Advanced Solid TumorPhase 1NCT03466268
Study to Evaluate the Safety and Anti-tumor Activity of SCC244
A Phase 1 study testing Gumarontinib Tablets in people with Advanced Solid Tumor, run by Haihe Biopharma Co., Ltd. at 1 site in China.
Trial summary
This study evaluates the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of SCC244 in patients with advanced solid tumors with c-Met Alterations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- Gumarontinib Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 14 Sep 2017to 9 Jan 2023
- 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
- Male or female subject ≥ 18 years of age.
- Life expectancy ≥ 12 weeks by the Investigator.
- In Phase Ia, histologically confirmed NSCLC (including sarcomatoid carcinoma) with c-Met alterations defined as c-Met gene amplification ≥ 5 copies or c-Met protein overexpression (IHC 3+) or c-Met exon 14 skipping mutation. No EGFR T790M mutation for subjects with c-Met gene amplification or c-Met protein overexpression; KRAS/ALK/ROS1 WT or unknown mutation/rearrangement status for subjects with c-Met exon 14 skipping mutation.
- In Phase Ib, histologically confirmed NSCLC as in Phase Ia, AGC, or HCC with c-Met gene amplification ≥ 5 copies, or c-Met protein overexpression (IHC 3+). HCC subjects must have Child Pugh Class A.
- Available fresh samples of NSCLC (except for c-Met exon 14 skipping mutation that can be from archival tumor sample), and available fresh or archival tumor sample of AGC and HCC for c-Met gene alteration characterization or determination of c-Met protein overexpression (IHC 3+). Fine needle aspiration and cytology samples are not sufficient.
- In Phase Ia/Ib, all NSCLC subjects with EGFR mutation must have progressive disease after 1 or 2 lines of prior therapy including at least an EGFR-TKI targeting other than c-Met alterations. Subjects with c-Met exon 14 skipping mutation must have received at least 1 line of standard therapy in Phase Ia and can be first or second line subjects in Phase Ib. In Phase Ib, subjects with AGC must have progressive disease after at least 1 line of prior standard therapy and subjects with HCC must have received 1 line of targeted agent therapy.
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- At least 1 measurable target lesion.
- Eastern Cooperative Oncology Group (ECOG) performance score 0-2.
- Adequate organ function as documented
- Toxicities from any prior therapy, surgery, or radiotherapy must have resolved to Grade 0 or 1 as per the National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE), excluding alopecia.
Who cannot join
- Pregnant (serum human chorionic gonadotropin positive) or breastfeeding female subject.
- Prior anti-tumor systemic chemotherapy or loco-regional therapy for HCC (such as percutaneous ethanol injection, chemoembolization or radiofrequency ablation), biologics therapy, Chinese herbal anti-cancer or anti-infective medication within 28 days or 5 × half life time, whichever occurs last, before the first dose.
- Prior therapy with another c-Met inhibitor.
- Presence of EGFR T790M mutation in NSCLC subjects pretreated with an EGFR-TKI; Known KRAS/ALK/ROS1 mutation/rearrangement in NSCLC subjects with c-Met exon 14 skipping mutation.
- Known or suspected hypersensitivity to SCC244 and/or its excipients.
- Palliative radiotherapy to bone metastasis within 4 weeks prior to the first dosing.
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- Prior or concomitant other malignant tumor (except effectively controlled non-melanoma skin cancer, breast carcinoma in situ or cervix cancer in situ and superficial bladder cancer within past 5 years).
- Cardiac function impairment or clinically significant heart disease including congestive heart-failure ≥ Grade 2 according to grading of New York Heart Association, arrhythmia, conduction abnormality requiring treatment, myocardium diseases or uncontrollable hypertension within 6 months prior to screening. QTc-prolongation > 470 msec, risk factors for Torsades De Pointe, hypokalemia or family history of long-QT-Syndrome.
- History of stroke within 6 months prior to screening.
