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AVID100 in Advanced Epithelial Carcinomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03094169
Recruitment Status : Recruiting
First Posted : March 29, 2017
Last Update Posted : March 19, 2018
Information provided by (Responsible Party):
Formation Biologics

Brief Summary:
Approximately 80 male and female patients with documented solid tumor malignancies of epithelial origin that are locally advanced or metastatic, and either refractory to standard therapy or for whom no standard therapy is available, will be entered into this Phase 1a/2a, multicenter, open-label, dose-escalation, cohort study of AVID100.

Condition or disease Intervention/treatment Phase
Solid Tumor, Adult Drug: AVID100 IV Phase 1

Detailed Description:

On Day 1 of study, patients will receive study drug administered by 1-hour IV infusion in a fixed 100 mL volume. AVID100 will be administered once every 3 weeks (Q3W) with administration on Day 1 of the first week, followed by a 3-week recovery period.

Evidence of progressive disease at any point in the study will necessitate withdrawal of the patient from further participation so that alternative management of their malignancy may be considered.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Uncontrolled, open label, non-randomized, Enrollment in the order of confirmation of eligibility, Escalating doses of study drug in sequential patient cohorts (Phase 1a).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1a/2a Dose Escalation Trial to Determine Safety, Tolerance, MTD, and Preliminary Antineoplastic Activity of AVID100, in Patients With Advanced or Metastatic Solid Tumors of Epithelial Origin
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : August 1, 2019

Arm Intervention/treatment
Experimental: Dose escalation
Minimum of 1 to 3 patients per dose cohort; approximately 4 dose cohorts to be evaluated to establish the Maximum tolerated dose.
Drug: AVID100 IV
AVID100 is administered once every 3 weeks

Primary Outcome Measures :
  1. Determine safety and tolerability of AVID100 [ Time Frame: 6 months ]
    Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment

Secondary Outcome Measures :
  1. PK Profile of Total Antibody [ Time Frame: 9 months ]
    Characterization of the pharmacokinetic profile of total antibody

  2. Evaluation of the preliminary anti-neoplastic effects of AVID100 [ Time Frame: 9 months ]
    Number of Participants with evidence of objective response or stable disease and duration of response

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria (Phase 1):

  1. Patients with a documented (histologically- or cytologically-proven) solid tumor epithelial carcinoma that is locally advanced or metastatic
  2. Patients with a malignancy that is either refractory to standard therapy, or for which no standard therapy is available
  3. Patients with a malignancy that is currently not amenable to surgical intervention due to either medical contraindications or non-resectability of the tumor
  4. Phase 1a Dose-Escalation Cohorts: Patients with measurable or non-measurable disease according to RECIST, v1.1 criteria. To include patients reasonably likely to express EGFR.

Patients to be Excluded (patients must not meet any of the following criteria Phase 1 only)

  1. Women who are pregnant or lactating. Women of child-bearing potential (WOCBP) and fertile men with WOCBP partner(s), not using and not willing to use a medically effective method of contraception.
  2. Patients with known central nervous system (CNS) or leptomeningeal metastases, or spinal cord compression not controlled by prior surgery or radiotherapy, or patients with symptoms suggesting CNS involvement for which treatment is required
  3. Patients with a malignancy other than that of epithelial origin
  4. Patients with hematologic abnormalities at baseline
  5. Patients with a significant cardiovascular disease or condition
  6. Patients with a significant ocular disease or condition
  7. Patients with a significant pulmonary disease or condition
  8. History of pneumonia within 6 months prior to the first study drug administration
  9. Patients with significant gastrointestinal (GI) abnormalities
  10. Patients with non-healing wounds on any part of the body

Drugs and Other Treatments to be Excluded

  1. Any antineoplastic agent for the primary malignancy (standard or investigational), without delayed toxicity, within 4 weeks, 5 plasma half-lives, or twice the duration of the biological effect, whichever is shortest, prior to first study drug administration and during study with the exception of: Nitrosoureas and nitrogen mustard within 6 weeks prior to first study drug administration and during study
  2. Any other investigational treatments during study. This includes participation in any medical device or other therapeutic intervention clinical trials.
  3. Radiotherapy for target lesions within 4 weeks prior to first study drug administration and during study
  4. Herbal preparations or related over-the-counter (OTC) preparations/supplements containing herbal ingredients aimed at treating the underlying malignancy within 2 weeks prior to first study drug administration and during study
  5. Strong inhibitors and/or inducers of cytochrome P450 (CYP) isoenzyme 3A4 within 2 weeks prior to first study drug administration and during study
  6. Immunosuppressive or systemic hormonal therapy within 2 weeks prior to first study drug administration and during study.
  7. Prophylactic use of hematopoietic growth factors within 1 week prior to first study drug administration and during Cycle 1 of study; thereafter prophylactic use of growth factors is allowed as clinically indicated

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03094169

Contact: Sandra Sinclair, MHA/ED, RN 832-622-1699

United States, Michigan
START Midwest Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Yvette C Cole, RN    616-954-5554   
Principal Investigator: Nehal Lakhani, MD         
United States, Texas
South Texas Accelerated Research Therapeutics Recruiting
San Antonio, Texas, United States, 78229
Contact: Isabel Jimenez, MSN, RN    210-593-5252   
Sub-Investigator: Muralidhar Beeram, MD         
Principal Investigator: Kyriakos Papadopoulos, MD         
Sub-Investigator: Amita Patnaik, MD         
Sub-Investigator: Drew W Rasco, MD         
Sub-Investigator: Lon S Smith, MD         
Sponsors and Collaborators
Formation Biologics
Principal Investigator: Kyriakos W Popadopoulos, MD Phase 1 Principal Investigator

Responsible Party: Formation Biologics Identifier: NCT03094169     History of Changes
Other Study ID Numbers: AVID100-01
First Posted: March 29, 2017    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No