Advanced MalignanciesPhase 1NCT05048134
A Phase I Study of HRS2300 or Combined With SHR-1316 or SHR-1701 or Trametinib or Almonertinib in Patients With Advanced Malignancies
A Phase 1 study testing HRS2300, HRS2300、 SHR-1316 and HRS2300、SHR-1701 in people with Advanced Malignancies, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the safety and tolerability of HRS2300 and combined with SHR-1316 or SHR-1701 or trametinib or Almonertinib.To Determine the maximum tolerated dose (MTD) and recommended Dose (RP2D) for HRS2300 monotherapy and combination therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Malignancies
- What is being tested?
- HRS2300, HRS2300、 SHR-1316 and HRS2300、SHR-1701
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteChina
- Study dates
- 25 Oct 2021to 23 May 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-75 years old，Male or female;
- Patients with pathologically confirmed advanced solid tumors who did not respond to standard treatment, did not tolerate standard treatment, or were determined by the investigator to be unsuitable for standard treatment;
- ECOG PS score of 0-1;
- Life expectancy of ≥3 months;
- Able and willing to provide a written informed consent.
Who cannot join
- Receiving chemotherapy, targeted therapy, immunotherapy, radical radiotherapy or surgical treatment for less than 4 weeks before study therapy (excluding tyrosine kinase inhibitors or other small molecule targeted drugs < 2 weeks); Four weeks prior to the start of study treatment (patients who have entered the follow-up period measured by the time of last use of the experimental drug or device) were enrolled in another clinical study;
- Drugs that affect the activity of metabolic enzyme CYP3A have been used in the past, and the eluting period from the end time to the first administration in this study is within 5 half-lives;
- Patients with active TB within 1 year prior to the start of drug therapy or with a history of active TB infection more than 1 year prior to the start of drug therapy without proper treatment were studied;
- Patients with other potential factors that may affect the study results or result in the premature discontinuation as determined by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Open-Label，Dose Escalation and Dose Expansion Phase I Study of HRS2300 Monotherapy or Combined With SHR-1316 or SHR-1701 or Trametinib or Almonertinib in Patients With Advanced Malignancies
The study is being conducted to evaluate the safety and tolerability of HRS2300 and combined with SHR-1316 or SHR-1701 or trametinib or Almonertinib.To Determine the maximum tolerated dose (MTD) and recommended Dose (RP2D) for HRS2300 monotherapy and combination therapy.
- Conditions
- Advanced Malignancies
- Being tested
- HRS2300, HRS2300、 SHR-1316, HRS2300、SHR-1701, HRS2300、trametinib, HRS2300、Almonertinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS2300Drug
HRS2300 monotherapy
HRS2300、 SHR-1316Drug
HRS2300 combined with SHR-1316
HRS2300、SHR-1701Drug
HRS2300 combined with SHR-1701
HRS2300、trametinibDrug
HRS2300 combined with trametinib
HRS2300、AlmonertinibDrug
HRS2300 combined with Almonertinib
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | Not described Receives: Drug: HRS2300 |
| Treatment group B | Experimental | Not described Receives: Drug: HRS2300、 SHR-1316 |
| Treatment group C | Experimental | Not described Receives: Drug: HRS2300、SHR-1701 |
| Treatment group D | Experimental | Not described Receives: Drug: HRS2300、trametinib |
| Treatment group E | Experimental | Not described Receives: Drug: HRS2300、Almonertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Dose limited toxicity（DLT）
Measured: Cycle 1( 4 weeks- monotherapy；3 weeks -combination）
Number of participants with adverse events
Measured: up to 3 years; at least once per treatment cycle
Determine RP2D of HRS2300 monotherapy and combination in patients with advanced malignancy
Enrolled sequentially from the initial dose of the trial, each subject received only one dose of the study drug and no other dose. The first subject of each dose should complete the first administration and be observed for 7 days before the other two subjects can be enrolled. After the DLT observation period of the last subject in each dose group has ended, the next dose increment can be entered. At the end of the dose escalation phase, the dose closest to the estimated toxicity probability of the target was selected as the MTD . At the end of the dose escalation, the SMC determined the RP2D based on the previous data.
