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Study to Evaluate Maximum Tolerated Dose of Oral CB-03-10 With Dose Expansion Phase, in Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03863145
Recruitment Status : Active, not recruiting
First Posted : March 5, 2019
Last Update Posted : July 5, 2022
Sponsor:
Information provided by (Responsible Party):
Cosmo Pharmaceuticals NV ( Cosmo Technologies Ltd )

Brief Summary:

Subjects will undergo baseline evaluation and an assessment of extent of disease.

Subjects in Part 1 (Dose Escalation) will receive escalating doses of CB-03-10 based on a modified Fibonacci schema using a standard oncology 3+3 study design to define an MTD and a RP2D. Plasma PK samples will be collected at predetermined timepoints for all subjects.

Subjects in Part 2 (Dose Expansion) of the study will receive CB-03-10 at the RP2D determined in the Part 1 of the study. The indications included in each group will be determined at the completion of Part 1 of the study by Safety Review Committee (SRC).

Subjects will be evaluated weekly initially (for 2 cycles in Part 1 and for 1 cycle in Part 2) and every 2 weeks thereafter. Reassessment of disease will be conducted at Week 8 and every 8 weeks thereafter. Subjects with evidence of response (partial or complete) will be re-evaluated at least 4 weeks later for confirmation.


Condition or disease Intervention/treatment Phase
Advanced Refractory Solid Tumors Subjects Considered Likely to Respond to CB-03-10 Drug: CB-03-10 Early Phase 1

Detailed Description:

Subjects will undergo baseline evaluation and an assessment of extent of disease.

Subjects in Part 1 (Dose Escalation) will receive escalating doses of CB-03-10 based on a modified Fibonacci schema using a standard oncology 3+3 study design to define an MTD and a RP2D. Plasma PK samples will be collected at predetermined timepoints for all subjects.

Subjects in Part 2 (Dose Expansion) of the study will receive CB-03-10 at the RP2D determined in the Part 1 of the study. The indications included in each group will be determined at the completion of Part 1 of the study by Safety Review Committee (SRC).

Subjects will be evaluated weekly initially (for 2 cycles in Part 1 and for 1 cycle in Part 2) and every 2 weeks thereafter. Reassessment of disease will be conducted at Week 8 and every 8 weeks thereafter. Subjects with evidence of response (partial or complete) will be re-evaluated at least 4 weeks later for confirmation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Intervention Model Description: Part 1 (Dose Escalation): Subjects with advanced refractory solid tumors Part 2 (Dose Expansion): Defined subject subgroups considered likely to respond to CB-03-10 (eg, relapsed/refractory pancreatic adenocarcinoma, androgen independent prostate adenocarcinoma, triple-negative breast adenocarcinoma) or indications that demonstrated activity in Part 1
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label, Multicenter, Phase 1 Study to Evaluate the Maximum Tolerated Dose of Orally Administered CB-03-10 With Dose Expansion Phase, in Subjects With Advanced Solid Tumors
Actual Study Start Date : June 14, 2022
Estimated Primary Completion Date : January 1, 2026
Estimated Study Completion Date : June 1, 2026

Arm Intervention/treatment
Experimental: 1
Part 1 (Dose Escalation): 100 mg daily.
Drug: CB-03-10
CB-03-10, 100 mg capsule for oral use




Primary Outcome Measures :
  1. Determine the maximum tolerated dose [ Time Frame: 29 days ]
    Determine the maximum tolerated dose (MTD) of CB-03-10 in subjects with advanced solid tumors

  2. Determine the dose-limiting toxicity [ Time Frame: 28 days ]
    Determine the dose-limiting toxicity (DLT) of CB-03-10 in subjects with advanced solid tumors


Secondary Outcome Measures :
  1. Determine a recommended Phase 2 dose (RP2D) of CB-03-10 [ Time Frame: 28 days ]
    Determine a recommended Phase 2 dose (RP2D) of CB-03-10



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

Signed informed consent For Part 1 (Dose Escalation): Histologically or cytologically confirmed relapsed or refractory locally advanced or metastatic solid tumor, not amenable to standard therapy For Part 2 (Dose Expansion): Histologically or cytologically confirmed relapsed or refractory locally advanced or metastatic solid tumor limited to a specific tumor subtype as determined by the SRC Age >18 years Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 For Part 1 (Dose Escalation): Measurable or evaluable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria For Part 2 (Dose Expansion): Measurable disease as per RECIST v1.1 criteria. Adequate renal, hepatic and bone marrow function as defined by Screening labs Negative pregnancy test for females of childbearing potential at the Screening Visit and use of appropriate method of birth control.

EXCLUSION CRITERIA Pregnant or breastfeeding women Known central nervous system (CNS) metastases or spinal cord compression Known second cancer of other primary origin (excluding Stage I non-melanoma skin cancer and prostate cancer controlled with hormonal therapy) within the prior 5 years Active autoimmune disease Significant cardiac disease Uncontrolled hypertension Major surgery or irradiation within 28 days prior to start of study treatment Fewer than 28 days (or fewer than 5 half-lives, whichever is shorter) from prior anticancer therapy Requirement for chronic corticosteroids or other immunosuppressant drugs Known infection with hepatitis B or C virus Known infection with HIV and CD4+ T-cell counts < 350 cells/uL Patients with an opportunistic infection within the past 12 months.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03863145


Locations
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United States, California
University of California Irvine Health Chao Family Comprehensive Cancer Center
California City, California, United States, 92868
United States, Colorado
University of Colorado Cancer Center
Colorado Springs, Colorado, United States, 80045
United States, Connecticut
Yale Cancer Center
New Haven, Connecticut, United States, 208028
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Michigan Center, Michigan, United States, 48201
United States, Ohio
Gabrail Cancer Center
Ohio City, Ohio, United States, 44718
United States, Texas
Tranquil Clinical Research
Texas City, Texas, United States, 77598
Sponsors and Collaborators
Cosmo Technologies Ltd
Additional Information:
Publications of Results:
Stringer EM, Saha P, Swoboda A, Kocherginsky M, Baker G, Olberkyte S, et al. A phase I trial of mifepristone (M), carboplatin (C), and gemcitabine (G) in advanced breast and ovarian cancer. J Clin Oncol. 2017;35 (15 sup(1083):1083.

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Responsible Party: Cosmo Technologies Ltd
ClinicalTrials.gov Identifier: NCT03863145    
Other Study ID Numbers: CB-03-10/01
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: July 5, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms