Testing PRO1160 for advanced solid and liquid tumors
Phase 1/2 Study of PRO1160 in Patients With Renal Cell Carcinoma (RCC), Nasopharyngeal Carcinoma (NPC), or Non-Hodgkin Lymphoma (NHL)
This study is testing a new drug called PRO1160 to see if it can safely help people with advanced cancers that can't be surgically removed.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 134 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | ProfoundBio US Co. Industry-sponsored |
| Locations | 17 sites (Duarte, California and 16 other locations) |
| Trial ID | NCT05721222 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of a drug called PRO1160 in patients with advanced solid tumors and liquid cancers that cannot be surgically removed. The study is divided into two parts: Part A focuses on determining the appropriate dosage and frequency of PRO1160, while Part B assesses its safety and efficacy based on the findings from Part A. Participants must have confirmed metastatic or unresectable cancers, including renal cell carcinoma, nasopharyngeal carcinoma, or non-Hodgkin lymphoma. The trial will involve administering the drug via IV infusion over a 21-day cycle until disease progression or other specified criteria are met.
Who should consider this trial
Good fit: Ideal candidates include individuals with metastatic or unresectable renal cell carcinoma, nasopharyngeal carcinoma, or non-Hodgkin lymphoma who have relapsed or refractory disease.
Not a fit: Patients with active CNS metastases or those who have previously received anti-CD70 directed therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could provide a new treatment option for patients with advanced cancers that are difficult to treat.
How similar studies have performed: Other studies using targeted antibody-drug conjugates have shown promise, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Duarte, California and 16 other locations
- City of Hope Comprehensive Cancer Center - Duarte — Duarte, California, United States (Recruiting)
- The City of Hope Orange County Lennar Foundation Cancer Center — Irvine, California, United States (Recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
- Karmanos Cancer Institute — Detroit, Michigan, United States (Recruiting)
- Washington University School of Medicine in St. Louis — Saint Louis, Missouri, United States (Recruiting)
- Montefiore Medical Center - Montefiore Hospital — Bronx, New York, United States (Recruiting)
- NYU Langone Health — New York, New York, United States (Recruiting)
- Levine Cancer Center — Charlotte, North Carolina, United States (Recruiting)
- Cleveland Clinic - Euclid Hospital — Cleveland, Ohio, United States (Recruiting)
- Providence Portland Medical Center — Portland, Oregon, United States (Recruiting)
- Oregon Health & Science University — Portland, Oregon, United States (Recruiting)
- Sarah Cannon Research Institute - Nashville — Nashville, Tennessee, United States (Recruiting)
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- START Mountain Cancer Center — West Valley City, Utah, United States (Recruiting)
- Cancer Hospital of Chinese Academy of Medical Sciences — Beijing, Beijing, China (Recruiting)
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai, China (Recruiting)
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Study coordinator: ProfoundBio Trial Support
- Email: clinicaltrialinfo@profoundbio.com
- Phone: 1-844-774-4232
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.