Solid Tumor, AdultPhase 1NCT06108479
Study of DF6215 in Patients With Advanced Solid Tumors
A Phase 1 study testing DF6215, pembrolizumab and KEYTRUDA® in people with Solid Tumor, Adult and Solid Tumor Cancer, run by Dragonfly Therapeutics at 21 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult, Solid Tumor Cancer
- What is being tested?
- DF6215, pembrolizumab and KEYTRUDA®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 21 sitesin 3 countries
- Study dates
- 28 Nov 2023to 4 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Adequate renal function.
- Effective Contraception.
- Additional Inclusion Criteria apply to each cohort.
Who cannot join
- 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
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- 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 of systemic steroids (eg, for allergic reactions or the management of irAEs) and physiologic dose steroids (≤ 10 mg prednisone, or equivalent) for those with treated brain metastases are allowed. Patients receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug(s) will be excluded.
- Bisphosphonate or denosumab initiated within 14 days of the first dose of study drug(s)
- Previous malignant disease, other than the target malignancies to be investigated in this study, within the last 3 years. Exceptions (eg, basal or squamous cell carcinoma of the skin, low grade prostate cancer [Gleason score ≤ 6 and must be Stage I or II], or cervical carcinoma in situ) may be considered on a case-by-case basis, in consultation with the Medical Monitor.
- Any of the following cardiac abnormalities:
- A clinically relevant abnormality on the electrocardiogram (ECG)
- Clinically relevant coronary artery disease (CAD) or uncontrolled congestive heart failure
- Medically uncontrolled angina pectoris
- An implantable pacemaker or automatic implantable cardioverter-defibrillator
- A history of risk factors for ventricular tachycardia, torsades de pointes, fainting, unexplained loss of consciousness, or convulsions
- A history of heart failure, congestive heart failure, cardiomyopathy, uncontrolled hypokalemia, hypomagnesemia, or hypoglycemia; any evidence of conduction abnormality (eg, increased QRS complex)
- Congenital long QT syndrome or a prolonged QTc mean on screening ECG
- QTc > 470 msec for women and > 450 msec for men
- History of myocardial infarction within 6 months before the first dose of study drug(s)
- Received sotalol within 10 days of the first dose of study drug(s), or received a medication known to prolong the ECG QT interval within 14 days of the first dose of study drug(s)
- A heart rate of < 50 or > 100 bpm at rest on screening ECG
- Patients aged more than 50 years must have a normal cardiac stress test.
- Patients with history of CAD must have a normal stress test (eg, thallium or technetium-99m sestamibi) and be cleared to participate in the study.
- History of ocular/uveal melanoma or mucosal melanoma.
- Primary tumor site of nasopharynx (any histology).
- Patients with brain metastases are excluded, unless all of the following criteria are met:
- CNS lesions are asymptomatic and previously treated
- Patient does not require ongoing daily steroid treatment for replacement for adrenal insufficiency (except ≤ 10 mg prednisone [or equivalent]) for at least 14 days before the first dose of study drug
- Imaging demonstrates stable disease 28 days after last treatment
- Receipt of any organ transplant, including autologous or allogeneic stem-cell transplantation.
- Patients must not have received aldesleukin or any other experimental IL-2 based drug, including intralesional administration.
- Significant acute or chronic hepatitis B virus (HBV), hepatitis C virus (HCV) infection during the screening window, as well as historic positive for human immunodeficiency virus (HIV) or clinically significant active infections that render the patient ineligible for study treatment as determined by the treating investigator.
- Patients with known HIV infection are excluded unless they meet the following criteria:
- Must have CD4+ T-cell (CD4+) counts ≥ 350 cells/μL at the time of screening, and
- Must have no history of AIDS-related opportunistic infections of HIV-associated conditions such as Kaposi sarcoma or multicentric Castleman's disease, and
- Patients on antiretroviral therapy (ART) must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 or the LLOQ (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks before screening and agree to continue ART throughout the study
- Preexisting autoimmune disease (except vitiligo) needing treatment with systemic immunosuppressive agents for more than 28 days within the last 3 years, or clinically relevant immunodeficiencies (eg, dysgammaglobulinemia or congenital immunodeficiencies). Patients with a history of immune related endocrinopathies (eg, hypothyroidism, hyperthyroidism, and type 1 diabetes mellitus) that are stable on hormone replacement therapy are eligible for this study.
- Patients with a known medical history of keratitis, ulcerative keratitis, or corneal perforation.
- Patients with known history of neurologic conditions, cerebrovascular accident, or seizures.
