BRAF V600 Colorectal CancerPhase 1NCT04294160
A Study of Select Drug Combinations in Adult Patients With Advanced/Metastatic BRAF V600 Colorectal Cancer
A Phase 1 study testing Dabrafenib, LTT462 and Trametinib in people with BRAF V600 Colorectal Cancer, run by Novartis Pharmaceuticals at 18 sites in 10 countries.
Trial summary
A phase Ib, open-label platform study of select drug combinations chosen in order to characterize safety and tolerability of each treatment arm tested and to identify recommended doses and regimens for future studies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- BRAF V600 Colorectal Cancer
- What is being tested?
- Dabrafenib, LTT462 and Trametinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 18 sitesin 10 countries
- Study dates
- 22 Jul 2020to 25 Sep 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution's guidelines. Patients must be willing to undergo a new tumor biopsy at baseline and during on study therapy. Exceptions may be considered after documented discussion with Novartis.
- All patients must have a BRAF V600 mutation confirmed by local assessment.
- Patients with unresectable advanced/metastatic BRAF V600 cancer of the colon or rectum with measurable disease as determined by RECIST v1.1
- Patients must have documented disease progression following, or are intolerant to, 1 or 2 lines of chemotherapy for advanced/metastatic disease
Who cannot join
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in-situ cervical cancer, or other tumors that will not affect life expectancy
- Impairment of gastrointestinal function or gastrointestinal disease that may signficantly alter the absorption of study drugs
- History of or current evidence/risk of retinal verin occlusion or serous retinopathy
- History of or current interstitial lung disease or non-infectious pneumonitis
- Patients with a known history of testing positive for HIV
- Clinically significant cardiac disease at screening
Show all 9Show fewer
- Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
- Pregnant or lactating women
- Other protocol-defined inclusion/exclusion may apply.
Trial locations and contacts
18 sites in 10 countries.
18 sites in 10 countries
United States4 sites
Massachusetts General Hospital Massachusetts General Hospital
Boston, Massachusetts, 02114
Uni Of TX MD Anderson Cancer Cntr
Houston, Texas, 77030
University of California LA Santa Monica Location
Los Angeles, California, 90095
Sarah Cannon Research Institute SC
Nashville, Tennessee, 37203
Germany3 sites
Novartis Investigative Site
Dresden, 01307
Novartis Investigative Site
Essen, 45147
Novartis Investigative Site
Ulm, 89081
Spain3 sites
Novartis Investigative Site
Barcelona, Catalonia, 08035
Novartis Investigative Site
Madrid, 28009
Novartis Investigative Site
Valencia, Valencia, 46010
Belgium2 sites
Novartis Investigative Site
Brussels, 1000
Novartis Investigative Site
Leuven, 3000
About this study
Official title: A Phase Ib, Multicenter, Open-label Dose Escalation and Expansion Platform Study of Select Drug Combinations in Adult Patients With Advanced or Metastatic BRAF V600 Colorectal Cancer
A phase Ib, open-label platform study of select drug combinations chosen in order to characterize safety and tolerability of each treatment arm tested and to identify recommended doses and regimens for future studies.
Read the detailed description
This is a phase Ib, multi-center, open-label study with multiple treatment arms in adult patients with advanced or metastatic BRAF V600 (E, D, or K) in order to characterize safety and tolerability of each treatment arm tested and to identify recommended doses and regimens for future studies. The open platform design of this study is adaptive to allow removal of combination treatment arm(s) based on emerging data and facilitate introduction of new candidate combinations. The study is comprised of a dose escalation part and may be followed by a dose expansion part for any combination treatment arm.
