Non Hodgkin Lymphoma Clinical Trial

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

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 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.

Renal Cell Carcinoma (RCC) Drug: PRO1160 Phase 1/Phase 2 Nasopharyngeal Carcinoma (NPC) Non-Hodgkin Lymphoma (NHL)

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Full 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.

View Eligibility Criteria

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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

134

Study ID:

NCT05721222

Recruitment Status:

Recruiting

Sponsor:

ProfoundBio US Co.

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There are 14 Locations for this study

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City of Hope
Duarte California, 91010, United States More Info
Swetha Kambhampati, MD
Contact
[email protected]
City of Hope- Lennar
Irvine California, 92618, United States More Info
Swetha Kambhampati, MD
Contact
[email protected]
University of Michigan
Ann Arbor Michigan, 48109, United States More Info
Ulka Vaishampayan, MD
Contact
Karmanos Cancer Institute
Detroit Michigan, 48085, United States More Info
Elizabeth Heath, MD
Contact
[email protected]
Washington University
Saint Louis Missouri, 63110, United States More Info
Melissa Reimers, MD
Contact
[email protected]
Albert Einstein Montefiore
Bronx New York, 10461, United States More Info
Noah Kornblum, MD
Contact
[email protected]
NYU Lagone Health
New York New York, 10016, United States More Info
Catherine Diefenbach, MD
Contact
Levine Cancer Institute
Charlotte North Carolina, 28204, United States More Info
Steven Park, MD
Contact
[email protected]
Cleveland Clinic
Cleveland Ohio, 44195, United States More Info
Paolo Caimi, MD
Contact
Providence Cancer Institute
Portland Oregon, 97213, United States More Info
Brendan Curti, MD
Contact
503-215-5696
[email protected]
OHSU
Portland Oregon, 97239, United States More Info
Stephen Spurgeon, MD
Contact
Sarah Canon Research Institute
Nashville Tennessee, 37203, United States More Info
Ben Garmezy, MD
Contact
713-444-7804
[email protected]
The University of Texas-MD Anderson Cncer Center
Houston Texas, 77030, United States More Info
Eric Jonasch, MD
Contact
713-563-7323
[email protected]
START Mountain Region
West Valley City Utah, 84119, United States More Info
Justin Call, MD
Contact
801-907-4750
[email protected]
Cancer Hospital Chinese Academy of Medical Science
Beijing Beijing, , China More Info
Ning Li
Contact
[email protected]
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou Guangzhou, , China More Info
Weidong Li, MD
Contact
[email protected]
Sun Yat-sen University Cancer Prevention Center
Guangzhou Guangzhou, , China More Info
Li Zhang, MD
Contact
[email protected]
Fudan University Shanghai Cancer Center
Shanghai Shanghai, , China More Info
Dingwei Ye, MD
Contact
[email protected]
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai Shanghai, , China More Info
Weili Zhao, MD
Contact
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

134

Study ID:

NCT05721222

Recruitment Status:

Recruiting

Sponsor:


ProfoundBio US Co.

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