Non-small Cell Lung CancerPhase 1/2NCT05552781
H002 in Patients With EGFR Mutation Locally Advanced or Metastatic NSCLC
A Phase 1/2 study testing H002 capsule in people with Non-small Cell Lung Cancer, run by RedCloud Bio at 8 sites in China.
Trial summary
This is a phase I/IIa, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, PK and preliminary anti-tumor activity of H002 when given orally in patients with EGFR mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- H002 capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 8 sitesChina
- Study dates
- 26 Aug 2022to 28 Feb 2025
- Phase
- Phase 1/2
- 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
- Males or females aged ≥ 18 years at time of signing informed consent form (ICF).
- Histological or cytological confirmed diagnosis of unresectable locally advanced or metastatic NSCLC.
- Subjects must have NSCLC harboring one or more active EGFR mutations known to be associated with EGFR-TKI sensitivity (including, but not limited to Del19 and L858R).
- Part A: All subjects may provide tumor sample to central laboratory to analyze the EGFR mutation status according to their own willingness;
- Part B: All subjects must provide tumor sample to central laboratory to analyze the EGFR mutation status. And subjects must have NSCLC harboring EGFR C797S mutation.
- Note: Tumor sample can be either an archival sample or a sample obtained by pretreatment biopsy prior to H002 treatment.
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- • Part A: Subjects have received the best treatment available as determined by the physician and must have radiological documented disease progression on the last treatment administered prior to enrolling in the study.
- Part B: Subjects have received at least one previous EGFR-TKI treatment and have radiological documented disease progression on the previous continuous EGFR-TKI treatment. In addition, subjects may have received other antitumor treatments and must have radiological documented disease progression on the last treatment administered prior to enrolling in the study.
- Presence of at least one measurable lesion according to RECIST v1.1 per investigator assessment.
- ECOG performance status of 0-1.
- Life expectancy ≥ 12 weeks.
- Adequate hematologic and organ function per protocol.
- Women of childbearing potential (WOCBP) and fertile males with WOCBP partners must use highly effective contraception per protocol throughout the study. WOCBP must have a negative serum and/or urine pregnancy test result within 7 days prior to the first dose of H002.
- Signed ICF, and this must be obtained before the performance of any protocol-specific procedures.
Who cannot join
- Treatment with any of the following:
- Prior treatment with an EGFR-TKI within 8 days or approximately 5 × t1/2 prior to the first dose of H002, whichever is longer; Prior treatment with immunotherapy or biotherapy within 4 weeks prior to the first dose of H002; Radiotherapy (palliative radiotherapy is completed at least 2 weeks prior to the first dose of H002 can be enrolled) within 4 weeks prior to the first dose of H002; Herbal therapy that has anti-tumor effects within 2 weeks prior to the first dose of H002; Mitomycin and nitrosourea within 6 weeks prior to the first dose of H002; Oral fluorouracil such as tegafur and capecitabine within 2 weeks prior to the first dose of H002; Chemotherapy (except for mitomycin, nitrosourea, and fluorouracil oral drugs), or other anti-tumor drugs for the treatment of NSCLC within 4 weeks or approximately 5 × t1/2 prior to the first dose of H002, whichever is longer.
- Subjects with EGFR exon 20 insertion mutations only.
- Prior marketed and/or investigational treatment for EGFR C797S mutation (including, but not limited to BTP-661411, TQB3804 and BLU-945).
- Is currently participating and receiving investigational therapy or using an investigational device, or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks or 5 × t1/2 of the investigational product, whichever is longer, prior to the first dose of H002.
- Is expected to require any other form of anti-tumor therapy while on study.
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- Unresolved toxicity greater than CTCAE v5.0 Grade 1 from prior anti-tumor therapy.
- ≥ CTCAE v5.0 Grade 2 skin toxicity at screening.
- Treatment with strong inhibitors and strong inducers of CYP3A4 within 2 weeks prior to the first dose of H002, or anticipation of need for such drugs during study treatment.
- Uncontrollable pleural effusion, ascites, or pericardial effusion.
