ClinicalTrials.gg
TerminatedNCT03422679Updated Jan 16, 2024Results posted

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

A Phase 1/2 interventional study of CB-103 in Breast Cancer, Colorectal Cancer and Adenoid Cystic Carcinoma, sponsored by Cellestia Biotech AG. Terminated at 17 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-16.

Sponsored by Cellestia Biotech AG · Phase 1/2, Interventional, and Treatment

Why this study was terminated
business reason

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Phase
Phase 1/2
Study type
Interventional
Enrollment
79
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 905 studies in Breast Neoplasms with a site in Spain — 164 open to participants now, 286 under way, 84 of them phase 3. Breast Neoplasms · Spain.

Enrollment
552nd of 805
79 · median 151
Started
2017
with 39 others
Phase 1/2
70 of 905
17 open now
Registered
456th of 905
by date

Among the 905 studies in Breast Neoplasms with a site in Spain, this one is the 552nd largest by enrollment of the 805 interventional ones that give a count, is one of 40 that started in 2017, is one of 70 in phase 1/2, and was the 456th registered.

Breast Neoplasms

14,829 studies on the registry are indexed under Breast Neoplasms; 3,320 are open to participants now.

Browse Breast Neoplasms studies →

Open to participants now

164 of the 905 studies in Breast Neoplasms with a site in Spain are open now. Recruiting first, the newest first:

159 more — sign in →

All 164 open studies →

A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →

Who these studies take

Of the 2,399 Breast Neoplasms studies recruiting now, 1,570 (65%) set no upper age limit and 592 (25%) stop at 75 or younger; 103 take children under 18; 215 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Breast Cancer
  • Colorectal Cancer
  • Adenoid Cystic Carcinoma
  • Non-hodgkin Lymphoma
  • Glomus Tumor, Malignant
  • Hepatocellular Carcinoma
  • Osteosarcoma
  • T-ALL

Keywords

  • advanced solid tumours
  • haematological malignancies
  • phase I/II
  • NOTCH pathway
  • pan-NOTCH inhibitor
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Disease

    • Patients with or cytologically confirmed solid tumours (breast cancer (triple negative breast cancer [TNBC], ER+/-, +/-), 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 and whose disease has progressed on at least one (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.
    • (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 measures
  5. Signed

Exclusion criteria

EXCLUSION CRITERIA

  1. Medical History

    1. Patients with symptomatic (neurologically unstable or requiring increasing doses of to control their CNS disease)
    2. to any of the of CB-103
    3. Patients with unresolved nausea, vomiting, or diarrhoea of 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 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.
Terms in these criteria, in plain language(13)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

HER2

HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.

In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
79 participants (actual)

Study arms

  • Experimental
    CB-103

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

    Drug: CB-103

Interventions

  • DrugCB-103

    Hard gelatine capsules taken orally during treatment period. Treatment cycle is 28 days.

06

What researchers measure

Primary outcomes

  1. Dose Limiting Toxicity (DLT)

    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).

    Time frame: 28 days

Secondary outcomes

  1. Overall Response Rate

    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

    Time frame: 24 months

07

Results

Posted Jan 16, 2024

Participant flow

Participant flow — Overall Study
MilestoneCohort 1Cohort 2Cohort 3Cohort 4Cohort 5Cohort 6Cohort 7Cohort 8Cohort 9Cohort 10Cohort 11Cohort 12Confirmatory Cohort
Started53773439564815
Completed53773439564815
Not completed0000000000000

Outcome measures

PrimaryDose Limiting Toxicity (DLT)

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).

