An Open-Label Phase 1 Study to Evaluate PF-07994525 in Participants With Advanced Malignancies PF-07994525

What's the purpose of this trial?

This is an open-label, dose escalation and dose expansion study evaluating the safety, tolerability, Pharmacokinetic (PK), Pharmacodynamic (PD), and antitumor activity of PF-07994525 in participants with R/R MM. The study will consist of 2 parts: Part 1 (Dose Escalation) will consist of PF-07994525 dose escalation to assess the safety, tolerability, and preliminary antitumor activity in participants with R/R MM. In Part 2 (Dose expansion), PF-07994525 may be evaluated in additional participants with R/R MM to further assess safety, PK, PD, and preliminary anti-tumor activity.

This trial is currently open and accepting patients.


You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria:

  • Participants with a cancer diagnosis: Documentation of disease:

    • Histologic documentation: Histologically confirmed diagnosis of invasive cancer
    • Stage: Stage I-IV per American Joint Committee on Cancer (AJCC) 7th edition, with the exception of patients with leukemia, lymphoma, and multiple myeloma

      ** For leukemia: Type (chronic lymphocytic leukemia [CLL], chronic myeloid leukemia [CML], acute lymphoblastic lymphoma [ALL], acute myeloid leukemia [AML])

      • For lymphoma (any type): Stage I-IV based on Ann Arbor staging
      • For multiple myeloma: Stage I, II, III based on Revised International Staging System (RISS)
    • One of the following tumor types (synchronous cancers are not allowed and all neuroendocrine tumors are excluded):

      • Colorectal
      • Bladder
      • Head and neck
      • Hepatobiliary

        *** For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment

      • Lung
      • Lymphoma
      • Leukemia
      • Ovary *** For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment
      • Pancreas

        *** For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment

      • Multiple myeloma
      • Gastric, esophageal or gastroesophageal
      • Breast
      • Thyroid
      • Kidney

        *** For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment

      • Endometrium

        *** For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment

      • Prostate
  • Participants with a cancer diagnosis: No prior definitive systemic or local anti-cancer intervention (including surgical excision)
  • Participants with a cancer diagnosis: Age >= 40 and =< 75
  • Participants with a cancer diagnosis: No known current pregnancy by self-report
  • Participants with a cancer diagnosis: No known or prior history of in situ or invasive malignancy other than the current cancer diagnosis. Non-melanoma skin cancers (such as basal or squamous cell) are allowed.
  • Participants with a cancer diagnosis: Willingness to provide blood samples for research use
  • Participants with a cancer diagnosis: Absence of medical contraindications to a research blood draw volume of 60 mL
  • Participants with a cancer diagnosis: No history of organ transplantation
  • Participants with a cancer diagnosis: Ability to read and comprehend English or Spanish

    * Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages

  • Participants without a cancer diagnosis and without suspicion of cancer: Age >= 40 and =< 75
  • Participants without a cancer diagnosis and without suspicion of cancer: No known current pregnancy by self-report
  • Participants without a cancer diagnosis and without suspicion of cancer: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers)
  • Participants without a cancer diagnosis and without suspicion of cancer: Willingness to provide blood samples for research use
  • Participants without a cancer diagnosis and without suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL
  • Participants without a cancer diagnosis and without suspicion of cancer: No history of organ transplantation
  • Participants without a cancer diagnosis and without suspicion of cancer: Ability to read and comprehend English or Spanish

    * Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages

  • Participants with a high suspicion of cancer: High suspicion of ovarian cancer, pancreatic cancer, kidney cancer, hepatobiliary cancer, endometrial cancer or melanoma by clinical and/or radiological assessment, with plans for histologic or cytologic confirmation within 28 days after study blood draw

    * Examples of highly suspicious cases include: elevated CA125 and abnormal transvaginal ultrasound, suspicious renal or pancreatic mass on imaging, suspicious cutaneous lesion concerning for melanoma

  • Participants with a high suspicion of cancer: Central review of radiology reports and/or clinical documentation conducted by study chairs
  • Participants with a high suspicion of cancer: Age >= 40 and =< 75
  • Participants with a high suspicion of cancer: No known current pregnancy by self-report
  • Participants with a high suspicion of cancer: No known or prior history of in situ or invasive malignancy. Non-melanoma skin cancers (such as basal or squamous cell) are allowed.
  • Participants with a high suspicion of cancer: Willingness to provide blood samples for research use
  • Participants with a high suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL
  • Participants with a high suspicion of cancer: No history or organ transplantation
  • Participants with a high suspicion of cancer: Ability to read and comprehend English or Spanish * Eligibility is restricted to individuals who can comprehend and read English and Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages

Additional Trial Information

Phase 1

Enrollment: 120 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Florida

Sylvester Comprehensive Cancer Center University of Miami

Coral Gables, FL

Open and Accepting

Sylvester Comprehensive Cancer Center

Coral Springs, FL

Open and Accepting

Sylvester Comprehensive Cancer Center University of Miami

Deerfield Beach, FL

Open and Accepting

Sylvester Comprehensive Cancer Center

Doral, FL

Open and Accepting

Sylvester Comprehensive Cancer Center at Hollywood

Hollywood, FL

Open and Accepting

Sylvester Comprehensive Cancer Center University of Miami - Kendall

Miami, FL

Open and Accepting

University of Miami - Sylvester Comprehensive Cancer Center - Plantation

Plantation, FL

Open and Accepting

Georgia

Winship Cancer Institute Emory University

Atlanta, GA

Open and Accepting

Emory University Winship Cancer Institute - Midtown

Atlanta, GA

Open and Accepting

Ohio

Tennessee

Sarah Cannon Research Institute TriStar Centennial Medical Center

Nashville, TN

Open and Accepting
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