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

Conditions

• Hematologic Malignancies
• Solid Tumor

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• PF-0791800 (TTI-621) — DRUG
  Monotherapy
• PF-07901800 (TTI-621) plus Rituximab — DRUG
  Combination therapy
• PF-07901800 (TTI-621) plus Nivolumab — DRUG
  Combination therapy

Study Details

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

Key Dates

Start date

Jan 28, 2016

Status verified

Nov 2023

Primary completion

Nov 23, 2022

Completion

Nov 23, 2022

Study Design

Enrollment

249 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: PF-07901800 (TTI-621) Escalation Phase - R/R Lymphoma
  The Escalation Phase will include multiple doses of PF-07901800 (TTI-621)
• Experimental: Indolent B-Cell Lymphoma
  Monotherapy expansion cohort with PF-07901800 (TTI-621)
• Experimental: Aggressive B-Cell Lymphoma
  Monotherapy expansion cohort with PF-07901800 (TTI-621)
• Experimental: T-Cell Lymphoma
  Monotherapy expansion cohort with PF-07901800 (TTI-621)
• Experimental: Hodgkin Lymphoma
  Monotherapy expansion cohort with PF-07901800 (TTI-621)
• Experimental: Chronic Lymphocytic Leukemia
  Monotherapy expansion cohort with PF-07901800 (TTI-621)
• Experimental: Multiple Myeloma
  Monotherapy expansion cohort with PF-07901800 (TTI-621)
• Experimental: Acute Myeloid Leukemia
  Monotherapy expansion cohort with PF-07901800 (TTI-621)
• Experimental: Myelodysplastic Syndrome
  Monotherapy expansion cohort with PF-07901800 (TTI-621)
• Experimental: Myeloproliferative Neoplasms
  Monotherapy expansion cohort with PF-07901800 (TTI-621)
• Experimental: Small Cell Lung Cancer
  Monotherapy expansion cohort with PF-07901800 (TTI-621)
• Experimental: Rituximab Combination
  Combination therapy expansion cohort with PF-07901800 (TTI-621) plus Rituximab for CD20 positive malignancies
• Experimental: Nivolumab Combination
  Combination therapy expansion cohort with PF-07901800 (TTI-621) plus Nivolumab for Hodgkin Lymphoma
• Experimental: Cutaneous T-Cell Lymphoma (CTCL)
  Monotherapy expansion cohort with PF-07901800 (TTI-621)
• Experimental: Peripheral T-Cell Lymphoma (PTCL)
  Monotherapy expansion cohort with PF-07901800 (TTI-621)
• Experimental: Part 4: Cutaneous T-Cell Lymphoma (CTCL)
  Monotherapy expansion Part 4 (Dose Optimization) cohort with PF-07901800 (TTI-621)

Primary Outcome Measure

Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) [ Time Frame: Part 1: Day 1 of dosing up to 30 days of safety follow-up visit after the last dose (maximum treatment exposure for Part 1 was 414 days) ]

Locations (47)

Find similar trials in Duarte, CA

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