- Known severe hypersensitivity reactions to mAbs (≥ Grade 3 as defined by NCI-CTCAE v5.0), any history of anaphylaxis, or uncontrolled asthma (ie, 3 or more features of partly controlled asthma).
- Persisting toxicity related to a prior therapeutic agent > Grade 1 as defined by NCI CTCAE v5.0 (however, ≤ Grade 2 alopecia, ≤ Grade 2 endocrinopathies, and ≤ Grade 2 sensory neuropathy are acceptable).
- Patients in certain cohorts with prior anti-PD-1 and anti-PD-L1 treatment are eligible for the study, unless they have experienced any of the following:
- Grade 3 or 4 treatment-related toxicity during an anti-PD-1 or anti-PD-L1 treatment (excluding Grade 3 or 4 immune-related endocrinopathies adequately controlled with hormone replacement therapy).
- Grade 2 treatment-related toxicity that impacted either the lungs, the nervous system, or the cardiac system, during an anti-PD-1 or anti-PD-L1 treatment (patients with a history of Grade 2 peripheral neuropathy, or paresthesia, not related to anti-PD-1 or anti-PD-L1 treatments are eligible).
- For combination basket cohorts: received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
- For combination basket cohorts: received any prior immunotherapy and was discontinued from that treatment due to a Grade 3 or higher irAE (except endocrine disorders that can be treated with replacement therapy) or was discontinued from that treatment due to Grade 2 myocarditis or recurrent Grade 2 pneumonitis.
- Known alcohol or drug abuse.
- Severe dyspnea at rest due to complications of advanced malignancy.
- Requiring supplementary oxygen therapy.
- All other significant diseases (eg, inflammatory bowel disease) which, in the opinion of the Investigator, might impair the patient's ability to participate.
- Legal incapacity or limited legal capacity.
- Unable to understand or give signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol. Examples include certain psychiatric conditions.
- Patients who have received a live or live-attenuated vaccine within 30 days before the first dose of study drug. Administration of killed vaccines is allowed.
- Pregnant or lactating.
- Severe hypersensitivity (≥ Grade 3) to study drugs and/or any of their excipients.
- Additional Exclusion Criteria apply to each cohort.
Trial locations and contacts
21 sites in 3 countries.
21 sites in 3 countries
France10 sites
Institut Bergonié
Bordeaux, 33000
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, 33075
Centre Georges François Leclerc
Dijon, 21000
CHU de Marseille - Hôpital de la Timone
Marseille, 13005
Institut Paoli-Calmettes
Marseille, 13009
Institut Curie
Paris, 75005
Hôpital Lyon-Sud
Pierre-Bénite, 69495
Centre Hospitalier Universitaire de Poitiers
Poitiers, 86000
Institut de Cancérologie de l'Ouest - Saint-Herblain - Site René Gauducheau
Saint-Herblain, 44805
Institut Universitaire du Cancer de Toulouse Oncopole
Toulouse, 31100
United States9 sites
The Angeles Clinic and Research Institute - West Los Angeles Office
Los Angeles, California, 90025
SCRI Oncology Partners
Nashville, Tennessee, 37203
NYU Langone Health
New York, New York, 10016
University of California Irvine Medical Center
Orange, California, 92868
Lifespan - Rhode Island Hospital
Providence, Rhode Island, 02903
University of California San Diego Moores Cancer Center
San Diego, California, 92093
Sarcoma Oncology Center
Santa Monica, California, 90403
Tampa General Hospital
Tampa, Florida, 33606
Moffitt Cancer Center
Tampa, Florida, 33612
Australia2 sites
Cancer Research SA (CRSA)
Adelaide, South Australia, 5000
Peninsula and South East Oncology Medical (PASO)
Frankston, Victoria, 3199
About this study
Official title: 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
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.
Read the detailed description
This Phase I/Ib trial involves multiple parts and includes both dose-escalation and dose-expansion phases. The primary objectives are to evaluate the safety and tolerability of DF6215, an investigational biologic agent, when administered either as a monotherapy or in combination with pembrolizumab, a known immunotherapy drug, and evaluate the clinical activity of DF6215 monotherapy and in combination with pembrolizumab. Secondary objectives include assessing pharmacokinetics, pharmacodynamics, and preliminary efficacy based on tumor response using RECIST 1.1 criteria. The trial will enroll adult patients with advanced (unresectable, recurrent, or metastatic) solid tumors, and the study design allows for dose modifications based on safety monitoring and the occurrence of dose-limiting toxicities (DLTs). The trial will also incorporate a safety monitoring committee to review data at regular intervals to ensure patient safety .
