Solid TumorPhase 1NCT03118817
Expansion Study to Evaluate the Efficacy and Safety of HM95573 in BRAF, KRAS or NRAS Mutant Solid Cancers
A Phase 1 study testing HM95573 in people with Solid Tumor, run by Hanmi Pharmaceutical Company Limited at 7 sites in South Korea.
Trial summary
This study evaluates the anti-tumor efficacy and safety of single agent HM95573 administered in patients with solid tumors harboring mutations in either BRAF, KRAS or NRAS gene. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- HM95573
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 7 sitesSouth Korea
- Study dates
- 19 May 2017to 4 Feb 2020
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed solid tumor
- Confirmed mutations in either BRAF, KRAS or NRAS gene
- Eligible for biomarker analysis as follows:
- Be able to provide an archival tumor tissue at screening.
- Consent to undergo pre- and post-treatment tumor biopsies, provided sites of disease are easily and safely accessible
- Tumors for which standard therapy either does not exist or has proven ineffective or intolerable at study entry;
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- At least one lesion (excluding brain) measureable per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1;
- Life expectancy of ≥ 12 weeks;
- ECOG performance status score 0 or 1;
- Adequate organ function
Who cannot join
- Hematologic malignancy or double primary cancer.
- Treatment with any of the following:
- Anticancer therapy including chemotherapy, hormonal treatment, or radiotherapy within 14 days of the first dose of study drug.
- Investigational (not-approved) agent within 28 days or 5 fold of its half-life prior to the first dose of study drug.
- Major surgical procedure within 28 days prior to the first dose of study drug.
- Systemic corticosteroid (≥ 10mg prednisolone or equivalent dose of other anti-inflammatory corticosteroids) or systemic immunosuppressant within 28 days prior to the first dose of study drug or current systemic immunosuppressant which is required to be used continuously during treatment period of the study. But following treatments will be allowed: topical applications, inhaled sprays, eye drops, or local injections.
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- Treatment with nitrosourea, mitomycin, ipilimumab or other immunotherapy within 42 days prior to the first administration of study drug.
- >5 prior anticancer therapy regimens
- Spinal cord compression, leptomeningopathy or other symptomatic or uncontrolled central nervous system or brain metastasis.
- Cardiovascular abnormalities as follow:
- mean QTcF > 440 msec
- Heart failure of NYHA Class III or IV
- Heart metastasis
- Uncontrolled serum electrolyte disturbances (hyponatremia, hypokalemia, hypocalcemia or hypomagnesemia)
- History of acute coronary syndrome including unstable angina and myocardial infarction, uncontrolled arrhythmias (except for sinus arrhythmia and atrial fibrillation which is controlled within 30 days prior to the first dose of study drug), symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack within 6 months prior to the first dose of study drug.
- History of coronary angioplasty, coronary/peripheral artery bypass graft or stent insertion within 6 months prior to the first dose of study drug.
- History of congenital long QT syndrome or clinically significant ≥ Grade 2 (NCI-CTCAE version 4.03) ventricular or atrial dysrhythmias.
- Ophthalmologic disorders as follows:
- History of or evidence of retinal vein occlusion (RVO), central serous retinopathy (CSR) or neovascular macular degeneration at screening
- Glaucoma with intraocular pressure ≥ 21 mmHg
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Korea7 sites
Korea, Republic of, Chungcheongbuk-do
Cheongju-si, North Chungcheong, 28644
Korea, Republic of, Gyeongsangbuk-do
Daegu, Gyeongsangbuk-do, 41404
Korea, Republic of, Gyeonggi-do
Seongnam-si, Gyeonggi-do, 13620
Korea, Republic of, Seoul
Seoul, 03722
Korea, Republic of, Seoul
Seoul, 05505
Korea, Republic of, Seoul
Seoul, 06351
Korea, Republic of, Seoul
Seoul, 07061
About this study
Official title: A Single-arm, Open-label, Multi-center, Phase I Expansion Study Evaluating the Efficacy and Safety of HM95573 Monotherapy in Patients With BRAF, KRAS or NRAS Mutation-positive Solid Cancers
This study evaluates the anti-tumor efficacy and safety of single agent HM95573 administered in patients with solid tumors harboring mutations in either BRAF, KRAS or NRAS gene.
- Conditions
- Solid Tumor
- Being tested
- HM95573
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HM95573Drug
Dose: 450 mg BID
Regimen: twice daily (BID), continuous dosing
Duration: until progression disease or unacceptable toxicity develops
| Study group | Role | What they receive |
|---|---|---|
| HM95573 | Experimental | Single arm Receives: Drug: HM95573 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (Proportion of patients with reduction in tumor burden of a predefined amount)
Measured: At screening and every 8 weeks from time of first dosing until date of progression, start of other anticancer therapy or death whichever came first, assessed up to study completion (around 36 months).
