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

Primary Purpose

Renal Cell Carcinoma, Nasopharyngeal Carcinoma, Non Hodgkin Lymphoma

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
PRO1160
Sponsored by
ProfoundBio US Co.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • City of HopeRecruiting
  • City of Hope- LennarRecruiting
  • University of Michigan
  • Karmanos Cancer Institute
  • Washington UniversityRecruiting
  • Albert Einstein Montefiore
  • NYU Lagone Health
  • Levine Cancer InstituteRecruiting
  • Cleveland ClinicRecruiting
  • Providence Cancer InstituteRecruiting
  • OHSU
  • Sarah Canon Research InstituteRecruiting
  • The University of Texas-MD Anderson Cncer Center
  • START Mountain RegionRecruiting
  • Cancer Hospital Chinese Academy of Medical Science
  • Affiliated Cancer Hospital and Institute of Guangzhou Medical University
  • Sun Yat-sen University Cancer Prevention Center
  • Fudan University Shanghai Cancer CenterRecruiting
  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PRO1160

Arm Description

PRO1160 monotherapy in escalating doses in Part A and at the recommended phase 2 dose in Part B

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events
Type, incidence, severity, and seriousness of adverse events
Dose limiting toxicity
The proportion of patients experiencing dose limiting toxicities

Secondary Outcome Measures

Objective Response Rate
Patients who achieve partial or complete response per RECIST v1.1 criteria (RCC and NPC) and Lugano Classification 2014 (NHL)
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)
Progression-free survival
Time from start of treatment to first documented disease progression or death
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
Peak Plasma Concentration (Cmax) for PRO1160
Measurement of maximum plasma concentration after the administration of PRO1160

Full Information

First Posted
January 31, 2023
Last Updated
September 29, 2023
Sponsor
ProfoundBio US Co.
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1. Study Identification

Unique Protocol Identification Number
NCT05721222
Brief Title
PRO1160 for Advanced Solid and Liquid Tumors (PRO1160-001)
Official Title
Phase 1/2 Study of PRO1160 in Patients With Renal Cell Carcinoma (RCC), Nasopharyngeal Carcinoma (NPC), or Non-Hodgkin Lymphoma (NHL)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2023 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ProfoundBio US Co.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma, Nasopharyngeal Carcinoma, Non Hodgkin Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
134 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PRO1160
Arm Type
Experimental
Arm Description
PRO1160 monotherapy in escalating doses in Part A and at the recommended phase 2 dose in Part B
Intervention Type
Drug
Intervention Name(s)
PRO1160
Intervention Description
Intravenous infusion of PRO1160
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events
Description
Type, incidence, severity, and seriousness of adverse events
Time Frame
Through end of treatment, up to approximately 1 year
Title
Dose limiting toxicity
Description
The proportion of patients experiencing dose limiting toxicities
Time Frame
Through end of treatment, up to approximately 1 year
Secondary Outcome Measure Information:
Title
Objective Response Rate
Description
Patients who achieve partial or complete response per RECIST v1.1 criteria (RCC and NPC) and Lugano Classification 2014 (NHL)
Time Frame
Through end of treatment, up to approximately 1 year
Title
Disease Control Rate
Description
Patients who achieve stable disease, partial or complete response per RECIST v1.1 criteria (RCC and NPC) and Lugano Classification 2014 (NHL)
Time Frame
Through end of treatment, up to approximately 1 year
Title
Progression-free survival
Description
Time from start of treatment to first documented disease progression or death
Time Frame
Up to approximately 18 months
Title
Duration of objective response
Description
Time from the first documentation of an objective tumor response (CR or PR) to the first documented tumor progression or death
Time Frame
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
Title
Peak Plasma Concentration (Cmax) for PRO1160
Description
Measurement of maximum plasma concentration after the administration of PRO1160
Time Frame
Through end of treatment, up to approximately 1 year
Other Pre-specified Outcome Measures:
Title
Immunogenic potential of PRO1160
Description
Assessment of anti-drug antibodies
Time Frame
Through end of treatment, up to approximately 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ProfoundBio Trial Support
Phone
1-844-774-4232
Email
clinicaltrialinfo@profoundbio.com
Facility Information:
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Swetha Kambhampati, MD
Email
skambhampati@coh.org
Facility Name
City of Hope- Lennar
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Swetha Kambhampati, MD
Email
skambhampati@coh.org
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulka Vaishampayan, MD
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Heath, MD
Email
heathe@karmanos.com
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Reimers, MD
Email
mreimers@wustl.edu
Facility Name
Albert Einstein Montefiore
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noah Kornblum, MD
Email
nkornblu@montefiore.org
Facility Name
NYU Lagone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Diefenbach, MD
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Park, MD
Email
Steven.Park@atriumhealth.org
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paolo Caimi, MD
Facility Name
Providence Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brendan Curti, MD
Phone
503-215-5696
Email
brendan.curti@providence.org
Facility Name
OHSU
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Spurgeon, MD
Facility Name
Sarah Canon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ben Garmezy, MD
Phone
713-444-7804
Email
benjamin.garmezy@sarahcannon.com
Facility Name
The University of Texas-MD Anderson Cncer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Jonasch, MD
Phone
713-563-7323
Email
ejonasch@mdanderson.org
Facility Name
START Mountain Region
City
West Valley City
State/Province
Utah
ZIP/Postal Code
84119
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justin Call, MD
Phone
801-907-4750
Email
jcall@utahcancer.com
Facility Name
Cancer Hospital Chinese Academy of Medical Science
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ning Li
Email
Lining@cicams.ac.cn
Facility Name
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
City
Guangzhou
State/Province
Guangzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weidong Li, MD
Email
lwdlyn_hky@126.com
Facility Name
Sun Yat-sen University Cancer Prevention Center
City
Guangzhou
State/Province
Guangzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Zhang, MD
Email
zhangli@sysucc.org.cn
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dingwei Ye, MD
Email
fuscc2012@163.com
Facility Name
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weili Zhao, MD
Email
zwl_trial@163.com

12. IPD Sharing Statement

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

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