- Conditions
- Solid Tumor, Adult, Solid Tumor Cancer
- Being tested
- DF6215, pembrolizumab, KEYTRUDA®
- Keywords
- DF6215-001, DF6215, Melanoma, HPV-Positive Advanced Malignancies, Ovarian Cancer, Head and Neck Cancer, Non-Small Cell Lung Cancer, Renal Cell Carcinoma, Advanced or Metastatic Solid Tumors, Antineoplastic Agents, Antineoplastic Agents, Immunological, Molecular Mechanisms of Pharmacological Action, Neoplasms, Solid Tumor, Dose Escalation, oncology, pembrolizumab, KEYTRUDA®
- Medical subject headings
- Melanoma, Ovarian Neoplasms, Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DF6215Drug
Immunotherapy (cytokine) targeting effector cells.
pembrolizumabDrug
Anti-PD-1 immunotherapy agent
KEYTRUDA®Drug
Anti-PD-1 immunotherapy agent
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy Dose Escalation | Experimental | Patients will receive DF6215 monotherapy, with dose levels escalated to determine the MTD of DF6215 monotherapy. Receives: Drug: DF6215 |
| Combination Therapy Dose Escalation | Experimental | Patients will receive DF6215 in combination with pembrolizumab to determine the MTD of DF6215 in combination with pembrolizumab. Receives: Drug: DF6215; Drug: pembrolizumab; Drug: KEYTRUDA® |
| Monotherapy Dose Enrichment | Experimental | Patients with advanced melanoma after prior anti-PD-1 treatment will receive DF6215 monotherapy at two different dose levels to further characterize the doses selected during the Dose Escalation (monotherapy) part. Receives: Drug: DF6215 |
| Monotherapy Expansion of DF6215 in Advanced Melanoma | Experimental | Patients with advanced melanoma after prior anti-PD-1 will receive DF6215 monotherapy at the recommended efficacy expansion dose to evaluate the clinical activity of DF6215 in monotherapy. Receives: Drug: DF6215 |
| Combination Expansion of DF6215 and pembrolizumab in PROC | Experimental | Patients with platinum-resistant ovarian cancer (PROC) will receive DF6215 in combination with pembrolizumab at the recommended efficacy expansion dose to evaluate the clinical activity of DF6215 in combination with pembrolizumab. Receives: Drug: DF6215; Drug: pembrolizumab; Drug: KEYTRUDA® |
| Combination Expansion of DF6215 and pembrolizumab in Advanced Melanoma | Experimental | Patients with advanced melanoma after prior anti-PD-1 therapy will receive DF6215 in combination with pembrolizumab at the recommended combination efficacy expansion dose to evaluate the clinical activity of DF6215 in combination with pembrolizumab. Receives: Drug: DF6215; Drug: pembrolizumab; Drug: KEYTRUDA® |
| Monotherapy Expansion of DF6215 in Multiple Tumor Types (Basket) | Experimental | Patients with multiple tumor types will receive DF6215 monotherapy at the recommended efficacy expansion dose to evaluate the clinical activity of DF6215 in monotherapy. Receives: Drug: DF6215 |
| Combination Expansion of DF6215 and pembrolizumab in Multiple Tumor Types | Experimental | Patients with multiple tumor types will receive DF6215 in combination with pembrolizumab at the recommended combination efficacy expansion dose to evaluate the clinical activity of DF6215 in combination with pembrolizumab. Receives: Drug: DF6215; Drug: pembrolizumab; Drug: KEYTRUDA® |
| DF6215 Monotherapy Safety/PK/PD | Experimental | Expansion cohorts of DF6215 in multiple dose levels after evaluation for safety in the DF6215 Dose Escalation arm. Additional Pharmacokinetic (PK) and Pharmacodynamic (PD) samples included in this arm. Receives: Drug: DF6215 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of DF6215 Monotherapy and in Combination with Pembrolizumab
Determine the maximum tolerated dose of DF6215 both as monotherapy and when combined with pembrolizumab, by assessing the occurrence of dose-limiting toxicities.
Measured: First 28 days for monotherapy; first 42 days for combination therapy.
Safety and Tolerability of DF6215 Monotherapy and in Combination with Pembrolizumab
Evaluate the safety and tolerability of DF6215 monotherapy and in combination with pembrolizumab at various dose levels by monitoring the incidence, severity, and causality of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), and TEAEs leading to discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Measured: Continuously throughout the study, up to 2 years.
Efficacy Expansion: Clinical Activity of DF6215 monotherapy and in combination of Pembrolizumab
To evaluate the clinical activity of DF6215 monotherapy and in combination with pembrolizumab, measured by ORR per investigator assessment as defined by RECIST 1.1 in the efficacy expansion part.
