Solid Tumor, AdultPhase 1NCT03398720
Safety and Tolerability of HTI-1066 in Subjects With Advanced Solid Tumors
A Phase 1 study testing HTI-1066 dose level 1, HTI-1066 dose level 2 and HTI-1066 dose level 3 in people with Solid Tumor, Adult, run by Jiangsu HengRui Medicine Co., Ltd. at 3 sites in United States.
Trial summary
HTI-1066 is a novel ADC being developed for the treatment of cancers in patients with overexpression of c-Met. This 2-part, Phase 1 study evaluates the safety the tolerability of HTI-1066 in subjects with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- HTI-1066 dose level 1, HTI-1066 dose level 2 and HTI-1066 dose level 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- 31 Dec 2017to 31 Dec 2019
- 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 ≥18 years of age
- Subject must have an advanced solid tumor
- ECOG Performance Status of 0 or 1
- Life expectancy ≥12 weeks
- Adequate laboratory parameters
- Female subjects agree not to be pregnant or lactating from beginning of the study screening until 4 months after receiving the last treatment; Male and female subjects and their sexual partners are willing and able to employ a highly effective method of birth control/contraception.
- Willing and able to comply with clinic visits and study-related procedures
- Provide signed informed consent
Who cannot join
- Hypersensitivity to HTI-1066 or sensitivity to humanized monoclonal antibody products
- Any concurrent therapy for cancer, radiation, or surgery within 4 weeks, except for minor palliative intent (this is to be discussed with sponsor)
- Any concurrent use of anti-infective, anti-fungal, or anti-viral agent (exceptions are to be approved by the sponsor)
- Any other prohibited or restricted medication as described in the study protocol.
- Investigational therapy administered <5 half-lives before the first dose of HTI-1066
- Any anticancer therapy administered <5 half-lives before first dose of HTI-1066; any prior immune-oncology products administered within 4 weeks or 5 half-lives before the first dose of HTI-1066 as described above; or surgery or radiotherapy administered within 4 weeks before the first dose of HTI-1066.
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- Active CNS metastases.
- Cardiac disease (NYHA classes II-IV) including myocardial infarction within 6 months before enrollment, or unstable angina, congestive heart failure, or cardiac arrhythmia requiring treatment.
- History or presence of an abnormal ECG, ECHO, or MUGA that is clinically meaningful.
- History of immunodeficiency including seropositivity for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease, or any active systemic viral infection requiring therapy (e.g., hepatitis B or C)
- Any other medical, psychiatric, or social condition deemed by the investigator to be likely to interfere with a subject's rights, safety, welfare or ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results
- Active infection or an unexplained fever >38.5°C during Screening or on the first scheduled day of dosing.
- Unresolved toxicities from previous anticancer therapy.
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Not yet recruiting
MD Anderson Cancer Center
Houston, Texas, 77230
Siqing Fu, MD, 713-792-4318, siqingfu@mdanderson.org
- Not yet recruiting
Sarah Cannon - Tennessee Oncology
Nashville, Tennessee, 37203
Howard A Burris, MD, howard.burris@sarahcannon.com
- Recruiting
Honor Health Research Institute
Scottsdale, Arizona, 85258
Vivek Khemka, MD, MBA, FACP, vivek.khemka@honorhealth.com
About this study
Official title: A Two-Part, Phase 1, Open-Label, Multicenter, Non-Randomized, Dose Escalation/Expansion Study to Evaluate the Safety and Tolerability of HTI-1066 in Subjects With Advanced Solid Tumors
HTI-1066 is a novel ADC being developed for the treatment of cancers in patients with overexpression of c-Met. This 2-part, Phase 1 study evaluates the safety the tolerability of HTI-1066 in subjects with advanced solid tumors.
Read the detailed description
This is a 2-part dose escalation and dose expansion study. Dose escalation uses a modified "3+3" design and continues until a maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) is identified. In part 2, subjects with selected tumor types will be enrolled at the MTD or RP2D.
