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A Trial of PF-07901800 (TTI-621) for Patients With Hematologic Malignancies and Selected Solid Tumors
Not Recruiting
Trial ID: NCT02663518
Purpose
Multicenter, open-label, phase 1a/1b trial of PF-07901800 (TTI-621) in subjects with relapsed
or refractory hematologic malignancies and selected solid tumors.
Official Title
A Phase 1a/1b Dose Escalation and Expansion Trial of PF-0791800 (TTI-621), a Novel Biologic Targeting CD47, in Subjects With Relapsed or Refractory Hematologic Malignancies and Selected Solid Tumors
Stanford Investigator(s)
Youn H Kim, MD
The Joanne and Peter Haas, Jr., Professor for Cutaneous Lymphoma Research and Professor, by courtesy, of Medicine (Oncology)
Eligibility
MAJOR ELIGIBILITY CRITERIA:
Phase 1a Escalation
• Histologically documented, measurable, advanced lymphomas, transfusion-independence
Phase 1b Expansion (Part 2 and 3) • Advanced malignancy: IBCL, ABCL, cHL, AML, ALL, MDS,
MPN, SCLC, PTCL and CTCL; measurable disease who have relapsed or are refractory following
at least 2 prior systemic therapeutic attempts (1 prior systemic attempt for PTCL). For
CTCL, extracorporeal photochemotherapy (ECP) considered a systemic therapy. Local radiation
and topical agents are not systemic therapies.
Phase 1b dose optimization (Part 4)
• Histologically confirmed diagnosis of CTCL (both Mycosis Fungoides and Sezary Syndrome):
Failed at least 2 prior systemic therapies for CTCL (Systemic therapy does not include
local radiation therapy or topical agents); History of histologically documented diagnosis
of CTCL stage IB to IVB
Inclusion Criteria (all subjects):
- Advanced measurable malignancy with previously progressed on, or currently progressing
on standard anticancer therapy or for whom no other approved conventional therapy
exists
- Eastern Cooperative Oncology Group (ECOG) 0-2
- Adequate hematologic, hepatic, renal, and coagulation function; fresh or archived
tumor tissue available for immunohistochemistry
- Recovery from prior treatments and/or surgeries; no history of hemolytic anemia or
bleeding diathesis.
- AML M3 (French American British, FAB, classification) (i.e., acute promyelocytic
leukemia [APL]) excluded
Exclusion Criteria:
- Known current central nervous system disease involvement or untreated brain metastases
- Allogeneic transplant within 30 days prior to the planned start of treatment or
subjects with active graft-vs-host disease with the exception of Grade 1 skin
involvement
- History of hemolytic anemia or bleeding diathesis
Intervention(s):
drug: PF-0791800 (TTI-621)
drug: PF-07901800 (TTI-621) plus Rituximab
drug: PF-07901800 (TTI-621) plus Nivolumab
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Elle (Hyunjin) Kim
650-387-4436