Measured: Assessed from the start of treatment until disease progression or study end, up to 2 years.
Secondary outcomes (3)
Clinical Activity: Objective Response Rate (ORR), Disease Control Rate (DCR), and Clinical Benefit Rate (CBR)
Evaluate the clinical activity of DF6215 monotherapy and in combination with pembrolizumab, measured by ORR, DCR, and CBR as per RECIST 1.1.
Measured: Assessed every 8 weeks until disease progression or study termination, up to 2 years.
Pharmacokinetics (PK) Parameters
Assess the PK of DF6215 monotherapy and in combination with pembrolizumab at multiple dose levels, measured by PK parameters such as area under the concentration-time curve (AUC0-t), maximum concentration (Cmax), minimum concentration (Cmin), time to reach maximum concentration (tmax), and half-life (t½).
Measured: Samples collected at predetermined time points across the first and second cycles and periodically thereafter.
Immunogenicity: Incidence of Anti-Drug Antibodies (ADAs)
To assess the immunogenicity of DF6215 monotherapy and in combination with pembrolizumab, measured by incidence of patients with anti-drug antibodies against DF6215.
Measured: Samples collected at predetermined time points across the first and second cycles and periodically thereafter.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start28 Nov 2023
- Primary completion4 Dec 2025
- Study completion4 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dragonfly Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06108479
- Sponsor's protocol ID
- DF6215-001
- Other IDs
- KEYNOTE-G13, MK-3475-G13
- Status last verified
- Mar 2026
- First submitted
- 25 Oct 2023
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06108479
- Acronym / sponsor ID
- DF6215-001
- Conditions
- Solid Tumor, Adult, Solid Tumor Cancer
- Keywords
- DF6215-001, DF6215, Melanoma, HPV-Positive Advanced Malignancies, Ovarian Cancer, Head and Neck Cancer, Non-Small Cell Lung Cancer, Renal Cell Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Dragonfly TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- 4 Dec 2025 (actual)
- Study completion
- 4 Dec 2025 (actual)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This Phase I/Ib trial involves multiple parts and includes both dose-escalation and dose-expansion phases. The primary objectives are to evaluate the safety and tolerability of DF6215, an investigational biologic agent, when administered either as a monotherapy or in combination with pembrolizumab, a known immunotherapy drug, and evaluate the clinical activity of DF6215 monotherapy and in combination with pembrolizumab. Secondary objectives include assessing pharmacokinetics, pharmacodynamics, and preliminary efficacy based on tumor response using RECIST 1.1 criteria. The trial will enroll adult patients with advanced (unresectable, recurrent, or metastatic) solid tumors, and the study design allows for dose modifications based on safety monitoring and the occurrence of dose-limiting toxicities (DLTs). The trial will also incorporate a safety monitoring committee to review data at regular intervals to ensure patient safety .
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Monotherapy Dose Escalation | Experimental | Drug: DF6215Patients will receive DF6215 monotherapy, with dose levels escalated to determine the MTD of DF6215 monotherapy. |
| Combination Therapy Dose Escalation | Experimental | Drug: DF6215, Drug: pembrolizumab, Drug: KEYTRUDA®Patients will receive DF6215 in combination with pembrolizumab to determine the MTD of DF6215 in combination with pembrolizumab. |
| Monotherapy Dose Enrichment | Experimental | Drug: DF6215Patients with advanced melanoma after prior anti-PD-1 treatment will receive DF6215 monotherapy at two different dose levels to further characterize the doses selected during the Dose Escalation (monotherapy) part. |
| Monotherapy Expansion of DF6215 in Advanced Melanoma | Experimental | Drug: DF6215Patients with advanced melanoma after prior anti-PD-1 will receive DF6215 monotherapy at the recommended efficacy expansion dose to evaluate the clinical activity of DF6215 in monotherapy. |
| Combination Expansion of DF6215 and pembrolizumab in PROC | Experimental | Drug: DF6215, Drug: pembrolizumab, Drug: KEYTRUDA®Patients with platinum-resistant ovarian cancer (PROC) will receive DF6215 in combination with pembrolizumab at the recommended efficacy expansion dose to evaluate the clinical activity of DF6215 in combination with pembrolizumab. |
| Combination Expansion of DF6215 and pembrolizumab in Advanced Melanoma | Experimental | Drug: DF6215, Drug: pembrolizumab, Drug: KEYTRUDA®Patients with advanced melanoma after prior anti-PD-1 therapy will receive DF6215 in combination with pembrolizumab at the recommended combination efficacy expansion dose to evaluate the clinical activity of DF6215 in combination with pembrolizumab. |
| Monotherapy Expansion of DF6215 in Multiple Tumor Types (Basket) | Experimental | Drug: DF6215Patients with multiple tumor types will receive DF6215 monotherapy at the recommended efficacy expansion dose to evaluate the clinical activity of DF6215 in monotherapy. |
| Combination Expansion of DF6215 and pembrolizumab in Multiple Tumor Types | Experimental | Drug: DF6215, Drug: pembrolizumab, Drug: KEYTRUDA®Patients with multiple tumor types will receive DF6215 in combination with pembrolizumab at the recommended combination efficacy expansion dose to evaluate the clinical activity of DF6215 in combination with pembrolizumab. |
| DF6215 Monotherapy Safety/PK/PD | Experimental | Drug: DF6215Expansion cohorts of DF6215 in multiple dose levels after evaluation for safety in the DF6215 Dose Escalation arm. Additional Pharmacokinetic (PK) and Pharmacodynamic (PD) samples included in this arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (59 listed)
- 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:
- Previous malignant disease, other than the target malignancies to be investigated in this study, within the last 3 years. Exceptions (eg, basal or squamous cell carcinoma of the skin, low grade prostate cancer [Gleason score ≤ 6 and must be Stage I or II], or cervical carcinoma in situ) may be considered on a case-by-case basis, in consultation with the Medical Monitor.
