This trial is studying a new molecule, DF1001, that targets the activation signals of natural killer (NK) cells and T-cells to receptors on cancer cells. The trial will occur in two phases, with the first phase testing different doses of DF1001 on patients with various types of solid tumors to see what is the best dose. The second phase will use the best dose from the first phase on patients with either selected solid tumors, or solid tumors expressing high levels of HER2.

Eligible Conditions

Solid Tumors, Adult

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1

ORIC-101

1

ON123300

1

BP1001-A (Liposomal Grb2 Antisense Oligonucleotide) with paclitaxel

Study Objectives

4 Primary · 14 Secondary · Reporting Duration: From time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months

Week 3

Evaluation of DF1001 Immunogenicity

Evaluation of DF1001 immunogenicity

Week 3

Assessment of number of dose limiting toxicities experienced on study as defined per criteria in the study protocol

Day 28

Evaluation of DF1001 Pharmacokinetics

Serum concentrations of DF1001 will be determined at various time points

Month 24

Assess DOR by Investigator Assessment.

Assess Duration of Response

Assess ORR by Investigator Assessment.

Assess PFS by Investigator Assessment.

Assess Progression Free Survival (PFS)

Day 28

Assess number of adverse events observed during treatment with DF1001 in combination with Nab paclitaxel

Assess number of adverse events observed during treatment with DF1001 in combination with Nivolumab

Assess number of adverse events observed during treatment with DF1001 in combination with nivolumab

Year 1

Assess BOR by Investigator Assessment.

Assess Best Overall Response

Assess Overall Response Rate

Year 2

Assess Overall Survival (OS) Time.

Assess Overall Survival (OS) time.

Trial Safety

Safety Progress

1 of 3

Similar Trials

1

ORIC-101

1

ON123300

1

BP1001-A (Liposomal Grb2 Antisense Oligonucleotide) with paclitaxel

Trial Design

22 Treatment Groups

Combination Therapy with DF1001 and Nivolumab Expansion in Gastric Cancer

1 of 22

Combination Therapy with DF1001 and Nivolumab Expansion in Esophageal Cancer

1 of 22

Monotherapy DF1001 Expansion in Esophageal Cancer

1 of 22

Combination Therapy with DF1001 and Nivolumab Expansion in NSCLC

1 of 22

Monotherapy DF1001 Expansion in Cancers with Erbb2 Amplification

1 of 22

Monotherapy DF1001 Safety/PK/PD Expansion

1 of 22

Monotherapy DF1001 Expansion in Metastatic Breast Cancer (HER2 Low)

1 of 22

Combination Therapy with DF1001 and Nab-paclitaxel

1 of 22

Monotherapy DF1001 Expansion in Gastric Cancer

1 of 22

Monotherapy DF1001 Expansion in NSCLC

1 of 22

Combination Therapy with DF1001 and Nivolumab

1 of 22

Combination Therapy with DF1001 and Nivolumab Safety/PK/PD Expansion

1 of 22

Combination Therapy with DF1001 and Nab-paclitaxel Safety/PK/PD Expansion

1 of 22

Combination Therapy with DF1001 and Nivolumab Expansion in Urothelial Bladder Ca...

1 of 22

Monotherapy DF1001 Expansion in Metastatic Breast Cancer (HER2 High)

1 of 22

Monotherapy DF1001 Dose Escalation

1 of 22

Monotherapy DF1001 PK/PD Expansion

1 of 22

Combination Therapy with DF1001 and Nab paclitaxel

1 of 22

Monotherapy DF1001 Expansion in HER-2 High Expressing Cancers

1 of 22

Combination Therapy with DF1001 and nivolumab

1 of 22

Monotherapy DF1001 Expansion in Metastatic Breast Cancer

1 of 22

Monotherapy DF1001 Expansion in Urothelial Bladder Cancer

1 of 22

Experimental Treatment

490 Total Participants · 22 Treatment Groups

Primary Treatment: DF1001 · No Placebo Group · Phase 1 & 2

Combination Therapy with DF1001 and Nivolumab Expansion in Gastric CancerExperimental Group · 2 Interventions: DF1001, Nivolumab · Intervention Types: Drug, Drug

Combination Therapy with DF1001 and Nivolumab Expansion in Esophageal CancerExperimental Group · 2 Interventions: DF1001, Nivolumab · Intervention Types: Drug, Drug

Monotherapy DF1001 Expansion in Esophageal Cancer

Drug

Experimental Group · 1 Intervention: DF1001 · Intervention Types: Drug

Combination Therapy with DF1001 and Nivolumab Expansion in NSCLCExperimental Group · 2 Interventions: DF1001, Nivolumab · Intervention Types: Drug, Drug

Monotherapy DF1001 Expansion in Cancers with Erbb2 Amplification

Drug

Experimental Group · 1 Intervention: DF1001 · Intervention Types: Drug

Monotherapy DF1001 Safety/PK/PD Expansion

Drug

Experimental Group · 1 Intervention: DF1001 · Intervention Types: Drug

Monotherapy DF1001 Expansion in Metastatic Breast Cancer (HER2 Low)

