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Phase 1/2 Study of PRO1160 in Patients with Metastatic Renal Cell Carcinoma (RCC), Metastatic or Relapsed Nasopharyngeal Carcinoma (NPC), or Advanced (Stage III or IV) Non-Hodgkin Lymphoma (NHL)
Cancer Categories
Genitourinary (GU),Hematologic (Blood Cancers),Lung
Karmanos Trial ID
2023-018
NCT ID
NCT05721222
Age Group
Adult
Scope
National
Phase
Phase I
Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
Phase I/II
Principal Investigator
Elisabeth
Heath, M.D., FACP
Oncology - Medical
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Objective:
Primary Objectives:
Evaluate the safety and tolerability of PRO1160
Identify the maximum tolerated dose (MTD), if reached, and the recommended Phase 2 dose (RP2D) of PRO1160
Secondary Objectives:
Assess the antitumor activity of PRO1160
Assess the pharmacokinetics (PK) of PRO1160
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Eligibility
Locations
Applicable Disease Site
Therapies | Drugs | Devices
Eligibility
Eligibility
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
Locations
Locations
Karmanos Cancer Institute - Detroit Headquarters
4100 John R
Detroit, MI 48201
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Phone:
800-527-6266
Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills
31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone:
800-527-6266
Applicable Disease Site
Applicable Disease Site
Kidney; Non-Hodgkin Lymphoma; Other Respiratory and Intrathoracic Organs
Therapies, Drugs, Devices
Therapies | Drugs | Devices
Therapies
Immunotherapy
Drugs
PRO1160
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