Time frame:
28 days
Reported as:
Count of participants · Participants
Dose Limiting Toxicity (DLT)
ParticipantsCohort 1Cohort 2Cohort 3Cohort 4Cohort 5Cohort 6Cohort 7Cohort 8Cohort 9Cohort 10Cohort 11Cohort 12Confirmatory Cohort
Dose Limiting Toxicity (DLT)0000000100100
SecondaryOverall Response Rate

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

Time frame:
24 months
Reported as:
Count of participants · Participants
Overall Response Rate
ParticipantsCohort 1Cohort 2Cohort 3Cohort 4Cohort 5Cohort 6Cohort 7Cohort 8Cohort 9Cohort 10Cohort 11Cohort 12Confirmatory Cohort
Overall Response Rate1255212425143

Adverse events

Collected over From Cycle 1 Day 1 through Safety Follow-up (28 days after the last dose of CB-103), up to 24 months. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cohort 10/5 (0%)0/5 (0%)3/5 (60%)
Cohort 20/3 (0%)0/3 (0%)2/3 (66.7%)
Cohort 30/7 (0%)0/7 (0%)5/7 (71.4%)
Cohort 40/7 (0%)1/7 (14.3%)4/7 (57.1%)
Cohort 50/3 (0%)0/3 (0%)2/3 (66.7%)
Cohort 60/4 (0%)0/4 (0%)3/4 (75%)
Cohort 70/3 (0%)0/3 (0%)3/3 (100%)
Cohort 80/9 (0%)0/9 (0%)7/9 (77.8%)
Cohort 90/5 (0%)1/5 (20%)4/5 (80%)
Cohort 100/6 (0%)0/6 (0%)6/6 (100%)
Cohort 110/4 (0%)0/4 (0%)4/4 (100%)
Cohort 120/8 (0%)0/8 (0%)7/8 (87.5%)
Confirmatory Cohort0/15 (0%)1/15 (6.7%)9/15 (60%)
Most frequent serious events
Most frequent serious events
EventCohort 1Cohort 2Cohort 3Cohort 4Cohort 5Cohort 6Cohort 7Cohort 8Cohort 9Cohort 10Cohort 11Cohort 12Confirmatory Cohort
Steven-Johnson SyndromeSkin and subcutaneous tissue disorders0/50/30/70/70/30/40/30/91/50/60/40/80/15
Drug Induced Liver InjuryHepatobiliary disorders0/50/30/71/70/30/40/30/90/50/60/40/80/15
Liver Function Test IncreasedHepatobiliary disorders0/50/30/70/70/30/40/30/90/50/60/40/81/15
Most frequent other events
Most frequent other events
EventCohort 1Cohort 2Cohort 3Cohort 4Cohort 5Cohort 6Cohort 7Cohort 8Cohort 9Cohort 10Cohort 11Cohort 12Confirmatory Cohort
dyschromatopsiaEye disorders0/50/30/70/70/30/40/32/91/55/63/43/81/15
anaemiaBlood and lymphatic system disorders0/50/30/70/70/30/41/31/92/52/62/43/82/15
fatigueGeneral disorders1/51/31/70/70/30/41/31/91/51/62/40/80/15
diarrhoeaGastrointestinal disorders1/50/33/71/70/31/40/32/90/51/60/41/80/15
NauseaGastrointestinal disorders2/51/32/72/70/30/41/32/91/52/60/41/83/15
vision blurredEye disorders0/50/30/71/71/31/40/32/91/52/60/43/81/15
dyspepsiaGastrointestinal disorders0/50/31/70/70/31/40/33/90/52/60/41/82/15
vomitingGastrointestinal disorders0/50/30/70/71/30/40/32/91/52/61/42/82/15

