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

Introduction

• Org Study ID: PRO1160-001
• NTC ID: NCT05721222
• Lead Sponsor Name: ProfoundBio US Co.
• Status: RECRUITING

Conditions

• Renal Cell Carcinoma

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).

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