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

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ClinicalTrials.gov Identifier: NCT05721222
Recruitment Status : Recruiting
First Posted : February 9, 2023
Last Update Posted : September 15, 2023
Sponsor:
Information provided by (Responsible Party):
ProfoundBio US Co.

Study Description
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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).


Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Nasopharyngeal Carcinoma Non Hodgkin Lymphoma Drug: PRO1160 Phase 1 Phase 2

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 134 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1/2 Study of PRO1160 in Patients With Renal Cell Carcinoma (RCC), Nasopharyngeal Carcinoma (NPC), or Non-Hodgkin Lymphoma (NHL)
Actual Study Start Date : March 15, 2023
Estimated Primary Completion Date : April 30, 2024
Estimated Study Completion Date : April 30, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: PRO1160
PRO1160 monotherapy in escalating doses in Part A and at the recommended phase 2 dose in Part B
 Drug: PRO1160
Intravenous infusion of PRO1160


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: Through end of treatment, up to approximately 1 year ]
    Type, incidence, severity, and seriousness of adverse events

  2. Dose limiting toxicity [ Time Frame: Through end of treatment, up to approximately 1 year ]
    The proportion of patients experiencing dose limiting toxicities


Secondary Outcome Measures :
  1. Objective Response Rate [ Time Frame: Through end of treatment, up to approximately 1 year ]
    Patients who achieve partial or complete response per RECIST v1.1 criteria (RCC and NPC) and Lugano Classification 2014 (NHL)

  2. Disease Control Rate [ Time Frame: Through end of treatment, up to approximately 1 year ]
    Patients who achieve stable disease, partial or complete response per RECIST v1.1 criteria (RCC and NPC) and Lugano Classification 2014 (NHL)

  3. Progression-free survival [ Time Frame: Up to approximately 18 months ]
    Time from start of treatment to first documented disease progression or death

  4. Duration of objective response [ Time Frame: From date of enrollment until the date of first documented disease progression or date of study withdrawal, whichever came first, assessed up to 12 months ]
    Time from the first documentation of an objective tumor response (CR or PR) to the first documented tumor progression or death

  5. Peak Plasma Concentration (Cmax) for PRO1160 [ Time Frame: Through end of treatment, up to approximately 1 year ]
    Measurement of maximum plasma concentration after the administration of PRO1160


Other Outcome Measures:
  1. Immunogenic potential of PRO1160 [ Time Frame: Through end of treatment, up to approximately 1 year ]
    Assessment of anti-drug antibodies


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05721222


Contacts
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Contact: ProfoundBio Trial Support 1-844-774-4232 clinicaltrialinfo@profoundbio.com

Locations
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Sponsors and Collaborators
ProfoundBio US Co.
More Information
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Responsible Party: ProfoundBio US Co.
ClinicalTrials.gov Identifier: NCT05721222    
Other Study ID Numbers: PRO1160-001
First Posted: February 9, 2023    Key Record Dates
Last Update Posted: September 15, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Carcinoma
Lymphoma, Non-Hodgkin
Carcinoma, Renal Cell
Nasopharyngeal Carcinoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Glandular and Epithelial
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
 Urogenital Neoplasms
Neoplasms by Site
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Kidney Diseases
Urologic Diseases
Male Urogenital Diseases
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases