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

February 6, 2024 updated by: Cosmo Technologies Ltd

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • California City, California, United States, 92868
        • Recruiting
        • University of California Irvine Health Chao Family Comprehensive Cancer Center
        • Contact:
          • Farshid Dayyani
    • Colorado
      • Colorado Springs, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Cancer Center
        • Contact:
          • Jennifer Diamond
    • Connecticut
      • New Haven, Connecticut, United States, 208028
        • Recruiting
        • Yale Cancer Center
        • Contact:
          • Joseph Kim
    • Michigan
      • Michigan Center, Michigan, United States, 48201
        • Recruiting
        • Barbara Ann Karmanos Cancer Institute
        • Contact:
          • Ira Winer
    • Ohio
      • Ohio City, Ohio, United States, 44718
        • Recruiting
        • Gabrail Cancer Center
        • Contact:
          • Gabrail Nashat
    • Texas
      • Texas City, Texas, United States, 77598
        • Recruiting
        • Tranquil Clinical Research
        • Contact:
          • John Knecht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
29 days
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
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cosmo Technologies Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2022

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

March 1, 2019

First Submitted That Met QC Criteria

March 4, 2019

First Posted (Actual)

March 5, 2019

Study Record Updates

Last Update Posted (Estimated)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CB-03-10/01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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