- Conditions
- BRAF V600 Colorectal Cancer
- Being tested
- Dabrafenib, LTT462, Trametinib, LXH254, TNO155
- Keywords
- Phase Ib, BRAF-mutated, BRAF V600E, BRAF V600D, BRAF V600K, colorectal cancer, colon cancer, rectal cancer, metastatic, BLRM with EWOC
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DabrafenibDrug
Also called DRB436, Tafinlar
Capsule for oral use
LTT462Drug
Capsule for oral use
TrametinibDrug
Also called TMT212, Mekinist
Tablet for oral use
LXH254Drug
Tablet for oral use
TNO155Drug
Capsule for oral use
SpartalizumabBiological
Also called PDR001
Liquid in vial (Concentrate for solution for infusion) for intravenous use
TislelizumabBiological
Also called VDT482, BGBA317
Liquid in vial (Concentrate for solution for infusion) for intravenous use
| Study group | Role | What they receive |
|---|---|---|
| Dabrafenib + LTT462 backbone arm 1 | Experimental | dose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer Receives: Drug: Dabrafenib; Drug: LTT462 |
| Dabrafenib + LTT462 + trametinib triplet arm 1 | Experimental | dose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer Receives: Drug: Dabrafenib; Drug: LTT462; Drug: Trametinib |
| Dabrafenib + LTT462 + LXH254 triplet arm 2 | Experimental | dose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer - Arm is closed for further enrollment. Receives: Drug: Dabrafenib; Drug: LTT462; Drug: LXH254 |
| Dabrafenib + LTT462 + TNO155 triplet arm 3 | Experimental | dose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer Receives: Drug: Dabrafenib; Drug: LTT462; Drug: TNO155 |
| Dabrafenib + LTT462 + spartalizumab triplet arm 4 | Experimental | dose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer - Arm is closed for further enrollment. Receives: Drug: Dabrafenib; Drug: LTT462; Biological: Spartalizumab |
| Dabrafenib + trametinib + TNO155 triplet arm 5 | Experimental | dose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer Receives: Drug: Dabrafenib; Drug: Trametinib; Drug: TNO155 |
| Dabrafenib + LTT462 + Tislelizumab triplet arm 6 | Experimental | dose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer Receives: Drug: Dabrafenib; Drug: LTT462; Biological: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and nature of dose limiting toxicities (DLTs) in the first cycle
To characterize safety and tolerability of each treatment arm tested and identify recommended doses (RD) and regimens for future studies
Measured: 30 months
Incidence and severity of AEs and SAEs, including changes in laboratory values, vital signs, and ECGs
To characterize safety and tolerability of each treatment arm tested and identify recommended doses and regimens for future studies
Measured: 34 months
Frequency of dose interruptions
To characterize safety and tolerability of each treatment arm tested and identify recommended doses and regimens for future studies
Measured: 30 months
Frequency of dose reductions
To characterize safety and tolerability of each treatment arm tested and identify recommended doses and regimens for future studies
Measured: 30 months
Dose intensity
To characterize safety and tolerability of each treatment arm tested and identify recommended doses and regimens for future studies
Measured: 30 months
Secondary outcomes (10)
AUClast derived from Serum/plasma concentration of individual investigational drugs within combination treatments
To characterize the PK of each investigational drug within each treatment arm
Measured: 30 months
Best overall response (BOR)
To evaluate preliminary anti-tumor activity of each treatment arm per RECIST v1.1.
Measured: 34 months
Progression free survival (PFS)
To evaluate preliminary anti-tumor activity of each treatment arm per RECIST v1.1.
Measured: 34 months
Overall response rate (ORR)
To evaluate preliminary anti-tumor activity of each treatment arm per RECIST v1.1.
Measured: 34 months
Duration of response (DOR)
To evaluate preliminary anti-tumor activity of each treatment arm per RECIST v1.1.
Measured: 34 months
Disease control rate (DCR)
To evaluate preliminary anti-tumor activity of each treatment arm per RECIST v1.1.