Secondary outcomes (5)
Safety and tolerability by assessing adverse events (AEs) based on CTCAE ver.4.03
Measured: All AEs occurring up to 28 days after the last administration of study drug until the start of other anti-cancer treatment, whichever comes first, will be record.
Best overall response rate
Measured: At screening and every 8 weeks from time of first dosing until date of progression, start of other anticancer therapy or death whichever came first, assessed up to study completion (around 36 months).
Disease control rate
Measured: At screening and every 8 weeks from time of first dosing until date of progression, start of other anticancer therapy or death whichever came first, assessed up to study completion (around 36 months).
Progression-free survival
Measured: At screening and every 8 weeks from time of first dosing until date of progression, start of other anticancer therapy or death whichever came first, assessed up to study completion (around 36 months).
Changes in molecular biomarkers
Measured: Screening and 15 days after first dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start19 May 2017
- Primary completion4 Feb 2020
- Study completion4 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Hanmi Pharmaceutical Company LimitedThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03118817
- Sponsor's protocol ID
- HM-RAFI-102
- Status last verified
- Aug 2020
- First submitted
- 20 Mar 2017
- Last updated
- 10 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label, Multi-center, Phase I Expansion Study Evaluating the Efficacy and Safety of HM95573 Monotherapy in Patients With BRAF, KRAS or NRAS Mutation-positive Solid Cancers
- ClinicalTrials.gov ID
- NCT03118817
- Acronym / sponsor ID
- HM-RAFI-102
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 19 May 2017 (actual)
- Primary completion
- 4 Feb 2020 (actual)
- Study completion
- 4 Feb 2020 (actual)
- First posted
- 18 Apr 2017 (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.
This study evaluates the anti-tumor efficacy and safety of single agent HM95573 administered in patients with solid tumors harboring mutations in either BRAF, KRAS or NRAS gene.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HM95573 | Experimental | Drug: HM95573Single arm |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically confirmed solid tumor
- Confirmed mutations in either BRAF, KRAS or NRAS gene
- Eligible for biomarker analysis as follows:
- Tumors for which standard therapy either does not exist or has proven ineffective or intolerable at study entry;
- At least one lesion (excluding brain) measureable per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1;
Key exclusion criteria (20 listed)
- Hematologic malignancy or double primary cancer.
- Treatment with any of the following:
- Spinal cord compression, leptomeningopathy or other symptomatic or uncontrolled central nervous system or brain metastasis.
- Cardiovascular abnormalities as follow:
- Ophthalmologic disorders as follows:
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 |
|---|---|---|
| HM95573Dose: 450 mg BID Regimen: twice daily (BID), continuous dosing Duration: until progression disease or unacceptable toxicity develops | Drug | HM95573 |
Primary outcome
Objective response rate (Proportion of patients with reduction in tumor burden of a predefined amount)
Time frame: At screening and every 8 weeks from time of first dosing until date of progression, start of other anticancer therapy or death whichever came first, assessed up to study completion (around 36 months).
5 secondary outcomes
Safety and tolerability by assessing adverse events (AEs) based on CTCAE ver.4.03
Time frame: All AEs occurring up to 28 days after the last administration of study drug until the start of other anti-cancer treatment, whichever comes first, will be record.
Best overall response rate
Time frame: At screening and every 8 weeks from time of first dosing until date of progression, start of other anticancer therapy or death whichever came first, assessed up to study completion (around 36 months).
Disease control rate
Time frame: At screening and every 8 weeks from time of first dosing until date of progression, start of other anticancer therapy or death whichever came first, assessed up to study completion (around 36 months).
Progression-free survival
Time frame: At screening and every 8 weeks from time of first dosing until date of progression, start of other anticancer therapy or death whichever came first, assessed up to study completion (around 36 months).
Changes in molecular biomarkers
Time frame: Screening and 15 days after first dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2020.
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HM95573 in people with Solid Tumor, run by Hanmi Pharmaceutical Company Limited at 7 sites in South Korea.
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 10 inclusion and 20 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: finished, as of the sponsor's last update on 10 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in South Korea. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Objective response rate (Proportion of patients with reduction in tumor burden of a predefined amount) (time frame: At screening and every 8 weeks from time of first dosing until date of progression, start of other anticancer therapy or death whichever came first, assessed up to study completion (around 36 months).). 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 10 Aug 2020.