Neoplasms

All Conditions

Blood and Lymph Conditions

Immune System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Carcinoma

Lymphoma

Carcinoma, Renal Cell

Nasopharyngeal Carcinoma

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Neoplasms, Glandular and Epithelial

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Nasopharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Lymphosarcoma

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

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

PRO1160

ProfoundBio Trial Support

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 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.

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

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

Type, incidence, severity, and seriousness of adverse events

The proportion of patients experiencing dose limiting toxicities

Patients who achieve partial or complete response per RECIST v1.1 criteria (RCC and NPC) and Lugano Classification 2014 (NHL)

Patients who achieve stable disease, partial or complete response per RECIST v1.1 criteria (RCC and NPC) and Lugano Classification 2014 (NHL)

Time from start of treatment to first documented disease progression or death

Time from the first documentation of an objective tumor response (CR or PR) to the first documented tumor progression or death

Measurement of maximum plasma concentration after the administration of PRO1160

ProfoundBio US Co.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PRO1160 for Advanced Solid and Liquid Tumors (PRO1160-001)	NCT05721222	Renal Cell Carc... Nasopharyngeal ... Non Hodgkin Lym...	PRO1160	18 Years -	ProfoundBio US Co.
PRO1160 for Advanced Solid and Liquid Tumors (PRO1160-001)	NCT05721222	Renal Cell Carc... Nasopharyngeal ... Non Hodgkin Lym...	PRO1160	18 Years -	ProfoundBio US Co.
PRO1160 for Advanced Solid and Liquid Tumors (PRO1160-001)	NCT05721222	Renal Cell Carc... Nasopharyngeal ... Non Hodgkin Lym...	PRO1160	18 Years -	ProfoundBio US Co.

Spots Global Cancer Trial Database for pro1160

Every month we try and update this database with for pro1160 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pro1160

Every month we try and update this database with for pro1160 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pro1160 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.