[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

How to apply

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Study’s contact

Email address

glenn.michelson@catalystcr.com

Condition

Nasopharyngeal Carcinoma,Non Hodgkin Lymphoma,Renal Cell Carcinoma

Treatment type

Interventional

Investigational product

PRO1160

Phase

Phase 1/Phase 2

Sponsor

ProfoundBio US Co.

ClinicalTrials.gov identifier

NCT05721222

Study number

PRO1160-001

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About the study

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)

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

  1. Pathologically confirmed metastatic or unresectable solid malignancy including Renal Cell carcinoma, Nasopharyngeal carcinoma or Stage III or IV Non Hodgkin Lymphoma
  2. Relapsed or refractory disease following prior systemic therapies known to confer medical benefit
  3. Willing to provide a tumor sample (archive tissue or fresh biopsy)
  4. ECOG performance status 0 or 1
  5. Measurable disease per RECIST v1.1 for RCC and NPC and per Lugano for NHL
Exclusion criteria

  1. Prior treatment with anti-CD70 directed therapy
  2. Other malignancy within 3 years
  3. Active CNS metastases (treated, stable CNS metastases are allowed)
  4. Uncontrolled Grade 3 or greater infection within 2 weeks
  5. Positive for HBV, HCV or HIV
  6. Use of a strong P450 CYP3A inhibitor within 14 days (dose escalation only)
  7. Additional protocol defined inclusion/exclusion criteria may apply

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.

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