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Combination Escalation with DF9001 and nivolumab for Solid Tumors, Adult

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Rhode Island Hospital, Providence, RISolid Tumors, AdultDF9001 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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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.

Eligible Conditions
  • Solid Tumors, Adult

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
NEO-201 in combination with pembrolizumab
1
XL092
1
NGM831

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.

Week 4
Evaluate the immunogenicity of DF9001.
Week 4
Assessment of number of dose limiting toxicities experienced on study as defined per criteria in the study protocol
Day 7
Serum
Month 24
Assess progression-free survival (PFS) for DF9001 per an IERC.
Assess the duration of response (DOR) by IERC.
Week 6
Characterize the gene expression profile of DF9001 as a monotherapy.
Characterize the gene expression profile of DF9001 in combination with nivolumab.
Characterize the pharmacodynamic profile of DF9001 as a monotherapy.
Gene Expression Profiling
Day 28
Assess the safety and tolerability of DF9001 in combination with nivolumab.
Therapeutic procedure
Year 1
Assess Overall Response Rate
Assess the best overall response (BOR) by IERC.

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
NEO-201 in combination with pembrolizumab
1
XL092
1
NGM831

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

Combination Escalation with DF9001 and nivolumabExperimental Group · 2 Interventions: DF9001, Nivolumab · Intervention Types: Drug, Drug
Monotherapy DF9001 Expansion in Colorectal Cancer
Drug
Experimental Group · 1 Intervention: DF9001 · Intervention Types: Drug
Combination PK/PD Expansion with DF9001 and nivolumabExperimental Group · 2 Interventions: DF9001, Nivolumab · Intervention Types: Drug, Drug
Monotherapy DF9001 Expansion in Non-small Cell Lung Cancer
Drug
Experimental Group · 1 Intervention: DF9001 · Intervention Types: Drug
Combination Expansion of DF9001 and nivolumab in Head and Neck Squamous Cell CarcinomaExperimental Group · 2 Interventions: DF9001, Nivolumab · Intervention Types: Drug, Drug
Monotherapy DF9001 Expansion in Head and Neck Squamous Cell Carcinoma
Drug
Experimental Group · 1 Intervention: DF9001 · Intervention Types: Drug
Combination Expansion of DF9001 and nivolumab in Non-Small Cell Lung CancerExperimental Group · 2 Interventions: DF9001, Nivolumab · Intervention Types: Drug, Drug
Combination Expansion of DF9001 and nivolumab in Colorectal CancerExperimental Group · 2 Interventions: DF9001, Nivolumab · Intervention Types: Drug, Drug
Monotherapy DF9001 PK/PD Expansion
Drug
Experimental Group · 1 Intervention: DF9001 · Intervention Types: Drug
Monotherapy DF9001 Dose Escalation
Drug
Experimental Group · 1 Intervention: DF9001 · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4480

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months.

Who is running the clinical trial?

Dragonfly TherapeuticsLead Sponsor
2 Previous Clinical Trials
963 Total Patients Enrolled
1 Trials studying Solid Tumors, Adult
490 Patients Enrolled for Solid Tumors, Adult

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your blood counts are normal.
This is a trial to test different doses of a drug given alone or in combination with other drugs. You may be eligible if you meet certain requirements.
This is a requirement that applies to everyone who wants to participate in the study.
You have read and agreed to participate in the study by signing a document.
You are at least 18 years old, regardless of your gender.
You are healthy enough to perform daily activities on your own and are expected to live for at least 3 more months.
Your kidneys are working properly.
If you are a woman who could become pregnant, you must use a highly effective birth control method as defined by the World Health Organization, or use two effective methods at the same time.
You have a cancer that started in the lining of an organ and has spread to other parts of the body. Your tumor has a protein called EGFR, which can be detected by a laboratory test. You have already received standard treatment but your cancer has continued to grow.
Your liver is working properly.
References

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

Unverified Answer

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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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