PRO1160 for Advanced Solid and Liquid Tumors (PRO1160-001)

Study Overview
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Brief Summary
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Brief Summary: This study will test the safety, including side effects, and determine the characteristics of a drug called PRO1160 in participants with solid tumors. Participants will have solid tumor or liquid cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable). This Phase 1/2 study will have two parts. Part A of the study will find out how much and how frequently PRO1160 should be given to participants. Part B will use the dose and schedule found in Part A to find out how safe PRO1160 is and if it works to treat the diseases under study. The diseases under study will be Renal Cell Carcinoma (RCC),Nasopharyngeal Carcinoma (NPC) and Non-Hodgkin Lymphoma (NHL).

Detailed Description
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This is a Phase 1/2 study of PRO1160, a CD70 targeted antibody-drug conjugate, to evaluate the safety, tolerability, PK, and antitumor activity of PRO1160 in patients with selected locally advanced /or metastatic solid and liquid tumors, including renal cell carcinoma, nasopharyngeal carcinoma and non-hodgkin lymphoma. This study consists of 2 parts, Part A: Dose Escalation and Part B: Dose Expansion. Part A may evaluate up to 7 dose levels of PRO1160 on Day 1 of a 21 day cycle by IV infusion. Part B will be initiated at a dose level based on a comprehensive analysis of safety, tolerability, clinical PK, PD and activity data from Part A in up to 4 different cohorts of up to 20 patients per cohort. Patients will continue to receive study treatment until the first instance of disease progression, unacceptable toxicity, investigator decision, consent withdrawal, study termination by the Sponsor, pregnancy, or death.

Official Title
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Phase 1/2 Study of PRO1160 in Patients With Renal Cell Carcinoma (RCC), Nasopharyngeal Carcinoma (NPC), or Non-Hodgkin Lymphoma (NHL)

Conditions
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Renal Cell Carcinoma, Nasopharyngeal Carcinoma, Non Hodgkin Lymphoma

Intervention / Treatment
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* Drug: PRO1160


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically confirmed metastatic or unresectable solid malignancy including Renal Cell carcinoma, Nasopharyngeal carcinoma or Stage III or IV Non Hodgkin Lymphoma Relapsed or refractory disease following prior systemic therapies known to confer medical benefit Willing to provide a tumor sample (archive tissue or fresh biopsy) ECOG performance status 0 or 1 Measurable disease per RECIST v1.1 for RCC and NPC and per Lugano for NHL Exclusion Criteria: Prior treatment with anti-CD70 directed therapy Other malignancy within 3 years Active CNS metastases (treated, stable CNS metastases are allowed) Uncontrolled Grade 3 or greater infection within 2 weeks Positive for HBV, HCV or HIV Use of a strong P450 CYP3A inhibitor within 14 days (dose escalation only) Additional protocol defined inclusion/exclusion criteria may apply

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRO1160<br>PRO1160 monotherapy in escalating doses in Part A and at the recommended phase 2 dose in Part B | Drug: PRO1160<br>* Intravenous infusion of PRO1160<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events | Type, incidence, severity, and seriousness of adverse events | Through end of treatment, up to approximately 1 year | 
| Dose limiting toxicity | The proportion of patients experiencing dose limiting toxicities | Through end of treatment, up to approximately 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate | Patients who achieve partial or complete response per RECIST v1.1 criteria (RCC and NPC) and Lugano Classification 2014 (NHL) | Through end of treatment, up to approximately 1 year | 
| Disease Control Rate | Patients who achieve stable disease, partial or complete response per RECIST v1.1 criteria (RCC and NPC) and Lugano Classification 2014 (NHL) | Through end of treatment, up to approximately 1 year | 
| Progression-free survival | Time from start of treatment to first documented disease progression or death | Up to approximately 18 months | 
| Duration of objective response | Time from the first documentation of an objective tumor response (CR or PR) to the first documented tumor progression or death | From date of enrollment until the date of first documented disease progression or date of study withdrawal, whichever came first, assessed up to 12 months | 
| Peak Plasma Concentration (Cmax) for PRO1160 | Measurement of maximum plasma concentration after the administration of PRO1160 | Through end of treatment, up to approximately 1 year |