Trials / Completed
CompletedNCT02045368
Study of Insulin-like Growth Factor (IGF)-Methotrexate Conjugate in the Treatment of Advanced Tumors Expressing IGF-1R
STM-02: Phase I Study of IGF-Methotrexate Conjugate in the Treatment of Advanced Tumors Expressing Insulin-like Growth Factor Receptor 1 (IGF-1R)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 92 (actual)
- Sponsor
- IGF Oncology, LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase I dose escalation study will evaluate IGF-Methotrexate conjugate (765IGF-MTX) in patients with advanced, previously treated tumors. 765IGF-MTX is administered as an IV infusion over 1 hour on days 1, 8 and 15 of a 28 day cycle. Treatment continues until disease progression, unacceptable toxicity, or patient refusal. Assessment of response will be confirmed with imaging studies performed at the end of cycle 2 +/- 7 days, and every 2 weeks thereafter.
Conditions
- Breast Cancer
- Brain Cancer
- Gastrointestinal Cancers
- Genitourinary Cancers
- Gynecologic Cancers
- Head and Neck Cancers
- Melanoma
- Thoracic Cancers
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IGF-Methotrexate conjugate | IV infusion at the assigned dose administered on days 1, 8, and 15 of a 28 day (4 week) cycle. Up to 7 dose levels will be tested, starting with 0.05 microequivalents per kg and up to 2.5 microequivalents per kg. |
Timeline
- Start date
- 2014-01-28
- Primary completion
- 2016-09-30
- Completion
- 2016-09-30
- First posted
- 2014-01-24
- Last updated
- 2019-08-22
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02045368. Inclusion in this directory is not an endorsement.