- Known central nervous system or brain metastasis that is either symptomatic or untreated. Metastases that have been treated by complete resection and/or radiotherapy demonstrating stability or improvement are not an exclusion criterion provided they are stable as shown by CT scan for at least 1 month without evidence of cerebral edema and no requirements for corticosteroids or anticonvulsants.
- Inability to swallow oral medication, or active digestive system disease, or major digestive surgery, which in the Investigator's opinion can affect administration and absorption of SCC244 (such as active ulcerative disease, uncontrollable diarrhea, and small bowel resection).
- Any disease or condition with clinical significance (such as pancreatitis, uncontrollable diabetes, active or uncontrollable infection, drug or alcohol abuse, or psychiatric conditions), which can affect protocol compliance.
- Positive result for active infection by hepatitis B or C virus (HBV or HCV); known positivity for human immunodeficiency virus (HIV) infection.
- Men and women of reproductive potential not willing or not able to employ a highly effective method of birth control/contraception to prevent pregnancy until the end of trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Trial to Assess the Safety, Pharmacokinetics, and Anti-tumor Activity of SCC244 in Subjects With Advanced Solid Tumors
This study evaluates the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of SCC244 in patients with advanced solid tumors with c-Met Alterations.
Read the detailed description
A Phase I Dose Escalation and Dose Expansion Trial to Evaluate the Safety, Pharmacokinetics and Anti-tumor Activity of SCC244, a Highly Selective c-Met Inhibitor, in Patients with Advanced Non-small Cell Lung Cancer.
Phase Ia: The primary objective is to determine the MTD, BED and recommended dose for Phase Ib in patients with advanced NSCLCs. In addition, the safety, tolerability, preliminary efficacy and PK of SCC244 and its metabolites will also be evaluated. In phase Ia, planned dose levels will be evaluated with a starting dose of 100mg.
Phase Ib: The primary objective is to assess the ORR in advanced NSCLC patients with c-MET change. The DOR, DCR, TTR, PFS, one-year OS rate, safety, tolerability, and PK will also be evaluation in Phase Ib.
- Conditions
- Advanced Solid Tumor
- Being tested
- Gumarontinib Tablets
- Keywords
- Safety, Tolerability, Pharmacokinetics, Anti-tumor activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gumarontinib TabletsDrug
Also called SCC244
Either at 100mgSD、100mgQD、200mgSD、200mgQD、400mgSD、400mgQD、300mgBID、400mgBID
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation study of Gumarontinib | Experimental | To determine the maximum tolerated dose (MTD) of Gumarontinib Receives: Drug: Gumarontinib Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT(Dose limit toxity)
To evaluate the DLT in patients with advanced solid tumor
Measured: 35 days
MTD(Max tolerance does)
To evaluate the MTD in patients with advanced solid tumor
Measured: 35 days
BED(Biological effective dose)
To evaluate the BED in patients with advanced solid tumor
Measured: 35 days
ORR(Objective response rate)
To evaluate the ORR in patients with advanced solid tumor in Ib
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study start14 Sep 2017
- Primary completion9 Jan 2023
- Study completion9 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haihe Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yilong Wu, M.D., Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03466268
- Sponsor's protocol ID
- SCC244-101
- Status last verified
- Mar 2024
- First submitted
- 7 Aug 2017
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial to Assess the Safety, Pharmacokinetics, and Anti-tumor Activity of SCC244 in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT03466268
- Acronym / sponsor ID
- SCC244-101
- Conditions
- Advanced Solid Tumor
- Keywords
- Safety, Tolerability, Pharmacokinetics, Anti-tumor activity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Haihe Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Sep 2017 (actual)
- Primary completion
- 9 Jan 2023 (actual)
- Study completion
- 9 Jan 2023 (actual)
- First posted
- 15 Mar 2018 (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 Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of SCC244 in patients with advanced solid tumors with c-Met Alterations.