- Subjects who have symptomatic brain metastases, meningeal metastasis or spinal cord compression.
- Subjects who have a chronic or active infection that required systemic treatment within 2 weeks prior to the first dose of H002.
- Subjects who have gastrointestinal disorders that will affect oral administration or the investigator judges that the absorption of H002 will be interfered.
- History of hypersensitivity to active or inactive excipients of H002 or drugs with a similar chemical structure or class to H002.
- Subjects who received a diagnosis of, and/or tested positive at screening for human immunodeficiency virus (HIV).
- Subjects with active hepatitis B.
- Presence or history of malignancy other than NSCLC with the exception of some certain early-stage cancers.
- Subjects who have clinically significant cardiovascular diseases that occurred within 6 months prior to the first dose of H002, include but not limited to QTc interval ≥ 450 msec (male) or ≥ 470 msec (female).
- Major surgery or significant traumatic injury occurring within 4 weeks prior to the first dose of H002 or anticipation of need for a major surgery during the study.
- Medical history of ILD.
- Medical history of severe eye disease without recovery to CTCAE v5.0 Grade 0 or 1.
- Severe gastrointestinal disease within 4 weeks prior to the first dose of H002 and did not recover to ≤ CTCAE v5.0 Grade 2.
- Has any bleeding tendency or coagulopathy within 6 months prior to the first dose of H002.
- Administration of a live, attenuated vaccine within 4 weeks prior to the first dose of H002 or anticipation of need for such a vaccine during the study.
- Female subjects in pregnancy or lactation.
- Any other circumstances that would, in the investigator's judgment, prevent the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites, 8 recruiting
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410000
Lin Wu, Doctor, wulin-calf@vip.163.com
Jia Li, Doctor, lijia@hnca.org.cn
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610044
Yongsheng Wang, Doctor, wangys@wchscu.cn
Yue Chen, Doctor, cy9209@163.com
- Not yet recruiting
Harbin Medical University Cancer Hospital
Haerbin, Heilongjiang, 150081
Yan Yu, Doctor, gpyuyan@163.com
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310000
Yiping Zhang, Doctor, zhangyp@zjcc.org.cn
Zhengbo Song, Doctor, songzb@zjcc.org.cn
- Recruiting
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Jianying Zhou, Doctor, drzjy@163.com
Junjun Chen, Doctor, chenjunjun1985@126.com
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 20030
Shun Lu, Doctor, +86 21 2220-0000, Shun_lu@hotmail.com
Yongfeng Yu, Doctor, +86 21 2220-0000, yuyongfeng212@sina.com
- Not yet recruiting
Union Hospital Affiliated to Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Xiaorong Dong, Doctor, xhzzdxr@126.com
Ruiguang Zhang, Doctor, zrg27@163.com
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Mingjun Li, Doctor, didilmj4505@sina.com
Qianqian Wang, Doctor, wangqqyfy@163.con
About this study
Official title: A Phase I/IIa, Open-label, Dose-escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Preliminary Anti-tumor Activity of H002 in Patients With EGFR Mutation Locally Advanced or Metastatic NSCLC
This is a phase I/IIa, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, PK and preliminary anti-tumor activity of H002 when given orally in patients with EGFR mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).
The study will contain two parts: Part A is dose escalation phase (i.e., Phase I) and Part B is dose expansion phase (i.e., Phase IIa).
Read the detailed description
Part A (Dose Escalation Phase) Approximately 36 subjects will be enrolled, based on the "3+3" design for dose escalation and safety evaluation requirements. The total number of subjects will depend upon the number of dose escalations necessary.
Part B (Dose Expansion Phase) Up to 20 subjects will be enrolled in each expansion arm, the total number of subjects will depend upon the number of dose expansions (expansions may be at more than one dose depending upon emerging data).
