PF-06863135 As Single Agent And In Combination With Immunomodulatory Agents In Relapse/Refractory Multiple Myeloma

Pfizer

Status and phase: Completed; Phase 1

Conditions: Multiple Myeloma

Treatments: Drug: PF-06863135 + lenalidomide; Drug: PF-06863135 + pomalidomide; Drug: PF-06863135 + dexamethasone; Drug: PF-06863135 monotherapy IV or SC

Study type: Interventional

Funder types: Industry

Identifiers

NCT03269136

2019-000822-24 (EudraCT Number)

C1071001

Details and patient eligibility

About

To assess the safety and tolerability at increasing dose levels of PF-06863135 in patients with relapse/ refractory multiple myeloma in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.

Full description

Study C1071001 is a Phase 1, open label, multi dose, multi center, dose escalation, safety, pharmacokinetic (PK) and pharmacodynamic study of PF-06863135 in adult patients with advanced multiple myeloma who have relapsed from or are refractory to standard therapy. This is a two part study; Part 1 will assess the safety and tolerability of increasing dose levels of PF-06863135 and Part 2 will evaluate safety and anti-myeloma activity of PF-06863135 at the RP2Ds determined in Part 1.

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Relapsed/refractory multiple myeloma
• Progressed or are intolerant of established therapies including proteasome inhibitor, immunomodulatory drug, and anti-CD38 antibody
• Performance Status of 0- 1 ( Performance Score 2 is permitted only if due to underlying myeloma)
• Adequate bone marrow, hematological, kidney and liver function
• Resolved acute effects of any prior therapy to baseline severity
• Not pregnant

Exclusion criteria

• Recent history of other malignancies
• History of active autoimmune disorders
• Any form of primary immunodeficiency
• Active and clinically significant bacterial, fungal, or viral infection
• Evidence of active mucosal or internal bleeding
• History of severe immune-mediated adverse event with prior immunomodulatory treatment
• Major surgery within 4 weeks of study treatment start
• Radiation therapy within 2 weeks of study treatment start
• History of stem cell transplant (autologous or allogeneic) within 100 days prior to study enrollment
• Donor Lymphocyte Infusion (DLI) within 30 days prior to study entry
• Less than 30 days since last dose of antibody based therapies or less than 5 half-lives since last dose of previous therapy
• Requirement for systemic immune suppressive medication except as permitted in the protocol
• Current requirement for chronic blood product support

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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101 participants in 4 patient groups

PF-06863135

Experimental group

Description:

BCMA-CD3 bispecific antibody

Treatment:

Drug: PF-06863135 monotherapy IV or SC

PF-06863135 + dexamethasone

Experimental group

Description:

BCMA-CD3 bispecific antibody + dexamethasone

Treatment:

Drug: PF-06863135 + dexamethasone

PF-06863135 + lenalidomide

Experimental group

Description:

BCMA-CD3 bispecific antibody + lenalidomide

Treatment:

Drug: PF-06863135 + lenalidomide

PF-06863135 + pomalidomide

Experimental group

Description:

BCMA-CD3 bispecific antibody + pomalidomide

Treatment:

Drug: PF-06863135 + pomalidomide