NCT02367196

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2015

Longer than P75 for phase_1

Geographic Reach
2 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 20, 2015

Completed
20 days until next milestone

Study Start

First participant enrolled

March 12, 2015

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2020

Completed
Last Updated

August 12, 2021

Status Verified

August 1, 2021

Enrollment Period

5.8 years

First QC Date

February 13, 2015

Last Update Submit

August 10, 2021

Conditions

Hematologic Neoplasms

Keywords

CC-90002MonoclonalAntibodyCD47AdvancedSolid CancersHematologic Cancers

Outcome Measures

Primary Outcomes (5)

  • Dose-Limiting Toxicity (DLT)

    Number of participants with a DLT

    Up to 18 months

  • Non-Tolerated Dose (NTD) - Part A

    Dose at which 2 or more of up to 6 evaluable subjects in any dose cohort experience a DLT in Cycle 1.

    Up to 18 months

  • Maximum Tolerated Dose (MTD) - Part A

    Dose that is the last dose level below the NTD with 0 or 1 out of 6 evaluable subjects experiencing a DLT during Cycle 1.

    Up to 18 months

  • Non-Tolerated Dose (NTD) - Part B

    Dose at which 2 or more of up to 6 evaluable subjects in any dose cohort experience a DLT in Cycle 1.

    Up to 24 months

  • Maximum Tolerated Dose (MTD) - Part B

    Dose that is the last dose level below the NTD with 0 or 1 out of 6 evaluable subjects experiencing a DLT during Cycle 1.

    Up to 24 months

Secondary Outcomes (10)

  • Antitumor efficacy

    Up to 36 months

  • Pharmacokinetics - Cmax

    Cycle 1 and beyond; and after discontinuation

  • Pharmacokinetics - AUC

    Cycle 1 and beyond; and after discontinuation

  • Pharmacokinetics - tmax

    Cycle 1 and beyond; and after discontinuation

  • Pharmacokinetics - T1/2

    Cycle 1 and beyond; and after discontinuation

  • +5 more secondary outcomes

Study Arms (2)

Part A: CC-90002

EXPERIMENTAL

CC-90002 will be given by intravenous (IV) infusion on a 28 day cycle

Drug: CC-90002

Part B: CC-90002 with Rituximab

EXPERIMENTAL

CC-90002 in combination with Rituximab will be given by intravenous (IV) infusion on a 28 day cycle in subjects with CD20-positive NHL

Drug: CC-90002Drug: Rituximab

Interventions

CC-90002DRUG
Part A: CC-90002Part B: CC-90002 with Rituximab
RituximabDRUG
Part B: CC-90002 with Rituximab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • At least one site of measurable disease in subjects with solid tumors and NHL.
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
  • Subjects must have adequate hematopoietic, liver, renal and coagulation function as assessed by specific laboratory criteria.
  • 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

You may not qualify if:

  • High grade lymphomas (Burkitts or lymphoblastic), plasma cell leukemia.
  • High grade, rapidly proliferative solid tumors (eg, small cell lung cancer, germ cell tumors, neuroblastoma) with extensive tumor burden.
  • Symptomatic central nervous system involvement.
  • Impaired cardiac function or clinically significant cardiac disease.
  • Prior Red blood cell (RBC) transfusion \< 3 months prior to starting CC-90002 (Part A only).
  • Prior autologous stem cell transplant ≤ 3 months prior to starting CC-90002.
  • Prior allogeneic stem cell transplant with either standard or reduced intensity conditioning ≤ 6 months prior to starting CC-90002.
  • Prior systemic cancer-directed treatments or investigational modalities ≤ 5 half lives or 4 weeks prior to starting CC-90002, whichever is shorter.
  • Major surgery ≤ 2 weeks prior to starting CC-90002.
  • Pregnant or nursing females.
  • Known HIV infection.
  • Known chronic, active hepatitis B or C (HBV/HCV) infection.
  • Ongoing treatment with chronic, therapeutic dosing of anti-coagulants.
  • History of autoimmune hemolytic anemia or autoimmune thrombocytopenia.
  • History of concurrent second cancers requiring active, ongoing systemic treatment.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Scottsdale Healthcare Research Institute

Scottsdale, Arizona, 85258, United States

Location

University of Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

University of California San Francisco

San Francisco, California, 94143-1270, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06520-8073, United States

Location

South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229, United States

Location

Hospital Universitari Germans Trias i Pujol Can Ruti

Badalona (Barcelona), 08916, Spain

Location

Hospital Val d'Hebron

Barcelona, 08035, Spain

Location

Duran i Reynals Institut Catala d'Oncologia

Barcelona, 08907, Spain

Location

Hospital Universitario Fundacion Jimenez Diaz

Madrid, 28040, Spain

Location

Hospital 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario de Salamanca

Salamanca, 37007, Spain

Location

Hospital Marques de Valdecilla

Santander, 39008, Spain

Location

Hospital de la Fe

Valencia, 46009, Spain

Location

Related Publications (1)

  • Narla RK, Modi H, Bauer D, Abbasian M, Leisten J, Piccotti JR, Kopytek S, Eckelman BP, Deveraux Q, Timmer J, Zhu D, Wong L, Escoubet L, Raymon HK, Hariharan K. Modulation of CD47-SIRPalpha innate immune checkpoint axis with Fc-function detuned anti-CD47 therapeutic antibody. Cancer Immunol Immunother. 2022 Feb;71(2):473-489. doi: 10.1007/s00262-021-03010-6. Epub 2021 Jul 10.

    PMID: 34247273DERIVED

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

CC-90002Rituximab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Michael Burgess, MD, PhD

    Celgene

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2015

First Posted

February 20, 2015

Study Start

March 12, 2015

Primary Completion

December 24, 2020

Study Completion

December 24, 2020

Last Updated

August 12, 2021

Record last verified: 2021-08

Locations

US(5)ES(8)