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Hematologic NeoplasmsPhase 1NCT02367196

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

A Phase 1 study testing CC-90002 and Rituximab in people with Hematologic Neoplasms, run by Celgene at 13 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Hematologic Neoplasms
What is being tested?
CC-90002 and Rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
13 sitesin 2 countries
Study dates
12 Mar 2015to 24 Dec 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
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  • 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.
  • concurrent second cancers requiring active, ongoing systemic treatment.

Trial locations and contacts

13 sites in 2 countries.

13 sites in 2 countries

Spain8 sites

  • Hospital Universitari Germans Trias i Pujol Can Ruti

    Badalona (Barcelona), 08916

  • Hospital Val d'Hebron

    Barcelona, 08035

  • Duran i Reynals Institut Catala d'Oncologia

    Barcelona, 08907

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital 12 de Octubre

    Madrid, 28041

  • Hospital Universitario de Salamanca

    Salamanca, 37007

  • Hospital Marques de Valdecilla

    Santander, 39008

  • Hospital de la Fe

    Valencia, 46009

Other trials in Spain

United States5 sites

  • Yale University School of Medicine

    New Haven, Connecticut, 06520-8073

  • South Texas Accelerated Research Therapeutics

    San Antonio, Texas, 78229

  • University of California San Francisco

    San Francisco, California, 94143-1270

  • Scottsdale Healthcare Research Institute

    Scottsdale, Arizona, 85258

  • University of Arizona Cancer Center

    Tucson, Arizona, 85724

Other trials in United States

About this study

Official title: 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

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

Read the 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.

Being tested
CC-90002, Rituximab
Keywords
CC-90002, Monoclonal, Antibody, CD47, Advanced, Solid Cancers, Hematologic Cancers
Medical subject headings
Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02367196
Study groupRoleWhat they receive
Part A: CC-90002ExperimentalCC-90002 will be given by intravenous (IV) infusion on a 28 day cycle
Receives: Drug: CC-90002
Part B: CC-90002 with RituximabExperimentalCC-90002 in combination with Rituximab will be given by intravenous (IV) infusion on a 28 day cycle in subjects with CD20-positive NHL
Receives: Drug: CC-90002; Drug: Rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-Limiting Toxicity (DLT)

    Number of participants with a DLT

    Measured: Up to 18 months

  2. 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.

    Measured: Up to 18 months

  3. 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.

    Measured: Up to 18 months

  4. 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.

    Measured: Up to 24 months

  5. 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.

    Measured: Up to 24 months

Secondary outcomes (10)

  1. Antitumor efficacy

    Determined by response rates of each tumor type using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and other tumor-appropriate response criteria.

    Measured: Up to 36 months

  2. Pharmacokinetics - Cmax

    Maximum observed concentration in serum

    Measured: Cycle 1 and beyond; and after discontinuation

  3. Pharmacokinetics - AUC

    Area under the serum concentration - time curve

    Measured: Cycle 1 and beyond; and after discontinuation

  4. Pharmacokinetics - tmax

    Time to peak (maximum) serum concentration

    Measured: Cycle 1 and beyond; and after discontinuation

  5. Pharmacokinetics - T1/2

    Terminal half-life (T1/2)

    Measured: Cycle 1 and beyond; and after discontinuation

  6. Pharmacokinetics - CL

    Total body clearance of the drug from serum

    Measured: Cycle 1 and beyond; and after discontinuation

  7. Pharmacokinetics - Vmax

    Volume of distribution at steady-state

    Measured: Cycle 1 and beyond; and after discontinuation

  8. Anti-Drug Antibodies (ADAs)

    Determine the presence and frequency of anti-drug antibodies

    Measured: Cycle 1 and beyond; and after discontinuation

  9. Overall Survival - Part B

    Measured as the time from the first dose of CC-90002 to death due to any cause.

    Measured: Up to 2 years

  10. Progression-free survival- Part B

    Defined as the time from the first dose of CC-90002 to the first occurrence of disease progression or death from any cause

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2015 (estimated)
  2. Study start12 Mar 2015
  3. Primary completion24 Dec 2020
  4. Study completion24 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02367196
Sponsor's protocol ID
CC-90002-ST-001
Other IDs
2015-000101-39, 2015
Status last verified
Aug 2021
First submitted
13 Feb 2015
Last updated
12 Aug 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 34247273

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CC-90002 and Rituximab in people with Hematologic Neoplasms, run by Celgene at 13 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Spain, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-Limiting Toxicity (DLT) (time frame: Up to 18 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02367196, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2021.

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