Drug

Experimental Group · 1 Intervention: DF1001 · Intervention Types: Drug

Combination Therapy with DF1001 and Nab-paclitaxelExperimental Group · 2 Interventions: DF1001, Nab paclitaxel · Intervention Types: Drug, Drug

Monotherapy DF1001 Expansion in Gastric Cancer

Drug

Experimental Group · 1 Intervention: DF1001 · Intervention Types: Drug

Monotherapy DF1001 Expansion in NSCLC

Drug

Experimental Group · 1 Intervention: DF1001 · Intervention Types: Drug

Combination Therapy with DF1001 and NivolumabExperimental Group · 2 Interventions: DF1001, Nivolumab · Intervention Types: Drug, Drug

Combination Therapy with DF1001 and Nivolumab Safety/PK/PD ExpansionExperimental Group · 2 Interventions: DF1001, Nivolumab · Intervention Types: Drug, Drug

Combination Therapy with DF1001 and Nab-paclitaxel Safety/PK/PD ExpansionExperimental Group · 2 Interventions: DF1001, Nab paclitaxel · Intervention Types: Drug, Drug

Combination Therapy with DF1001 and Nivolumab Expansion in Urothelial Bladder CancerExperimental Group · 2 Interventions: DF1001, Nivolumab · Intervention Types: Drug, Drug

Monotherapy DF1001 Expansion in Metastatic Breast Cancer (HER2 High)

Drug

Experimental Group · 1 Intervention: DF1001 · Intervention Types: Drug

Monotherapy DF1001 Dose Escalation

Drug

Experimental Group · 1 Intervention: DF1001 · Intervention Types: Drug

Monotherapy DF1001 PK/PD Expansion

Drug

Experimental Group · 1 Intervention: DF1001 · Intervention Types: Drug

Combination Therapy with DF1001 and Nab paclitaxelExperimental Group · 2 Interventions: DF1001, Nab paclitaxel · Intervention Types: Drug, Drug

Monotherapy DF1001 Expansion in HER-2 High Expressing Cancers

Drug

Experimental Group · 1 Intervention: DF1001 · Intervention Types: Drug

Combination Therapy with DF1001 and nivolumabExperimental Group · 2 Interventions: DF1001, Nivolumab · Intervention Types: Drug, Drug

Monotherapy DF1001 Expansion in Metastatic Breast Cancer

Drug

Experimental Group · 1 Intervention: DF1001 · Intervention Types: Drug

Monotherapy DF1001 Expansion in Urothelial Bladder Cancer

Drug

Experimental Group · 1 Intervention: DF1001 · Intervention Types: Drug

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

FDA approved

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

835 Total Patients Enrolled

1 Trials studying Solid Tumors, Adult

362 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:

You are male or female and aged ≥ 18 years.

You have adequate renal function.

About The Reviewer

Michael Gill - B. Sc.

First Published: October 29th, 2021

Last Reviewed: November 23rd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References

2019. "Study of DF1001 in Patients With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04143711.

DF1001 for Solid Tumors, Adult

Study Summary

Treatment Effectiveness

Effectiveness Progress

Similar Trials

Study Objectives

Trial Safety

Safety Progress

Similar Trials

Trial Design

22 Treatment Groups

Combination Therapy with DF1001 and Nivolumab Expansion in Gastric Cancer

1 of 22

Combination Therapy with DF1001 and Nivolumab Expansion in Esophageal Cancer

1 of 22

Monotherapy DF1001 Expansion in Esophageal Cancer

1 of 22

Combination Therapy with DF1001 and Nivolumab Expansion in NSCLC

1 of 22

Monotherapy DF1001 Expansion in Cancers with Erbb2 Amplification

1 of 22

Monotherapy DF1001 Safety/PK/PD Expansion

1 of 22

Monotherapy DF1001 Expansion in Metastatic Breast Cancer (HER2 Low)

1 of 22

Combination Therapy with DF1001 and Nab-paclitaxel

1 of 22

Monotherapy DF1001 Expansion in Gastric Cancer

1 of 22

Monotherapy DF1001 Expansion in NSCLC

1 of 22

Combination Therapy with DF1001 and Nivolumab

1 of 22

Combination Therapy with DF1001 and Nivolumab Safety/PK/PD Expansion

1 of 22

Combination Therapy with DF1001 and Nab-paclitaxel Safety/PK/PD Expansion

1 of 22

Combination Therapy with DF1001 and Nivolumab Expansion in Urothelial Bladder Ca...

1 of 22

Monotherapy DF1001 Expansion in Metastatic Breast Cancer (HER2 High)

1 of 22

Monotherapy DF1001 Dose Escalation

1 of 22

Monotherapy DF1001 PK/PD Expansion

1 of 22

Combination Therapy with DF1001 and Nab paclitaxel

1 of 22

Monotherapy DF1001 Expansion in HER-2 High Expressing Cancers

1 of 22

Combination Therapy with DF1001 and nivolumab

1 of 22

Monotherapy DF1001 Expansion in Metastatic Breast Cancer

1 of 22

Monotherapy DF1001 Expansion in Urothelial Bladder Cancer

1 of 22

Trial Logistics

Trial Timeline

Who is running the clinical trial?

Eligibility Criteria

About The Reviewer

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