Detailed description
A Phase I Dose Escalation and Dose Expansion Trial to Evaluate the Safety, Pharmacokinetics and Anti-tumor Activity of SCC244, a Highly Selective c-Met Inhibitor, in Patients with Advanced Non-small Cell Lung Cancer.
Phase Ia: The primary objective is to determine the MTD, BED and recommended dose for Phase Ib in patients with advanced NSCLCs. In addition, the safety, tolerability, preliminary efficacy and PK of SCC244 and its metabolites will also be evaluated. In phase Ia, planned dose levels will be evaluated with a starting dose of 100mg.
Phase Ib: The primary objective is to assess the ORR in advanced NSCLC patients with c-MET change. The DOR, DCR, TTR, PFS, one-year OS rate, safety, tolerability, and PK will also be evaluation in Phase Ib.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose escalation study of Gumarontinib | Experimental | Drug: Gumarontinib TabletsTo determine the maximum tolerated dose (MTD) of Gumarontinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female subject ≥ 18 years of age.
- Life expectancy ≥ 12 weeks by the Investigator.
- In Phase Ia, histologically confirmed NSCLC (including sarcomatoid carcinoma) with c-Met alterations defined as c-Met gene amplification ≥ 5 copies or c-Met protein overexpression (IHC 3+) or c-Met exon 14 skipping mutation. No EGFR T790M mutation for subjects with c-Met gene amplification or c-Met protein overexpression; KRAS/ALK/ROS1 WT or unknown mutation/rearrangement status for subjects with c-Met exon 14 skipping mutation.
- In Phase Ib, histologically confirmed NSCLC as in Phase Ia, AGC, or HCC with c-Met gene amplification ≥ 5 copies, or c-Met protein overexpression (IHC 3+). HCC subjects must have Child Pugh Class A.
- Available fresh samples of NSCLC (except for c-Met exon 14 skipping mutation that can be from archival tumor sample), and available fresh or archival tumor sample of AGC and HCC for c-Met gene alteration characterization or determination of c-Met protein overexpression (IHC 3+). Fine needle aspiration and cytology samples are not sufficient.
Key exclusion criteria (14 listed)
- Pregnant (serum human chorionic gonadotropin positive) or breastfeeding female subject.
- Prior anti-tumor systemic chemotherapy or loco-regional therapy for HCC (such as percutaneous ethanol injection, chemoembolization or radiofrequency ablation), biologics therapy, Chinese herbal anti-cancer or anti-infective medication within 28 days or 5 × half life time, whichever occurs last, before the first dose.
- Prior therapy with another c-Met inhibitor.
- Presence of EGFR T790M mutation in NSCLC subjects pretreated with an EGFR-TKI; Known KRAS/ALK/ROS1 mutation/rearrangement in NSCLC subjects with c-Met exon 14 skipping mutation.
- Known or suspected hypersensitivity to SCC244 and/or its excipients.
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 |
|---|---|---|
| Gumarontinib TabletsAlso: SCC244Either at 100mgSD、100mgQD、200mgSD、200mgQD、400mgSD、400mgQD、300mgBID、400mgBID | Drug | Dose escalation study of Gumarontinib |
Primary outcome
DLT(Dose limit toxity)
Time frame: 35 days
To evaluate the DLT in patients with advanced solid tumor
MTD(Max tolerance does)
Time frame: 35 days
To evaluate the MTD in patients with advanced solid tumor
BED(Biological effective dose)
Time frame: 35 days
To evaluate the BED in patients with advanced solid tumor
ORR(Objective response rate)
Time frame: 8 weeks
To evaluate the ORR in patients with advanced solid tumor in Ib
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 9 Oct 2024.
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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.
Yilong Wu, M.D. principal investigator
Guangdong Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gumarontinib Tablets in people with Advanced Solid Tumor, run by Haihe Biopharma Co., Ltd. at 1 site in China.
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 14 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 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
DLT(Dose limit toxity) (time frame: 35 days). The study lists 4 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 9 Oct 2024.