Dose Escalation of DF1001 in Patients With Advanced Solid Tumors, and Expansion in Selected Indications

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 358

Inclusion Criteria

Common Inclusion Criteria For All Groups/Cohorts/Combinations:
- 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
used, 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 318
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

Exclusion Criteria for All Patients of Both Study Parts:
1. Previous treatment with drugs that specifically target the HER2 pathway (mAb or Tyrosine Kinase Inhibitor [TKI]) is acceptable providing washout period
2. Concurrent anticancer treatment, immune therapy, or cytokine therapy
3. Life expectancy of less than 3 months.
4. Active or history of central nervous system (CNS) metastases.
5. Receipt of any organ transplantation including autologous or allogeneic stem-cell transplantation.
6. Significant acute or chronic infections
7. Preexisting autoimmune disease 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.
8. Pregnancy or lactation in females during the study.
9. Serious cardiac illness or clinically relevant uncontrolled cardiac risk factors

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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