- Conditions
- Solid Tumor, Adult
- Being tested
- HTI-1066 dose level 1, HTI-1066 dose level 2, HTI-1066 dose level 3, HTI-1066 dose level 4
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HTI-1066 dose level 1Drug
Starting dose level
HTI-1066 dose level 2Drug
2nd dose level
HTI-1066 dose level 3Drug
3rd dose level
HTI-1066 dose level 4Drug
4th dose level
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | One participant will receive HTI-1066 at the starting dose. Receives: Drug: HTI-1066 dose level 1 |
| Cohort 2 | Experimental | Participants will receive HTI-1066 at dose level 2. Receives: Drug: HTI-1066 dose level 2 |
| Cohort 3 | Experimental | Participants will receive HTI-1066 at dose level 3. Receives: Drug: HTI-1066 dose level 3 |
| Cohort 4 | Experimental | Participants will receive HTI-1066 at dose level 4. Receives: Drug: HTI-1066 dose level 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Number of participants with AEs and SAEs
Measured: Up to 2 year
Dose-limiting toxicity (DLT)
Number of participants with DLTs
Measured: Up to 2 years
Secondary outcomes (5)
AUC
Area under the curve
Measured: Up to 1 year
Cmax
Peak concentration at Tmax
Measured: Up to 1 year
Anti-drug antibodies
Measured: Up to 2 year
Objective response rate
Measured: Up to 2 years
Progression-free survival (PFS)
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start31 Dec 2017
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03398720
- Sponsor's protocol ID
- HTI-1066-101
- Status last verified
- Jan 2018
- First submitted
- 26 Dec 2017
- Last updated
- 12 Jan 2018
- 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 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Part, Phase 1, Open-Label, Multicenter, Non-Randomized, Dose Escalation/Expansion Study to Evaluate the Safety and Tolerability of HTI-1066 in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT03398720
- Acronym / sponsor ID
- HTI-1066-101
- Conditions
- Solid Tumor, Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Dec 2017 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 12 Jan 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.
HTI-1066 is a novel ADC being developed for the treatment of cancers in patients with overexpression of c-Met. This 2-part, Phase 1 study evaluates the safety the tolerability of HTI-1066 in subjects with advanced solid tumors.
Detailed description
This is a 2-part dose escalation and dose expansion study. Dose escalation uses a modified "3+3" design and continues until a maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) is identified. In part 2, subjects with selected tumor types will be enrolled at the MTD or RP2D.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: HTI-1066 dose level 1One participant will receive HTI-1066 at the starting dose. |
| Cohort 2 | Experimental | Drug: HTI-1066 dose level 2Participants will receive HTI-1066 at dose level 2. |
| Cohort 3 | Experimental | Drug: HTI-1066 dose level 3Participants will receive HTI-1066 at dose level 3. |
| Cohort 4 | Experimental | Drug: HTI-1066 dose level 4Participants will receive HTI-1066 at dose level 4. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female ≥18 years of age
- Subject must have an advanced solid tumor
- ECOG Performance Status of 0 or 1
- Life expectancy ≥12 weeks
- Adequate laboratory parameters
Key exclusion criteria (13 listed)
- Hypersensitivity to HTI-1066 or sensitivity to humanized monoclonal antibody products
- Any concurrent therapy for cancer, radiation, or surgery within 4 weeks, except for minor palliative intent (this is to be discussed with sponsor)
- Any concurrent use of anti-infective, anti-fungal, or anti-viral agent (exceptions are to be approved by the sponsor)
- Any other prohibited or restricted medication as described in the study protocol.
- Investigational therapy administered <5 half-lives before the first dose of HTI-1066
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 |
|---|---|---|
| HTI-1066 dose level 1Starting dose level | Drug | Cohort 1 |
| HTI-1066 dose level 22nd dose level | Drug | Cohort 2 |
| HTI-1066 dose level 33rd dose level | Drug | Cohort 3 |
| HTI-1066 dose level 44th dose level | Drug | Cohort 4 |
Primary outcome
Adverse events
Time frame: Up to 2 year
Number of participants with AEs and SAEs
Dose-limiting toxicity (DLT)
Time frame: Up to 2 years
Number of participants with DLTs
5 secondary outcomes
AUC
Time frame: Up to 1 year
Cmax
Time frame: Up to 1 year
Anti-drug antibodies
Time frame: Up to 2 year
Objective response rate
Time frame: Up to 2 years
Progression-free survival (PFS)
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2018.
- 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.
3 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 HTI-1066 dose level 1, HTI-1066 dose level 2 and HTI-1066 dose level 3 in people with Solid Tumor, Adult, run by Jiangsu HengRui Medicine Co., Ltd. at 3 sites in United States.
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 8 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 12 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Junsheng Wang, MD, PhD (+609 423 2155 ext. 205, junsheng.wang@hengruitherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: Up to 2 year). The study lists 2 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 12 Jan 2018.