- Any of the following cardiac abnormalities:
- Patients aged more than 50 years must have a normal cardiac stress test.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DF6215Immunotherapy (cytokine) targeting effector cells. | Drug | Combination Expansion of DF6215 and pembrolizumab in Advanced Melanoma, Combination Expansion of DF6215 and pembrolizumab in Multiple Tumor Types, Combination Expansion of DF6215 and pembrolizumab in PROC, Combination Therapy Dose Escalation, DF6215 Monotherapy Safety/PK/PD, Monotherapy Dose Enrichment, Monotherapy Dose Escalation, Monotherapy Expansion of DF6215 in Advanced Melanoma, Monotherapy Expansion of DF6215 in Multiple Tumor Types (Basket) |
| pembrolizumabAnti-PD-1 immunotherapy agent | Drug | Combination Expansion of DF6215 and pembrolizumab in Advanced Melanoma, Combination Expansion of DF6215 and pembrolizumab in Multiple Tumor Types, Combination Expansion of DF6215 and pembrolizumab in PROC, Combination Therapy Dose Escalation |
| KEYTRUDA®Anti-PD-1 immunotherapy agent | Drug | Combination Expansion of DF6215 and pembrolizumab in Advanced Melanoma, Combination Expansion of DF6215 and pembrolizumab in Multiple Tumor Types, Combination Expansion of DF6215 and pembrolizumab in PROC, Combination Therapy Dose Escalation |
Primary outcome
Maximum Tolerated Dose (MTD) of DF6215 Monotherapy and in Combination with Pembrolizumab
Time frame: First 28 days for monotherapy; first 42 days for combination therapy.
Determine the maximum tolerated dose of DF6215 both as monotherapy and when combined with pembrolizumab, by assessing the occurrence of dose-limiting toxicities.
Safety and Tolerability of DF6215 Monotherapy and in Combination with Pembrolizumab
Time frame: Continuously throughout the study, up to 2 years.
Evaluate the safety and tolerability of DF6215 monotherapy and in combination with pembrolizumab at various dose levels by monitoring the incidence, severity, and causality of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), and TEAEs leading to discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Efficacy Expansion: Clinical Activity of DF6215 monotherapy and in combination of Pembrolizumab
Time frame: Assessed from the start of treatment until disease progression or study end, up to 2 years.
To evaluate the clinical activity of DF6215 monotherapy and in combination with pembrolizumab, measured by ORR per investigator assessment as defined by RECIST 1.1 in the efficacy expansion part.
3 secondary outcomes
Clinical Activity: Objective Response Rate (ORR), Disease Control Rate (DCR), and Clinical Benefit Rate (CBR)
Time frame: Assessed every 8 weeks until disease progression or study termination, up to 2 years.
Pharmacokinetics (PK) Parameters
Time frame: Samples collected at predetermined time points across the first and second cycles and periodically thereafter.
Immunogenicity: Incidence of Anti-Drug Antibodies (ADAs)
Time frame: Samples collected at predetermined time points across the first and second cycles and periodically thereafter.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DF6215, pembrolizumab and KEYTRUDA® in people with Solid Tumor, Adult and Solid Tumor Cancer, run by Dragonfly Therapeutics at 21 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 59 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in France, United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) of DF6215 Monotherapy and in Combination with Pembrolizumab (time frame: First 28 days for monotherapy; first 42 days for combination therapy.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.