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5Cohort 6Cohort 7Cohort 8Cohort 9Cohort 10Cohort 11Cohort 12Confirmatory CohortTotal
<=18 years00000000000000
Between 18 and 65 years3345332535341255
>=65 years203201142114324
Age, Continuous
Age, Continuous(years)Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5Cohort 6Cohort 7Cohort 8Cohort 9Cohort 10Cohort 11Cohort 12Confirmatory CohortTotal
Mean57.2 (39 to 74)55.7 (39 to 74)52.7 (25 to 67)54.4 (38 to 70)51.3 (44 to 62)54.8 (41 to 69)61.7 (49 to 76)56.6 (28 to 76)64.6 (56 to 75)54 (42 to 72)51.5 (23 to 74)58.6 (25 to 75)46.9 (23 to 71)54.4 (23 to 76)
Sex: Female, Male
Sex: Female, Male(Participants)Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5Cohort 6Cohort 7Cohort 8Cohort 9Cohort 10Cohort 11Cohort 12Confirmatory CohortTotal
Female113332252412534
Male4244021432361045
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5Cohort 6Cohort 7Cohort 8Cohort 9Cohort 10Cohort 11Cohort 12Confirmatory CohortTotal
American Indian or Alaska Native00000000000000
Asian00000000000167
Native Hawaiian or Other Pacific Islander00000000000000
Black or African American00000000100001
White537724394647970
More than one race00000000000000
Unknown or Not Reported00001000000001
Region of Enrollment
Region of Enrollment(participants)Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5Cohort 6Cohort 7Cohort 8Cohort 9Cohort 10Cohort 11Cohort 12Confirmatory CohortTotal
South Korea00000000000099
United States000000001225313
Switzerland123300141000015
Germany00000000012115
Spain414434253302237
08

Study locations

17 sites
  • Sarcoma Oncology Research Center
    Santa Monica, California 90403, United States
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02215, United States
  • MD Anderson
    Houston, Texas 77030, United States
  • Centre Hospitalier Lyon-Sud
    Lyon, France
  • Hôpital Saint-Louis
    Paris, 75475, France
  • Charite- Universitaetsmedizin Berlin- Campus Benjamin Franklin
    Berlin, 10117, Germany
  • Universitätsklinikum Frankfurt
    Frankfurt, 60590, Germany
  • Nationales Centrum für Tumorerkrankungen Heidelberg
    Heidelberg, 69120, Germany
  • Seoul National University Hospital
    Seoul, 03080, Korea, Republic of
  • Severance Hospital - Yonsei Cancer Center
    Seoul, 03722, Korea, Republic of
  • Seoul National University Hospital
    Seoul, 06351, Korea, Republic of
  • Hospital Quirón Barcelona
    Barcelona, 08023, Spain
  • Vall d'Hebron Institute of Oncology (VHIO)
    Barcelona, 08035, Spain
  • Catalan Institute of Oncology
    Barcelona, 08916, Spain
  • Hospital Ramón y Cajal
    Madrid, 28034, Spain
  • Oncology Institute of Southern Switzerland
    Bellinzona, 6500, Switzerland
  • Kantonsspital St.Gallen
    Saint Gallen, 9007, Switzerland
09

References and documents

Publications

  • Hanna GJ, Stathis A, Lopez-Miranda E, Racca F, Quon D, Leyvraz S, Hess D, Keam B, Rodon J, Ahn MJ, Kim HR, Schneeweiss A, Ribera JM, DeAngelo D, Perez Garcia JM, Cortes J, Schonborn-Kellenberger O, Weber D, Pisa P, Bauer M, Beni L, Bobadilla M, Lehal R, Vigolo M, Vogl FD, Garralda E. A Phase I Study of the Pan-Notch Inhibitor CB-103 for Patients with Advanced Adenoid Cystic Carcinoma and Other Tumors. Cancer Res Commun. 2023 Sep 14;3(9):1853-1861. doi: 10.1158/2767-9764.CRC-23-0333. PubMed 37712875 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2017 to primary completion in Nov 2022, 59 months.

Results were first posted in Jan 2024, 1 year 2 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 19, 2018
First posted
Feb 6, 2018
StartActual
Dec 5, 2017
Primary completionActual
Nov 11, 2022
CompletionActual
Nov 11, 2022
Results first posted
Jan 16, 2024
Last update
Jan 16, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03422679
Lead sponsor
Cellestia Biotech AG
Responsible party
Sponsor
First posted
Feb 6, 2018
Start date
Dec 5, 2017
Primary completion
Nov 11, 2022
Completion
Nov 11, 2022
Results posted
Jan 16, 2024
Last update
Jan 16, 2024

Study contacts

Elena Garalda, MD, PhD
principal investigator · Vall d'Hebron University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Limantrafin

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