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Dose Escalation of DF1001 in Patients With Advanced Solid Tumors, and Expansion in Selected Indications
EU CTIS ID: 2023-503291-24-00
What this study is testing
Dose Escalation Part: - To assess the safety and tolerability of DF1001 monotherapy, and to determine the Maximum Tolerated Dose (MTD) of DF1001 in patients with advanced (unresectable, recurrent, or metastatic) solid tumors. - To assess the safety and tolerability of DF1001 monotherapy, DF1001 with nivolumab and DF1001 with nab-paclitaxel combination therapies. Exploratory Efficacy Part: - To assess key safety and tolerability of DF1001 monotherapy and DF1001 combination therapy with sacituzumab govitecan-hziy. - To evaluate the confirmed objective response rate (ORR) of DF1001 monotherapy and DF1001 combination therapy with sacituzumab govitecanhziy. Efficacy Expansion Cohorts Part: - To assess the confirmed ORR according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) per Investigator assessment.
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed written informed consent.
- Male or female patients aged ≥ 18 years.
- ECOG performance status of 0 to 1 at study entry.
- Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1. (Not applicable to "Accelerated Titration and 3+3 Dose Escalation" cohorts.
- Baseline LVEF ≥ 55% measured by echocardiography (preferred) or MUGA scan.
- Adequate hematological function defined by white blood cell (WBC) count ≥ 3 × 109/L with absolute neutrophil count (ANC) ≥ 1.5 × 109/L, lymphocyte count ≥ 0.5 × 109/L, platelet count ≥ 75 × 109/L (in Dose Escalation, Safety/PK/PD, and Dose Expansion parts), platelet count ≥ 100 × 109/L (in Efficacy Expansion part), and hemoglobin ≥ 9 g/dL (may have been transfused but must show hematologic count stability for 14 days from the time of transfusion to C1D1).
You likely can't join if
- Previous treatment with drugs that specifically target the HER2 pathway (mAb or Tyrosine Kinase Inhibitor [TKI]) is acceptable providing washout period
- Concurrent anticancer treatment, immune therapy, or cytokine therapy
- Life expectancy of less than 3 months.
- Active or history of central nervous system (CNS) metastases.
- Receipt of any organ transplantation including autologous or allogeneic stem-cell transplantation.
- Significant acute or chronic infections
See the full eligibility criteria
- Signed written informed consent.
- Male or female patients aged ≥ 18 years.
- ECOG performance status of 0 to 1 at study entry.
- Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1. (Not applicable to "Accelerated Titration and 3+3 Dose Escalation" cohorts.
- Baseline LVEF ≥ 55% measured by echocardiography (preferred) or MUGA scan.
- Adequate hematological function defined by white blood cell (WBC) count ≥ 3 × 109/L with absolute neutrophil count (ANC) ≥ 1.5 × 109/L, lymphocyte count ≥ 0.5 × 109/L, platelet count ≥ 75 × 109/L (in Dose Escalation, Safety/PK/PD, and Dose Expansion parts), platelet count ≥ 100 × 109/L (in Efficacy Expansion part), and hemoglobin ≥ 9 g/dL (may have been transfused but must show hematologic count stability for 14 days from the time of transfusion to C1D1).
- Adequate hepatic function defined by a total bilirubin level ≤ 1.5 × the upper limit of normal (ULN). Aspartate aminotransferase (AST) level ≤ 2.5 × ULN, and an alanine aminotransferase (ALT) level ≤ 2.5 × ULN or, for patients with documented metastatic disease to the liver, AST and ALT levels ≤ 5 × ULN. Patients with known Gilbert Disease who have serum bilirubin level ≤ 3 ULN may be enrolled.
- Adequate renal function defined by an estimated creatinine clearance ≥ 50 mL/min according to the Cockcroft-Gault formula or another calculation of measurement method as according to local standards.
- Subjects must be willing to use appropriate contraception as defined in the protocol. Effective contraception for women of childbearing potential (WOCBP) and male patients as defined by World Health Organization (WHO) guidelines for 1 "highly effective" method or 2 "effective" methods. CTFG. WOCBP require use of a highly effective contraceptive measure. Contraception methods with low user dependency should preferably be 1used, in particular when contraception is introduced as a result of participation in the clinical trial for 120 days after last dose. A male subject should use condom during treatment and until the end of relevant systemic exposure in the male subject plus a further 90-day period. For a non-pregnant WOCBP partner, contraception recommendations should also be considered
- Previous treatment with drugs that specifically target the HER2 pathway (mAb or Tyrosine Kinase Inhibitor [TKI]) is acceptable providing washout period
- Concurrent anticancer treatment, immune therapy, or cytokine therapy
- Life expectancy of less than 3 months.
- Active or history of central nervous system (CNS) metastases.
- Receipt of any organ transplantation including autologous or allogeneic stem-cell transplantation.
- Significant acute or chronic infections
- Preexisting autoimmune disease (except for patients with vitiligo) needing treatment with systemic immunosuppressive agents ≥ 28 days within the last 3 years or clinically relevant immunodeficiencies (e.g, dys-gammaglobulinemia or congenital immunodeficiencies), or fever Grade 2 or higher within 7 days of Day 1. Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study. Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible for this study.
- Pregnancy or lactation in females during the study.
- Serious cardiac illness or clinically relevant uncontrolled cardiac risk factors
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.