Measured: 34 months
Change from baseline of the PD marker DUSP6 in tumor tissue (dose escalation only)
To evaluate PD effect in their respective combinations in tumor
Measured: 30 months
AUCtau derived from Serum/plasma concentration of individual investigational drugs within combination treatments
To characterize the PK of each investigational drug within each treatment arm
Measured: 30 months
Cmax derived from Serum/plasma concentration of individual investigational drugs within combination treatments
To characterize the PK of each investigational drug within each treatment arm
Measured: 30 months
Tmax derived from Serum/plasma concentration of individual investigational drugs within combination treatments
To characterize the PK of each investigational drug within each treatment arm
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start22 Jul 2020
- Primary completion25 Sep 2024
- Study completion25 Sep 2024
Why it stopped: The decision of early termination was made due to business reasons, and was not based on any safety concerns for any of the treatment combinations.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BRAF V600 Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04294160
- Sponsor's protocol ID
- CADPT01C12101
- Status last verified
- Dec 2025
- First submitted
- 2 Mar 2020
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Multicenter, Open-label Dose Escalation and Expansion Platform Study of Select Drug Combinations in Adult Patients With Advanced or Metastatic BRAF V600 Colorectal Cancer
- ClinicalTrials.gov ID
- NCT04294160
- Acronym / sponsor ID
- CADPT01C12101
- Conditions
- BRAF V600 Colorectal Cancer
- Keywords
- Phase Ib, BRAF-mutated, BRAF V600E, BRAF V600D, BRAF V600K, colorectal cancer, colon cancer, rectal cancer, metastatic, BLRM with EWOC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The decision of early termination was made due to business reasons, and was not based on any safety concerns for any of the treatment combinations.
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2020 (actual)
- Primary completion
- 25 Sep 2024 (actual)
- Study completion
- 25 Sep 2024 (actual)
- First posted
- 3 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase Ib, open-label platform study of select drug combinations chosen in order to characterize safety and tolerability of each treatment arm tested and to identify recommended doses and regimens for future studies.
Detailed description
This is a phase Ib, multi-center, open-label study with multiple treatment arms in adult patients with advanced or metastatic BRAF V600 (E, D, or K) in order to characterize safety and tolerability of each treatment arm tested and to identify recommended doses and regimens for future studies. The open platform design of this study is adaptive to allow removal of combination treatment arm(s) based on emerging data and facilitate introduction of new candidate combinations. The study is comprised of a dose escalation part and may be followed by a dose expansion part for any combination treatment arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Dabrafenib + LTT462 backbone arm 1 | Experimental | Drug: Dabrafenib, Drug: LTT462dose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer |
| Dabrafenib + LTT462 + trametinib triplet arm 1 | Experimental | Drug: Dabrafenib, Drug: LTT462, Drug: Trametinibdose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer |
| Dabrafenib + LTT462 + LXH254 triplet arm 2 | Experimental | Drug: Dabrafenib, Drug: LTT462, Drug: LXH254dose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer - Arm is closed for further enrollment. |
| Dabrafenib + LTT462 + TNO155 triplet arm 3 | Experimental | Drug: Dabrafenib, Drug: LTT462, Drug: TNO155dose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer |
| Dabrafenib + LTT462 + spartalizumab triplet arm 4 | Experimental | Drug: Dabrafenib, Drug: LTT462, Biological: Spartalizumabdose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer - Arm is closed for further enrollment. |
| Dabrafenib + trametinib + TNO155 triplet arm 5 | Experimental | Drug: Dabrafenib, Drug: Trametinib, Drug: TNO155dose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer |
| Dabrafenib + LTT462 + Tislelizumab triplet arm 6 | Experimental | Drug: Dabrafenib, Drug: LTT462, Biological: Tislelizumabdose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution's guidelines. Patients must be willing to undergo a new tumor biopsy at baseline and during on study therapy. Exceptions may be considered after documented discussion with Novartis.
- All patients must have a BRAF V600 mutation confirmed by local assessment.
