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

NCT03863145 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: CB-03-10/01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 6

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.

Conditions

Advanced Refractory Solid Tumors; Subjects Considered Likely to Respond to CB-03-10

Outcome Measures

Primary Outcomes (2)

• Determine the maximum tolerated dose

  Determine the maximum tolerated dose (MTD) of CB-03-10 in subjects with advanced solid tumors

  29 days

• Determine the dose-limiting toxicity

  Determine the dose-limiting toxicity (DLT) of CB-03-10 in subjects with advanced solid tumors

  28 days

Secondary Outcomes (1)

• Determine a recommended Phase 2 dose (RP2D) of CB-03-10

  28 days

Study Arms (1)

1

EXPERIMENTAL

Part 1 (Dose Escalation): 100 mg daily.

Drug: CB-03-10

Interventions

CB-03-10 DRUG

CB-03-10, 100 mg capsule for oral use

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Cosmo Technologies Ltd: lead

Study Sites (6)

University of California Irvine Health Chao Family Comprehensive Cancer Center

California City, California, 92868, United States

RECRUITING

University of Colorado Cancer Center

Colorado Springs, Colorado, 80045, United States

RECRUITING

Yale Cancer Center

New Haven, Connecticut, 208028, United States

RECRUITING

Barbara Ann Karmanos Cancer Institute

Michigan Center, Michigan, 48201, United States

RECRUITING

Gabrail Cancer Center

Ohio City, Ohio, 44718, United States

RECRUITING

Tranquil Clinical Research

Texas City, Texas, 77598, United States

RECRUITING

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  RESULT

Related Links

• National Cancer Institute. Cancer of the Esophagus - SEER Stat Fact Sheets \[Internet\]. Cancer Statistics. 2015 \[cited 2015 Sep 15\].
• International Council on Harmonisation. Addendum to ICH E11: Clinical Investigation of Medicinal Products in the Pediatric Population e11(r1). Vol. Step 4, ICH Harmonised Guideline E11 (R1). 2017.
• International Conference on Harmonization Guidance on Good Clinical Practice \[Internet\]. \[cited 2016 Jan 1\].

Central Study Contacts

Cristina Banyai

CONTACT

+353867015703; cbanyai@cosmopharma.com

Mara Gerloni

CONTACT

+1 858 4524313; mgerloni@cosmopharma.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 1, 2019
• First Posted: March 5, 2019
• Study Start: June 14, 2022
• Primary Completion: January 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

US (6)