information to identify a dose or doses with biologic activity. Biologic activity after treatment with sEphB4-HSA will be defined as evidence of drug-on-target effect as manifested by reduction in absolute CTC numbers. Other exploratory evaluations of drug-on-target effect such as increase in transcript levels of psenen or rgs5 may be considered in the assessment of biologic activity. OUTLINE: This is a dose-escalation study. Patients will be assigned to receive recombinant EphB4-HSA fusion protein intravenously (IV) over 60 minutes in one of the following treatment schedules: 1. Weekly treatment - administered on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 2. Every 2 weeks treatment - administered on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 3. Every 3 weeks treatment - administered on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.