Study Summary
This trial will test a new molecule to target cancer cells and enhance cancer-fighting NK/T-cells. It has two phases, testing in patients with solid tumors. A combo therapy will be used.
- Solid Tumors, Adult
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 11 Secondary · Reporting Duration: From time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months.
Trial Safety
Safety Progress
Trial Design
10 Treatment Groups
Combination Escalation with DF9001 and nivolumab
1 of 10
Monotherapy DF9001 Expansion in Colorectal Cancer
1 of 10
Combination PK/PD Expansion with DF9001 and nivolumab
1 of 10
Monotherapy DF9001 Expansion in Non-small Cell Lung Cancer
1 of 10
Combination Expansion of DF9001 and nivolumab in Head and Neck Squamous Cell Car...
1 of 10
Monotherapy DF9001 Expansion in Head and Neck Squamous Cell Carcinoma
1 of 10
Combination Expansion of DF9001 and nivolumab in Non-Small Cell Lung Cancer
1 of 10
Combination Expansion of DF9001 and nivolumab in Colorectal Cancer
1 of 10
Monotherapy DF9001 PK/PD Expansion
1 of 10
Monotherapy DF9001 Dose Escalation
1 of 10
Experimental Treatment
362 Total Participants · 10 Treatment Groups
Primary Treatment: Combination Escalation with DF9001 and nivolumab · No Placebo Group · Phase 1 & 2
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
Are we still looking for more people to participate in this experiment?
"According to the latest information found on clinicaltrials.gov, this particular trial is not looking for new patients at this time. The posting date was October 1st, 2022 with the most recent update taking place on October 24th, 2022. There are over 2500 other trials that are currently seeking candidates." - Anonymous Online Contributor
What is the primary goal of this research?
"The purpose of this study is to assess the overall response rate in patients receiving DF9001 in combination with nivolumab. Secondary objectives include characterizing the pharmacodynamic profile of DF9001 and measuring changes in immune cell activation, assessing the best overall response by IERC, and determining the number, severity, and duration of treatment-related adverse events according to NCI-CTCAE v5.0." - Anonymous Online Contributor