A Study Evaluating the Safety of Escalating Doses of DLYE5953A in Patients With Refractory Solid Tumors

Study Overview
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Brief Summary
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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.

Official Title
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A PHASE I, OPEN-LABEL STUDY EVALUATING THE SAFETY AND TOLERABILITY OF ESCALATING DOSES OF DLYE5953A IN PATIENTS WITH REFRACTORY SOLID TUMORS

Conditions
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Neoplasms

Intervention / Treatment
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* Drug: DLYE5953A
* Drug: DLYE5953A


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose-Escalation Phase<br> | Drug: DLYE5953A<br>* Escalating doses of DLYE5953A<br>|
| Experimental: Dose-expansion cohort<br> | Drug: DLYE5953A<br>* Administration of DLYE5953A at the recommended phase II dose (RP2D)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of dose-limiting toxicities |  | Days 1 to 21 | 
| Incidence of adverse events |  | Up to 32 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total exposure of the drug, defined as the area under the concentration-time curve (AUC) |  | Up to 32 months | 
| Incidence of anti-DLYE5953A antibodies |  | Up to 32 months | 
| Objective response according to Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1 |  | Up to 32 months | 
| Duration of objective response |  | Up to 32 months | 
| Progression-free survival |  | Up to 32 months |