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

• Register: ClinicalTrials.gov
• Last refreshed on: 22 January 2024
• Main ID: NCT03422679
• Date of registration: 19/01/2018
• Prospective Registration: No
• Primary sponsor: Cellestia Biotech AG
• Public title: Study of CB-103 in Adult Patients With Advanced or Metastatic Solid Tumours and Haematological Malignancies
• Scientific title: 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
• Date of first enrolment: December 5, 2017
• Target sample size: 79
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/ct2/show/NCT03422679
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

France, Germany, Korea, Republic of, Netherlands, Spain, Switzerland, United States

Contacts

• Name: Elena Garalda, MD, PhD
• Affiliation: Vall d'Hebron University Hospital

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Adenoid Cystic Carcinoma

Glomus Tumor, Malignant

Osteosarcoma

Colorectal Cancer

Non-hodgkin Lymphoma

Breast Cancer

Hepatocellular Carcinoma

T-ALL

Intervention(s)

Drug: CB-103

Primary Outcome(s)

Dose Limiting Toxicity (DLT) [Time Frame: 28 days]

Secondary Outcome(s)

Overall Response Rate [Time Frame: 24 months]

Secondary ID(s)

CB103-C-101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 16/01/2024
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03422679