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A Trial of PF-07901800 (TTI-621) for Patients With Hematologic Malignancies and Selected Solid Tumors

TerminatedPhase 1

Sponsor: Pfizer

Conditions: Hematologic Malignancies, Solid Tumor

Interventions: PF-0791800 (TTI-621), PF-07901800 (TTI-621) plus Rituximab, PF-07901800 (TTI-621) plus Nivolumab

Countries: United States, Canada

Multicenter, open-label, phase 1a/1b trial of PF-07901800 (TTI-621) in subjects with relapsed or refractory hematologic malignancies and selected solid tumors.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (51)

Duarte, California, United States
Duarte, California, United States
Palo Alto, California, United States
Palo Alto, California, United States
Denver, Colorado, United States
Denver, Colorado, United States
Jacksonville, Florida, United States
Jacksonville, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Greenfield, Indiana, United States
Rochester, Minnesota, United States
Hackensack, New Jersey, United States
Hackensack, New Jersey, United States
Hackensack, New Jersey, United States
Middletown, New Jersey, United States
Harrison, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Cleveland, Ohio, United States
Cleveland, Ohio, United States
Portland, Oregon, United States
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