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Study of CBX-12 in Subjects With Advanced or Metastatic Refractory Solid Tumors

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ClinicalTrials.gov Identifier: NCT04902872
Recruitment Status : Recruiting
First Posted : May 26, 2021
Last Update Posted : May 28, 2021
Sponsor:
Information provided by (Responsible Party):
Cybrexa Therapeutics

Brief Summary:
This is a first-in-human, Phase 1/2 open-label, multicenter, dose-escalation, safety, pharmacokinetics (PK), and biomarker study of CBX-12 in subjects with advanced or metastatic refractory solid tumors.

Condition or disease Intervention/treatment Phase
Solid Tumor, Adult Epithelial Ovarian Cancer Small Cell Lung Carcinoma Drug: CBX-12 Phase 1 Phase 2

Detailed Description:

Phase 1 is the dose-escalation portion of the study in which the safety and tolerability of two dosing schedules of CBX-12 will be evaluated. Subjects in Part A will be treated with CBX-12 on a daily x 5 every 3 weeks schedule. Subjects in Phase 1 Part B will be treated with CBX-12 on a daily x 3 every 3 weeks schedule. Once at least 2 cohorts in Part A have been evaluated for safety through the dose-limiting toxicity (DLT) period and the Safety Review Committee (SRC) has reviewed the safety and available PK data for the completed Part A cohorts, the first cohort in Part B may open for accrual. The initial dose in Part B will be determined based on the safety and tolerability of Part A subjects to that point.

Once the recommended phase 2 dose (RP2D) has been established in both Part A and Part B, Phase 2 expansion cohorts may open.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

Dose Escalation Part A: Single-subject cohorts will be enrolled initially, followed by a 3+3 design.

Dose Escalation Part B: After at least 2 cohorts in Part A have been cleared by the Safety Review Committee (SRC), subjects will be enrolled in Part B using a 3+3 design.

Cohort Expansion: Once the RP2D has been established in Part A and Part B, 2 expansion cohorts will be enrolled.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study of CBX-12 in Subjects With Advanced or Metastatic Refractory Solid Tumors
Actual Study Start Date : May 3, 2021
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : April 2024


Arm Intervention/treatment
Experimental: Phase 1 Dose Escalation (Daily Dosing x 5)
CBX-12 administered on a daily x 5 every 3 weeks schedule
Drug: CBX-12
CBX-12 is an alphalex construct which consists of a low-pH insertion peptide, a self-immolating linker, and exatecan as the pharmacologically active moiety

Experimental: Phase 1 Dose Escalation (Daily Dosing x 3)
CBX-12 administered on a daily x 5 every 3 weeks schedule
Drug: CBX-12
CBX-12 is an alphalex construct which consists of a low-pH insertion peptide, a self-immolating linker, and exatecan as the pharmacologically active moiety

Experimental: Phase 2 Ovarian Cancer Expansion Cohort
CBX-12 administered on a daily x 5 every 3 weeks or on a daily x 3 every 3 weeks schedule
Drug: CBX-12
CBX-12 is an alphalex construct which consists of a low-pH insertion peptide, a self-immolating linker, and exatecan as the pharmacologically active moiety

Experimental: Phase 2 Small Cell Lung Cancer Expansion Cohort
CBX-12 administered on a daily x 5 every 3 weeks or on a daily x 3 every 3 weeks schedule
Drug: CBX-12
CBX-12 is an alphalex construct which consists of a low-pH insertion peptide, a self-immolating linker, and exatecan as the pharmacologically active moiety




Primary Outcome Measures :
  1. Phase 1: Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Through the end of study, estimated as 6 months ]
  2. Phase 1: Recommended Phase 2 Dose for Daily x 5 every 3 weeks schedule of CBX-12 [ Time Frame: 15 months ]
  3. Phase 1: Recommended Phase 2 Dose for Daily x 3 every 3 weeks schedule of CBX-12 [ Time Frame: 15 months ]
  4. Phase 2: Overall response rate (ORR) [ Time Frame: Through the end of study, estimated as 6 months ]
    Based on RECIST v1.1


Secondary Outcome Measures :
  1. Maximum concentration of CBX-12 [ Time Frame: 5 days ]
  2. Area under the curve from 0-24 hours of CBX-12 [ Time Frame: 5 days ]
  3. Time to maximum concentration of CBX-12 [ Time Frame: 5 days ]
  4. Half-life of CBX-12 [ Time Frame: 5 days ]
  5. Clearance (CL) of CBX-12 [ Time Frame: 5 days ]
  6. Apparent Volume of Distribution at Steady State (Vss) CBX-12 [ Time Frame: 5 days ]
  7. Phase 1: ORR [ Time Frame: Through the end of study, estimated as 6 months ]
    Based on RECIST v1.1

  8. Duration of Response (DoR) [ Time Frame: Through the end of study, estimated as 6 months ]
    Based on RECIST v1.1

  9. Progression-free Survival (PFS) [ Time Frame: Through the end of study, estimated as 6 months ]
    Based on RECIST v1.1

  10. Phase 2: Incidence of TEAEs [ Time Frame: Through the end of study, estimated as 6 months ]


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

Key Inclusion Criteria:

  • Subject has a histologically- or cytologically-diagnosed solid tumor which is advanced or metastatic and which has progressed on or following at least one systemic therapy regimen administered for advanced or metastatic disease or for which no approved therapy exists. Subject's prior treatment should include all approved regimens that have demonstrated a survival advantage for the subject's disease, stage, and line of therapy.
  • Has measurable disease per RECIST 1.1.
  • An adequate tumor sample must be available from core needle biopsies obtained during the Screening Period and following the subject's most recent systemic therapy.
  • Agrees to an on-treatment biopsy preferably of the same lesion from which the pre-CBX-12 treatment sample was obtained as long as the Investigator determines such biopsy can be performed with acceptable safety.

Exclusion Criteria:

  • Cytotoxic chemotherapy, biologic agent, investigational agent, or radiation therapy less than or equal to 3 weeks prior to the first dose of CBX-12. The interval may be reduced to 2 weeks for bone only radiation therapy or investigational agents not expected to be associated with adverse events (AEs) after 2 weeks of last administration, with Medical Monitor approval.
  • Small-molecule kinase inhibitors or hormonal agents less than or equal to 14 days prior to the first dose of CBX-12.
  • Subjects who are currently receiving any other anti cancer or investigational agent(s).
  • Clinically significant intercurrent disease.
  • Subjects with primary central nervous system (CNS) tumors or clinically active CNS metastases or carcinomatous meningitis. Subjects with stable brain metastasis may be enrolled with Medical Monitor approval.

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): NCT04902872


Contacts
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Contact: Project Manager 860-501-3027 clinicalstudies@cybrexa.com

Locations
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United States, Texas
NEXT Oncology Recruiting
San Antonio, Texas, United States, 78229
Contact: Cynthia De Leon    210-580-9521    cdeleon@nextoncology.com   
Principal Investigator: Anthony Tolcher, MD         
Sponsors and Collaborators
Cybrexa Therapeutics
Investigators
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Study Director: Chief Medical Officer Cybrexa Therapeutics
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Responsible Party: Cybrexa Therapeutics
ClinicalTrials.gov Identifier: NCT04902872    
Other Study ID Numbers: CBX-12-101
First Posted: May 26, 2021    Key Record Dates
Last Update Posted: May 28, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cybrexa Therapeutics:
SCLC
small cell lung cancer
ovarian
Additional relevant MeSH terms:
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Carcinoma, Ovarian Epithelial
Small Cell Lung Carcinoma
Neoplasms
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Bronchogenic
Bronchial Neoplasms