Measured: through study completion，an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start25 Oct 2021
- Primary completion24 Feb 2023
- Study completion23 May 2023
Why it stopped: Sponsor R\&D strategy adjustment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced MalignanciesStudies 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
- Model description
- HRS2300 monotherapy or combined with SHR-1316, SHR-1701, trametinib, and Almonertinib
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
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
- NCT05048134
- Sponsor's protocol ID
- HRS2300-I-101
- Status last verified
- Sep 2024
- First submitted
- 31 Aug 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-Label，Dose Escalation and Dose Expansion Phase I Study of HRS2300 Monotherapy or Combined With SHR-1316 or SHR-1701 or Trametinib or Almonertinib in Patients With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT05048134
- Acronym / sponsor ID
- HRS2300-I-101
- Conditions
- Advanced Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor R\&D strategy adjustment
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 24 Feb 2023 (actual)
- Study completion
- 23 May 2023 (actual)
- First posted
- 17 Sep 2021 (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.
The study is being conducted to evaluate the safety and tolerability of HRS2300 and combined with SHR-1316 or SHR-1701 or trametinib or Almonertinib.To Determine the maximum tolerated dose (MTD) and recommended Dose (RP2D) for HRS2300 monotherapy and combination therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- HRS2300 monotherapy or combined with SHR-1316, SHR-1701, trametinib, and Almonertinib
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: HRS2300 |
| Treatment group B | Experimental | Drug: HRS2300、 SHR-1316 |
| Treatment group C | Experimental | Drug: HRS2300、SHR-1701 |
| Treatment group D | Experimental | Drug: HRS2300、trametinib |
| Treatment group E | Experimental | Drug: HRS2300、Almonertinib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18-75 years old，Male or female;
- Patients with pathologically confirmed advanced solid tumors who did not respond to standard treatment, did not tolerate standard treatment, or were determined by the investigator to be unsuitable for standard treatment;
- ECOG PS score of 0-1;
- Life expectancy of ≥3 months;
- Able and willing to provide a written informed consent.
Key exclusion criteria (4 listed)
- Receiving chemotherapy, targeted therapy, immunotherapy, radical radiotherapy or surgical treatment for less than 4 weeks before study therapy (excluding tyrosine kinase inhibitors or other small molecule targeted drugs < 2 weeks); Four weeks prior to the start of study treatment (patients who have entered the follow-up period measured by the time of last use of the experimental drug or device) were enrolled in another clinical study;
- Drugs that affect the activity of metabolic enzyme CYP3A have been used in the past, and the eluting period from the end time to the first administration in this study is within 5 half-lives;
- Patients with active TB within 1 year prior to the start of drug therapy or with a history of active TB infection more than 1 year prior to the start of drug therapy without proper treatment were studied;
- Patients with other potential factors that may affect the study results or result in the premature discontinuation as determined by the investigator.
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 |
|---|---|---|
| HRS2300HRS2300 monotherapy | Drug | Treatment group A |
| HRS2300、 SHR-1316HRS2300 combined with SHR-1316 | Drug | Treatment group B |
| HRS2300、SHR-1701HRS2300 combined with SHR-1701 | Drug | Treatment group C |
| HRS2300、trametinibHRS2300 combined with trametinib | Drug | Treatment group D |
| HRS2300、AlmonertinibHRS2300 combined with Almonertinib | Drug | Treatment group E |
Primary outcome
Number of participants with Dose limited toxicity（DLT）
Time frame: Cycle 1( 4 weeks- monotherapy；3 weeks -combination）
Number of participants with adverse events
Time frame: up to 3 years; at least once per treatment cycle
Determine RP2D of HRS2300 monotherapy and combination in patients with advanced malignancy
Time frame: through study completion，an average of 2 years
Enrolled sequentially from the initial dose of the trial, each subject received only one dose of the study drug and no other dose. The first subject of each dose should complete the first administration and be observed for 7 days before the other two subjects can be enrolled. After the DLT observation period of the last subject in each dose group has ended, the next dose increment can be entered. At the end of the dose escalation phase, the dose closest to the estimated toxicity probability of the target was selected as the MTD . At the end of the dose escalation, the SMC determined the RP2D based on the previous data.
Results and safety
The study was stopped early (reason given: Sponsor R\&D strategy adjustment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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.
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 HRS2300, HRS2300、 SHR-1316 and HRS2300、SHR-1701 in people with Advanced Malignancies, run by Jiangsu HengRui Medicine 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 5 inclusion and 4 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 19 Sep 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 was stopped early (reason given: Sponsor R\&D strategy adjustment). 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?
Number of participants with Dose limited toxicity（DLT） (time frame: Cycle 1( 4 weeks- monotherapy；3 weeks -combination）). The study lists 3 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 19 Sep 2024.