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

Hematologic Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02367196
• Other study ID #: CC-90002-ST-001
• Secondary ID: 2015-000101-39
• Status: Completed
• Phase: Phase 1
• Start date: March 12, 2015
• Est. completion date: December 24, 2020

Study information

• Verified date: August 2021
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 24, 2020
• Est. primary completion date: December 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

11. Known HIV infection.

12. Known chronic, active hepatitis B or C (HBV/HCV) infection.

13. Ongoing treatment with chronic, therapeutic dosing of anti-coagulants.

14. History of autoimmune hemolytic anemia or autoimmune thrombocytopenia.

15. History of concurrent second cancers requiring active, ongoing systemic treatment.

concurrent second cancers requiring active, ongoing systemic treatment.

Related Conditions & MeSH terms

• Hematologic Neoplasms

Intervention

Drug:
• CC-90002

• Rituximab

Locations

Country	Name	City	State
Spain	Hospital Universitari Germans Trias i Pujol Can Ruti	Badalona (Barcelona)
Spain	Duran i Reynals Institut Catala d'Oncologia	Barcelona
Spain	Hospital Val d'Hebron	Barcelona
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital Universitario Fundacion Jimenez Diaz	Madrid
Spain	Hospital Universitario de Salamanca	Salamanca
Spain	Hospital Marques de Valdecilla	Santander
Spain	Hospital de la Fe	Valencia
United States	Yale University School of Medicine	New Haven	Connecticut
United States	South Texas Accelerated Research Therapeutics	San Antonio	Texas
United States	University of California San Francisco	San Francisco	California
United States	Scottsdale Healthcare Research Institute	Scottsdale	Arizona
United States	University of Arizona Cancer Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Countries where clinical trial is conducted

United States,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-Limiting Toxicity (DLT)	Number of participants with a DLT	Up to 18 months
Primary	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
Primary	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
Primary	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
Primary	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	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.	Up to 36 months
Secondary	Pharmacokinetics - Cmax	Maximum observed concentration in serum	Cycle 1 and beyond; and after discontinuation
Secondary	Pharmacokinetics - AUC	Area under the serum concentration - time curve	Cycle 1 and beyond; and after discontinuation
Secondary	Pharmacokinetics - tmax	Time to peak (maximum) serum concentration	Cycle 1 and beyond; and after discontinuation
Secondary	Pharmacokinetics - T1/2	Terminal half-life (T1/2)	Cycle 1 and beyond; and after discontinuation
Secondary	Pharmacokinetics - CL	Total body clearance of the drug from serum	Cycle 1 and beyond; and after discontinuation
Secondary	Pharmacokinetics - Vmax	Volume of distribution at steady-state	Cycle 1 and beyond; and after discontinuation
Secondary	Anti-Drug Antibodies (ADAs)	Determine the presence and frequency of anti-drug antibodies	Cycle 1 and beyond; and after discontinuation
Secondary	Overall Survival - Part B	Measured as the time from the first dose of CC-90002 to death due to any cause.	Up to 2 years
Secondary	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	Up to 2 years