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).
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).
Brief Title
PRO1160 for Advanced Solid and Liquid Tumors (PRO1160-001)
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.
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.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
1-844-774-4232
Central Contact Email
clinicaltrialinfo@profoundbio.com
Completion Date
Completion Date Type
Estimated
Conditions
Renal Cell Carcinoma
Nasopharyngeal Carcinoma
Non Hodgkin Lymphoma
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
* 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
Inclusion 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
inclusion/
* 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
inclusion/
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT05721222
Org Class
Industry
Org Full Name
ProfoundBio US Co.
Org Study Id
PRO1160-001
Overall Status
Recruiting
Phases
Phase 1
Phase 2
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Phase 1/2 Study of PRO1160 in Patients With Renal Cell Carcinoma (RCC), Nasopharyngeal Carcinoma (NPC), or Non-Hodgkin Lymphoma (NHL)
Primary Outcomes
Outcome Description
Type, incidence, severity, and seriousness of adverse events
Outcome Measure
Incidence of Treatment-Emergent Adverse Events
Outcome Time Frame
Through end of treatment, up to approximately 1 year
Outcome Description
The proportion of patients experiencing dose limiting toxicities
Outcome Measure
Dose limiting toxicity
Outcome Time Frame
Through end of treatment, up to approximately 1 year
Secondary Outcomes
Outcome Description
Patients who achieve partial or complete response per RECIST v1.1 criteria (RCC and NPC) and Lugano Classification 2014 (NHL)
Outcome Time Frame
Through end of treatment, up to approximately 1 year
Outcome Measure
Objective Response Rate
Outcome Description
Patients who achieve stable disease, partial or complete response per RECIST v1.1 criteria (RCC and NPC) and Lugano Classification 2014 (NHL)
Outcome Time Frame
Through end of treatment, up to approximately 1 year
Outcome Measure
Disease Control Rate
Outcome Description
Time from start of treatment to first documented disease progression or death
Outcome Time Frame
Up to approximately 18 months
Outcome Measure
Progression-free survival
Outcome Description
Time from the first documentation of an objective tumor response (CR or PR) to the first documented tumor progression or death
Outcome 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
Outcome Measure
Duration of objective response
Outcome Description
Measurement of maximum plasma concentration after the administration of PRO1160
Outcome Time Frame
Through end of treatment, up to approximately 1 year
Outcome Measure
Peak Plasma Concentration (Cmax) for PRO1160
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Noah Kornblum
Investigator Email
nkornblu@montefiore.org
Investigator Phone
718-920-4826