A Phase Ib, open label, multicenter study of the safety and efficacy of MIW815 (ADU-S100) administered by intratumoral injection with PDR001 to patients with advanced/metastatic solid tumors or lymphomas
- Conditions
- Solid tumors and lymphoma (lymph tissue cancer)10027655
- Registration Number
- NL-OMON48864
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
1. Male and female *18 years of age.
2. Measurable disease as determined by RECIST v1.1 (for solid tumors) or Cheson
2014 criteria (for lymphoma).
3. At least two sites of disease amenable to biopsy, and willing to undergo new
tumor biopsy at screening and during therapy. See protocol page 30-31 for
details.
4. Dose escalation part: Advanced/metastatic solid tumors or lymphomas that
have progressed despite standard therapy or where standard therapy is not
tolerated, for whom no standard therapy exists or for whom standard therapy is
not reasonably effective.
5. Dose expansion part: Melanoma patients with accessible cutaneous or
subcutaneous lesions, who have relapsed or progressed after responding to a
PD-1 inhibitor or who are refractory to PD-1 Inhibitors, HNSCC or patients with
other accessible cutaneous or subcutaneous solid tumors and lymphomas, that
have progressed despite standard therapy or are intolerant of standard therapy,
for whom no standard therapy exists or for whom standard therapy is not
reasonably effective. In addition, patients with injectable visceral lesions
who have MSS CRC or other solid tumors with accessible visceral lesions, who
have progressed despite standard therapy or are intolerant of standard therapy,
for whom no standard therapy exists or for whom standard therapy is not
reasonably effective.
6. ECOG performance status 0-1
1. Patients who require immediate local palliative measures such as XRT or
surgery.
2. Symptomatic or untreated leptomeningeal disease.
3. Symptomatic -CNS metastases, see protocol page 31 for details.
4. Laboratory abnormalities:
- Creatinine > 1.5 x upper limit of normal (ULN)
- Total bilirubin > 1.5 x ULN (except for Gilbert*s syndrome > 3.0 x ULN)
- ALT and AST (liver) > 3 x ULN (except when livermetastasis > 5 x ULN_
- Absolute neutrophil count < 1.0 x 109/L
- Platelet count < 75 x 109/L, except for patients in Group C: platelet count <
100 x 109/L
- INR > 1.5 x ULN and/or aPTT > 1.5 x ULN, except for patients in Group C: INR
and aPTT must be normal
- Hemoglobin (Hgb) < 9 g/dL (5,59 mmol/l)
- Potassium, magnesium, calcium or phosphate > grade 1 using CTCAE v4.03
5. Impaired cardiac function or clinically significant cardiac disease, see
protocol page 42 for details.
6. Active, known or suspected autoimmune disease or a documented history of
autoimmune disease, see protocol page 43 for details.
7. Active infection requiring systemic antibiotic therapy.
8. Cytotoxic or targeted antineoplastics within 14 days prior to the first dose
of study treatment, see protocol page 43 for details.
9. Systemic chronic steroid therapy (* 10mg/day prednisone or equivalent) or
any immunosuppressive therapy 7 days prior to start of study treatment.
10. Use of any live vaccines against infectious diseases within 4 weeks of
initiation of study treatment.
11. Use of G-CSF and comparable, see protocol page 43/44 for details.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Iincidence and severity of (serious) adverse events, including changs in<br /><br>laboratory parameters, vital signs, ECGs, incidence of DLT during the 1st<br /><br>cycle.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Overall response rate, progression free survival, duration of response, disease<br /><br>control rate, PK parameters. Antidrug antibodies. Tumor Infiltrating<br /><br>lymphocytes in (non-)injected lesions.</p><br>