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COMPLETEDPHASE1

A Phase 1, Dose Finding Study of CC-90002 in Subjects With Advanced Solid and Hematologic Cancers

A Phase I, Open-Label, Dose Finding Study of CC-90002, a Monoclonal Antibody Directed Against CD47, in Subjects With Advanced Solid and Hematologic Cancers

NCT02367196•Celgene

View on ClinicalTrials.gov

Summary

CC-90002-ST -001 is an open-label, Phase 1, dose escalation clinical study in subjects with advanced, refractory solid and hematologic cancers.

Detailed Description

CC-90002-ST-001 is an open-label, Phase 1, dose escalation, first in human (FIH) clinical study of CC-90002, administered by intravenous (IV) infusion, in subjects with advanced, refractory solid and hematologic cancers. The study will be conducted in two parts. Part A dose escalation phase will explore escalating dose cohorts of the study drug CC-90002. Part B dose escalation will explore escalating doses of CC-90002 in combination with rituximab in subjects with CD20-positive NHL.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Men and women, 18 years or older, with advanced, relapsed or refractory solid tumors, Multiple Myeloma (MM) or non-Hodgkin's lymphoma (NHL) in Part A. In Part B, relapsed and/or refractory CD20-positive NHL subjects only.
•2. At least one site of measurable disease in subjects with solid tumors and NHL.
•3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
•4. Subjects must have adequate hematopoietic, liver, renal and coagulation function as assessed by specific laboratory criteria.
•5. Females and males must agree to contraceptive methods and avoid conceiving throughout the study, and for up to 8 weeks following the last dose of CC-90002. If participating in Part B, females of child bearing potential should continue to use effective contraceptive methods for 12 months following treatment with rituximab

Exclusion Criteria

•1. High grade lymphomas (Burkitts or lymphoblastic), plasma cell leukemia.
•2. High grade, rapidly proliferative solid tumors (eg, small cell lung cancer, germ cell tumors, neuroblastoma) with extensive tumor burden.
•3. Symptomatic central nervous system involvement.
•4. Impaired cardiac function or clinically significant cardiac disease.
•5. Prior Red blood cell (RBC) transfusion \< 3 months prior to starting CC-90002 (Part A only).
•6. Prior autologous stem cell transplant ≤ 3 months prior to starting CC-90002.
•7. Prior allogeneic stem cell transplant with either standard or reduced intensity conditioning ≤ 6 months prior to starting CC-90002.
•8. Prior systemic cancer-directed treatments or investigational modalities ≤ 5 half lives or 4 weeks prior to starting CC-90002, whichever is shorter.
•9. Major surgery ≤ 2 weeks prior to starting CC-90002.
•10. Pregnant or nursing females.
+6 more criteria

Locations (13)

Scottsdale Healthcare Research Institute

Scottsdale, Arizona, United States

University of Arizona Cancer Center

Tucson, Arizona, United States

University of California San Francisco

San Francisco, California, United States

Yale University School of Medicine

New Haven, Connecticut, United States

South Texas Accelerated Research Therapeutics

San Antonio, Texas, United States

Hospital Universitari Germans Trias i Pujol Can Ruti

Badalona (Barcelona), Spain

Hospital Val d'Hebron

Barcelona, Spain

Duran i Reynals Institut Catala d'Oncologia

Barcelona, Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain

Hospital 12 de Octubre

Madrid, Spain

Key Dates

Start Date

March 12, 2015

Primary Completion Date

December 24, 2020

Completion Date

December 24, 2020

Last Updated

August 12, 2021

Enrollment

ACTUAL participants

Conditions

Hematologic Neoplasms

Interventions

CC-90002

DRUG

Rituximab

DRUG

Prospective Validation of the OHI Index

NCT05882175

HLHHemophagocytic Lymphohistiocytoses+3 more

View study

RECRUITING

UWCCC Molecular Tumor Board Registry

NCT03023202

Hematologic NeoplasmsSolid Neoplasm

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 12, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase 1, Dose Finding Study of CC-90002 in Subjects With Advanced Solid and Hematologic Cancers

Inclusion Criteria

Exclusion Criteria

Prospective Validation of the OHI Index

UWCCC Molecular Tumor Board Registry

The ACC Preclinical Research Platform for Precision Oncology

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