- Patients with unresectable advanced/metastatic BRAF V600 cancer of the colon or rectum with measurable disease as determined by RECIST v1.1
- Patients must have documented disease progression following, or are intolerant to, 1 or 2 lines of chemotherapy for advanced/metastatic disease
Key exclusion criteria (9 listed)
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in-situ cervical cancer, or other tumors that will not affect life expectancy
- Impairment of gastrointestinal function or gastrointestinal disease that may signficantly alter the absorption of study drugs
- History of or current evidence/risk of retinal verin occlusion or serous retinopathy
- History of or current interstitial lung disease or non-infectious pneumonitis
- Patients with a known history of testing positive for HIV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DabrafenibAlso: DRB436, TafinlarCapsule for oral use | Drug | Dabrafenib + LTT462 + LXH254 triplet arm 2, Dabrafenib + LTT462 + TNO155 triplet arm 3, Dabrafenib + LTT462 + Tislelizumab triplet arm 6, Dabrafenib + LTT462 + spartalizumab triplet arm 4, Dabrafenib + LTT462 + trametinib triplet arm 1, Dabrafenib + LTT462 backbone arm 1, Dabrafenib + trametinib + TNO155 triplet arm 5 |
| LTT462Capsule for oral use | Drug | Dabrafenib + LTT462 + LXH254 triplet arm 2, Dabrafenib + LTT462 + TNO155 triplet arm 3, Dabrafenib + LTT462 + Tislelizumab triplet arm 6, Dabrafenib + LTT462 + spartalizumab triplet arm 4, Dabrafenib + LTT462 + trametinib triplet arm 1, Dabrafenib + LTT462 backbone arm 1 |
| TrametinibAlso: TMT212, MekinistTablet for oral use | Drug | Dabrafenib + LTT462 + trametinib triplet arm 1, Dabrafenib + trametinib + TNO155 triplet arm 5 |
| LXH254Tablet for oral use | Drug | Dabrafenib + LTT462 + LXH254 triplet arm 2 |
| TNO155Capsule for oral use | Drug | Dabrafenib + LTT462 + TNO155 triplet arm 3, Dabrafenib + trametinib + TNO155 triplet arm 5 |
| SpartalizumabAlso: PDR001Liquid in vial (Concentrate for solution for infusion) for intravenous use | Biological | Dabrafenib + LTT462 + spartalizumab triplet arm 4 |
| TislelizumabAlso: VDT482, BGBA317Liquid in vial (Concentrate for solution for infusion) for intravenous use | Biological | Dabrafenib + LTT462 + Tislelizumab triplet arm 6 |
Primary outcome
Incidence and nature of dose limiting toxicities (DLTs) in the first cycle
Time frame: 30 months
To characterize safety and tolerability of each treatment arm tested and identify recommended doses (RD) and regimens for future studies
Incidence and severity of AEs and SAEs, including changes in laboratory values, vital signs, and ECGs
Time frame: 34 months
To characterize safety and tolerability of each treatment arm tested and identify recommended doses and regimens for future studies
Frequency of dose interruptions
Time frame: 30 months
To characterize safety and tolerability of each treatment arm tested and identify recommended doses and regimens for future studies
Frequency of dose reductions
Time frame: 30 months
To characterize safety and tolerability of each treatment arm tested and identify recommended doses and regimens for future studies
Dose intensity
Time frame: 30 months
To characterize safety and tolerability of each treatment arm tested and identify recommended doses and regimens for future studies
10 secondary outcomes
AUClast derived from Serum/plasma concentration of individual investigational drugs within combination treatments
Time frame: 30 months
Best overall response (BOR)
Time frame: 34 months
Progression free survival (PFS)
Time frame: 34 months
Overall response rate (ORR)
Time frame: 34 months
Duration of response (DOR)
Time frame: 34 months
Disease control rate (DCR)
Time frame: 34 months
Change from baseline of the PD marker DUSP6 in tumor tissue (dose escalation only)
Time frame: 30 months
AUCtau derived from Serum/plasma concentration of individual investigational drugs within combination treatments
Time frame: 30 months
Cmax derived from Serum/plasma concentration of individual investigational drugs within combination treatments
Time frame: 30 months
Tmax derived from Serum/plasma concentration of individual investigational drugs within combination treatments
Time frame: 30 months
Results and safety
The study was stopped early (reason given: The decision of early termination was made due to business reasons, and was not based on any safety concerns for any of the treatment combinations.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- CADPT01C12101 Clinical Trial results FormLink provided by the sponsor.
- A Plain Language Trial Summary is available on www.novctrd.comLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
18 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dabrafenib, LTT462 and Trametinib in people with BRAF V600 Colorectal Cancer, run by Novartis Pharmaceuticals at 18 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Germany, Spain, Belgium, Australia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The decision of early termination was made due to business reasons, and was not based on any safety concerns for any of the treatment combinations.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and nature of dose limiting toxicities (DLTs) in the first cycle (time frame: 30 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.