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

Phase 1

Terminated

• Conditions: Non-hodgkin Lymphoma; Hepatocellular Carcinoma; Breast Cancer; Adenoid Cystic Carcinoma; Osteosarcoma; Colorectal Cancer; Glomus Tumor, Malignant; T-ALL
• Interventions: Drug: CB-103

• Registration Number: NCT03422679
• Lead Sponsor: Cellestia Biotech AG

Brief Summary

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

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 Timeline

• Study Start: 2017-12-05
• Study First Submitted: 2018-01-19
• Study First Submitted QC: 2018-01-30
• Study First Posted: 2018-02-06
• Primary Completion: 2022-11-11
• Study Completion: 2022-11-11
• Results First Submitted: 2023-10-23
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-12
• Last Update Submitted: 2024-01-12
• Results First Posted: 2024-01-16
• Last Update Posted: 2024-01-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CB-103	CB-103	CB-103 capsules will be administered orally in treatment cycles of 28-days each.

Primary Outcome Measures

Name	Time	Method
Dose Limiting Toxicity (DLT)	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).

Secondary Outcome Measures

Name	Time	Method
Overall Response Rate	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

Trial Locations

Locations (16)

Oncology Institute of Southern Switzerland; 🇨🇭 Bellinzona, Switzerland

Vall d'Hebron Institute of Oncology (VHIO); 🇪🇸 Barcelona, Spain

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Hospital Ramón y Cajal; 🇪🇸 Madrid, Spain

Catalan Institute of Oncology; 🇪🇸 Barcelona, Spain

Hôpital Saint-Louis; 🇫🇷 Paris, France

Hospital Quirón Barcelona; 🇪🇸 Barcelona, Spain

MD Anderson; 🇺🇸 Houston, Texas, United States

Sarcoma Oncology Research Center; 🇺🇸 Santa Monica, California, United States

Centre Hospitalier Lyon-Sud; 🇫🇷 Lyon, France

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Universitätsklinikum Frankfurt; 🇩🇪 Frankfurt, Germany

Charite- Universitaetsmedizin Berlin- Campus Benjamin Franklin; 🇩🇪 Berlin, Germany

Kantonsspital St.Gallen; 🇨🇭 Saint Gallen, Switzerland

Nationales Centrum für Tumorerkrankungen Heidelberg; 🇩🇪 Heidelberg, Germany

Severance Hospital - Yonsei Cancer Center; 🇰🇷 Seoul, Korea, Republic of