Study of CB-103 in Adult Patients With Advanced or Metastatic Solid Tumours and Haematological Malignancies

January 12, 2024 updated by: Cellestia Biotech AG

A Phase I/IIA, Multi-Centre, Open-Label, Dose-Escalation Study With Expansion Arms to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CB-103 Administered Orally in Adult Patients With Locally Advanced or Metastatic Solid Tumours and Haematological Malignancies Characterised by Alterations of the NOTCH Signalling Pathway

This is a phase I/II, non randomized, open-label, dose escalation study to investigate the safety, tolerability and preliminary efficacy of CB-103.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This Phase I/IIA, open label, multicenter, dose escalation study of CB-103 in patients with Locally Advanced or Metastatic Solid Tumours and Haematological Malignancies. After providing signed informed consent, patients will be screened for entry into the study. The study will be conducted in 2 stages: dose escalation in Part A of the study (Phase I) followed by dose expansion in Part B (Phase IIA).

Escalation cohorts will receive repeat doses of CB-103 to determine the MTD and RP2D.

CB-103 will be administered orally in treatment cycles of 28-days each. Aim of the expansion Phase IIA, Part B of the study will be to collect preliminary evidence of anti-tumour activity.

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Phase 2
  • 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 Locations

  • France
      • Lyon, France
        • Centre Hospitalier Lyon-Sud
      • Paris, France, 75475
        • Hôpital Saint-Louis
  • Germany
      • Berlin, Germany, 10117
        • Charite- Universitaetsmedizin Berlin- Campus Benjamin Franklin
      • Frankfurt, Germany, 60590
        • Universitätsklinikum Frankfurt
      • Heidelberg, Germany, 69120
        • Nationales Centrum für Tumorerkrankungen Heidelberg
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital - Yonsei Cancer Center
      • Seoul, Korea, Republic of, 06351
        • Seoul National University Hospital
  • Spain
      • Barcelona, Spain, 08035
        • Vall d'Hebron Institute of Oncology (VHIO)
      • Barcelona, Spain, 08023
        • Hospital Quiron Barcelona
      • Barcelona, Spain, 08916
        • Catalan Institute of Oncology
      • Madrid, Spain, 28034
        • Hospital Ramón y Cajal
  • Switzerland
      • Bellinzona, Switzerland, 6500
        • Oncology Institute of Southern Switzerland
      • Saint Gallen, Switzerland, 9007
        • Kantonsspital St.Gallen
  • United States
    • California
      • Santa Monica, California, United States, 90403
        • Sarcoma Oncology Research Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson

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:

  1. Disease

    • Patients with histologically or cytologically confirmed solid tumours (breast cancer (triple negative breast cancer [TNBC], ER+/-, HER2+/-), gastrointestinal (GI) cancers (resistant to oxaliplatin or irinotecan-based therapy colorectal cancer [CRC]), osteosarcoma, adenoid cystic carcinoma (ACC), and malignant glomus tumour) that are surgically unresectable, locally advanced, or metastatic and whose disease has progressed on at least one line of systemic therapy (with the exception of ACC patients who are allowed to be systemic treatment-naïve) and for whom no established therapeutic alternatives exist. Any other solid cancer (including lymphoma) with a confirmed NOTCH1-4 activating mutation or genetic lesion.
    • Relapsed or refractory (r/r) T-cell acute lymphoblastic leukaemia (T-ALL) or lymphoma (T-LBL) with a confirmed NOTCH pathway activation. Refractory patients are defined as T-ALL/T-LBL patients with ≥ 5% bone marrow blasts, and/or concomitant extramedullary involvement, who have not achieved a CR after standard induction/consolidation therapy attempt.
  2. Demography: men and women ≥ 18 years old
  3. Adequate organ function and laboratory results
  4. Adequate contraceptive measures
  5. Signed informed consent

EXCLUSION CRITERIA

  1. Medical History

    1. Patients with symptomatic CNS metastases (neurologically unstable or requiring increasing doses of steroids to control their CNS disease)
    2. Hypersensitivity to any of the excipients of CB-103
    3. Patients with unresolved nausea, vomiting, or diarrhoea of CTCAE grade > 1
    4. Impairment of GI function or presence of GI disease that may significantly alter the absorption of CB-103

    5. History of second or other primary cancer with the exception of:

      • Curatively treated non-melanomatous skin cancer
      • Curatively treated cervical cancer or breast carcinoma in situ
      • Other primary solid tumour treated with curative intent and no known active disease present and no treatment administered during the last 2 years.
  2. Exclusionary concurrent medical conditions Impaired cardiac function or clinically significant cardiac diseases.

  3. Prior Therapy

    • In patients with solid tumours cytotoxic chemotherapy within 3 weeks
    • In T-ALL/T-LBL patients, prior anticancer therapy less than 2 weeks prior to starting therapy or 5 half-lives (whichever is longer) with exceptions.
    • Radiation therapy within 2 weeks of scheduled CB-103 dosing day 1
    • Immunotherapy, biological therapies, targeted small molecules, hormonal therapies within 3 weeks of scheduled CB-103 dosing day 1
    • Unresolved toxicity CTCAE grade > 1 from previous anti-cancer therapy or radiotherapy (excluding neurotoxicity, alopecia, ototoxicity, lymphopenia), or incomplete recovery from previous surgery.

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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CB-103
CB-103 capsules will be administered orally in treatment cycles of 28-days each.
Drug: CB-103
Hard gelatine capsules taken orally during treatment period. Treatment cycle is 28 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose Limiting Toxicity (DLT)
Time Frame: 28 days

Number of patients with dose limiting toxicity during the first cycle.

DLT is defined as a severe adverse event or abnormal laboratory value assessed as unrelated to disease progression, inter-current illness, or concomitant medications, that occurs ≤ 28 days following the first dose of CB-103 (Cycle 1).
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate
Time Frame: 24 months
Number of patients with an overall response rate (CR+PR assessed by RECSIT v1.1 or CR or CRi by NCCN guidelines) up to 24 months
24 months

Collaborators and Investigators

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

Sponsor

Cellestia Biotech AG

Investigators

  • Principal Investigator: Elena Garalda, MD, PhD, Vall d'Hebron University Hospital

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

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)

December 5, 2017

Primary Completion (Actual)

November 11, 2022

Study Completion (Actual)

November 11, 2022

Study Registration Dates

First Submitted

January 19, 2018

First Submitted That Met QC Criteria

January 30, 2018

First Posted (Actual)

February 6, 2018

Study Record Updates

Last Update Posted (Estimated)

January 15, 2024

Last Update Submitted That Met QC Criteria

January 12, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CB103-C-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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