Study of DF6215 in Patients With Advanced Solid Tumors (NCT06108479) | Clinical Trial Compass
CompletedPhase 1
Study of DF6215 in Patients With Advanced Solid Tumors
United States, Australia, France35 participantsStarted 2023-11-28
Plain-language summary
A Phase I/Ib, First-In-Human, Multi-Part, Open-Label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of DF6215 Monotherapy and in Combination Therapy in Patients with Advanced (Unresectable, Recurrent, or Metastatic) Solid Tumors; is designed to assess the safety, tolerability, and preliminary efficacy of DF6215 alone or in combination with pembrolizumab in patients with advanced solid tumors. The study is open-label, meaning both participants and investigators are aware of the treatment being administered.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria
* Male or female patients ≥ 18 years old.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* An estimated life expectancy of ≥ 3 months.
* Adequate hematological function.
* Normal pulmonary function.
* Adequate hepatic function.
* Adequate renal function.
* Effective Contraception.
* Additional Inclusion Criteria apply to each cohort.
Key Exclusion Criteria
* Patients receiving chemotherapy, radiotherapy (other than palliative bone-directed radiotherapy), major surgery, or receiving another systemic anticancer therapeutic agent within 28 days before the start of study drug(s) or within 5 half-lives of the previous therapeutic agent (if known), whichever is shorter.
* Patients receiving any of the following concurrent anticancer treatments or investigational drugs within 28 days before the start of the study drug(s), or within 5 half-lives of the previous therapeutic agent (if known), whichever is shorter:
* Cytoreductive therapy
* Radiotherapy (except for palliative bone-directed radiotherapy)
* Note: ≤ 2 weeks of palliative radiotherapy for non-CNS disease is permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study drug.
* Immune therapy
* Cytokine therapy (except for erythropoietin)
* Major surgery (excluding prior diagnostic biopsy)
* Concurrent systemic therapy with steroids or other immunosuppressive agents.
* Note that short-term administration …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum Tolerated Dose (MTD) of DF6215 Monotherapy and in Combination with Pembrolizumab
Timeframe: First 28 days for monotherapy; first 42 days for combination therapy.
2
Safety and Tolerability of DF6215 Monotherapy and in Combination with Pembrolizumab
Timeframe: Continuously throughout the study, up to 2 years.
3
Efficacy Expansion: Clinical Activity of DF6215 monotherapy and in combination of Pembrolizumab
Timeframe: Assessed from the start of treatment until disease progression or study end, up to 2 years.