- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03834662
A Trial of AVID200, a Transforming Growth Factor β (TGFβ) Inhibitor, in Patients Malignancies
A Phase 1 Cohort Dose-Escalation Trial of AVID200, a Transforming Growth Factor β (TGFβ) Inhibitor, in Patients With Advanced or Metastatic Solid Tumor Malignancies
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Toronto, Canada, M5G 1Z5
- Princess Margaret Cancer Centre
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Michigan
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Grand Rapids, Michigan, United States, 49546
- START Midwest Clinic
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Texas
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Houston, Texas, United States, 77030
- MD Anderson Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with a documented (histologically or cytologically proven) solid tumor malignancy that is locally advanced or metastatic
- Patients with a malignancy that is currently not amenable to surgical intervention due to either medical contraindications or non-resectability of the tumor
- Patients with a malignancy that is either refractory to, or the patient is intolerant of existing therapy(ies) known to provide clinical benefit, or for which no standard therapy is available
- Patients with measurable or non-measurable disease according to RECIST, v1.1
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 (or equivalent Karnofsky PS), and anticipated life expectancy of ≥ 3 months
- Patients and their partners who are either not of childbearing potential or who agree to use a highly effective, non-hormonal, method of contraception during the study and continuing until 4 months after the last dose of study drug); male patients agreeing to refrain from sperm donation during this period.
- Patients with the ability to understand and give written informed consent for participation
Exclusion Criteria:
Patients with an active second malignancy or history of another malignancy within the last 2 years with the exception of:
- Treated non-melanoma skin cancers
- Treated carcinoma in situ (CIS) of the breast, cervix, bladder, colon, endometrium, skin (melanoma) provided complete response (CR) was achieved at least 2 years prior to study and no additional therapy is ongoing or required during study period with the exception of anti-estrogen/androgen therapy or bisphosphonates
- Controlled, superficial carcinoma of the bladder
- T1a carcinoma of the prostate comprising < 5% of resected tissue and prostate specific antigen (PSA) within normal limits (WNL) since resection
Any antineoplastic agent for the primary malignancy (standard or investigational), without delayed toxicity, within 4 weeks or 5 plasma half-lives, whichever is shortest, prior to C1/D1 and during study with the exception of:
-Nitrosoureas and mitomycin C within 6 weeks prior to C1/D1 and during study
- Any other investigational treatments within 4 weeks prior to and during study; includes participation in any medical device or supportive care therapeutic intervention trials
- Radiotherapy for target lesions within 4 weeks prior to C1/D1 and during study; radiotherapy for non-target lesions within 2 weeks prior to C1/D1
- Radiotherapy within 2 weeks prior to C1/D1 and during study. Patients must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
- Use of live vaccines against infectious diseases 4 weeks prior to C1/D1 and during study
- Immunosuppressive or systemic hormonal therapy (> 10 mg daily prednisone or equivalent) within 2 weeks prior to C1/D1 and during study
- Prophylactic use of hematopoietic growth factors within 2 weeks prior to C1/D1 and during Cycle 1 of study; thereafter prophylactic use of growth factors is allowed as clinically indicated
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SEQUENTIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Dose Level 1: 180 mg/m2 of AVID200
Intravenous infusion of AVID200 over 1 hour administered every three weeks.
Starting dose for dose escalation.
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A TGFβ receptor ectodomain-IgG Fc fusion protein inhibitor of TGFβ
Other Names:
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EXPERIMENTAL: Dose Level 2: 550 mg/m2 of AVID200
Intravenous infusion of AVID200 over 1 hour administered every three weeks.
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A TGFβ receptor ectodomain-IgG Fc fusion protein inhibitor of TGFβ
Other Names:
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EXPERIMENTAL: Dose Level 3: 1100 mg/m2
Intravenous infusion of AVID200 over 1.5 hours administered every three weeks.
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A TGFβ receptor ectodomain-IgG Fc fusion protein inhibitor of TGFβ
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Incidence of Treatment-Emergent Adverse Events
Time Frame: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, for up to 24 months
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Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
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From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, for up to 24 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Paul I Nadler, MD, Forbius (Formation Biologics)
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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