Neoplasms
Conditions
Brief summary
This is an open-label, multicenter, Phase I study to evaluate the safety, tolerability, and PK of escalating doses of DLYE5953A administered to patients with incurable, locally advanced, or metastatic solid malignancy that has progressed on standard therapy. The Phase I study consists of two stages: Stage 1 dose-escalation and Stage 2 expansion in selected patients. In Stage 1, a 3 + 3 dose-escalation design will be used to examine the safety, tolerability, and PK of increasing doses of DLYE5953A. In Stage 2, patients will be enrolled to further characterize the safety, tolerability, and PK of the proposed dose and schedule for future studies.
Interventions
DRUGDLYE5953A
Escalating doses of DLYE5953A
Sponsors
Genentech, Inc.
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>/= 18 years * ECOG performance status of 0 or 1 * Histologically or cytologically documented advanced or metastatic solid tumors for which established therapy either does not exist or has proven ineffective or intolerable * Measurable disease by RECIST v1.1 with at least one measurable target lesion
Exclusion criteria
* Treatment with chemotherapy, hormonal therapy (except hormone replacement therapy, oral contraceptives), immunotherapy, biologic therapy, radiation therapy (except palliative radiation to bony metastases), or herbal therapy as cancer therapy within 4 weeks prior to initiation of DLYE5953A * Oral kinase inhibitors approved by local regulatory authorities may be used within 2 weeks prior to initiation of DLYE5953A, provided that any clinically relevant drug-related toxicity has completely resolved and prior approval is obtained from the Medical Monitor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of dose-limiting toxicities | Days 1 to 21 |
| Incidence of adverse events | Up to 32 months |
Secondary
| Measure | Time frame |
|---|---|
| Objective response according to Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1 | Up to 32 months |
| Total exposure of the drug, defined as the area under the concentration-time curve (AUC) | Up to 32 months |
| Progression-free survival | Up to 32 months |
| Duration of objective response | Up to 32 months |
| Incidence of anti-DLYE5953A antibodies | Up to 32 months |
Countries
United States
Outcome results
None listed