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- H002 capsule
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H002 capsuleDrug
Also called H002
Small molecule, Capsule
| Study group | Role | What they receive |
|---|---|---|
| 20 mg QD, oral | Experimental | H002 20mg QD, orally administered in fasting state, receive a single dose of H002 orally, followed by a 4-day washout period. Then, the same dose of H002 will be administered QD until disease progression or not tolerated. Receives: Drug: H002 capsule |
| 40 mg QD, oral | Experimental | H002 40mg QD, orally administered in fasting state, receive a single dose of H002 orally, followed by a 4-day washout period. Then, the same dose of H002 will be administered QD until disease progression or not tolerated. Receives: Drug: H002 capsule |
| 80 mg QD, oral | Experimental | H002 80mg QD, orally administered in fasting state, receive a single dose of H002 orally, followed by a 4-day washout period. Then, the same dose of H002 will be administered QD until disease progression or not tolerated. Receives: Drug: H002 capsule |
| 150 mg QD, ora | Experimental | H002 150mg QD, orally administered in fasting state, receive a single dose of H002 orally, followed by a 4-day washout period. Then, the same dose of H002 will be administered QD until disease progression or not tolerated. Receives: Drug: H002 capsule |
| 250 mg QD, oral | Experimental | H002 250mg QD, orally administered in fasting state, receive a single dose of H002 orally, followed by a 4-day washout period. Then, the same dose of H002 will be administered QD until disease progression or not tolerated. Receives: Drug: H002 capsule |
| 350 mg QD, oral | Experimental | H002 350mg QD, orally administered in fasting state, receive a single dose of H002 orally, followed by a 4-day washout period. Then, the same dose of H002 will be administered QD until disease progression or not tolerated. Receives: Drug: H002 capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
DOSE ESCALATION PHASE：Incidence of dose-limiting toxicities (DLTs) at Cycle 0 and Cycle1. Incidence and severity of treatment-emergent adverse events (TEAEs), with severity determined according to National Cancer Institute (NCI) CTCAE v5.0.
To evaluate the safety and tolerability of H002 and to determine the maximal tolerable dose (MTD), or if possible, a dose/exposure predicted to result in optimal biological dose (OBD) or recommended phase II dose (RP2D).
Measured: At the end of Cycle 1 (include 4 days in Cycle 0 and 21 days in Cycle1)
DOSE EXPANSION PHASE：Objective Response Rate (ORR)
To obtain a preliminary evaluation of the anti-tumor activity at the selected dose(s) of H002 when given orally as determined according to RECIST v1.1.
Measured: [Time Frame: Up to approximately 30 months]
DOSE EXPANSION PHASE：To evaluate the incidence and severity of TEAEs, with severity determined according to NCI CTCAE v5.0.
To evaluate the safety at the selected dose(s) of H002 when given orally.
Measured: Up to approximately 30 months
Secondary outcomes (10)
Peak Plasma Concentration (Cmax)
To evaluate the pharmacokinetic (PK) characteristics of H002 when given orally following single and multiple doses.
Measured: Up to approximately 30 months
Time to reach maximum concentration (Tmax)
To evaluate the pharmacokinetic (PK) characteristics of H002 when given orally following single and multiple doses.
Measured: Up to approximately 30 months
Area under the plasma concentration versus time curve (AUC)
To evaluate the pharmacokinetic (PK) characteristics of H002 when given orally following single and multiple doses.
Measured: Up to approximately 30 months
Time for half the drug concentration to be eliminated（t1/2）
To evaluate the pharmacokinetic (PK) characteristics of H002 when given orally following single and multiple doses.
Measured: Up to approximately 30 months
DOSE ESCALATION PHASE：Objective Response Rate (ORR)
To obtain a preliminary evaluation of the anti-tumor activity of H002 when given orally as determined according to response evaluation criteria in solid tumors version 1.1 (RECIST v1.1).
Measured: Up to approximately 30 months
Disease control rate (DCR)
To obtain a preliminary evaluation of the anti-tumor activity of H002 when given orally as determined according to response evaluation criteria in solid tumors version 1.1 (RECIST v1.1).
Measured: Up to approximately 30 months
Duration of response (DOR)
To obtain a preliminary evaluation of the anti-tumor activity of H002 when given orally as determined according to response evaluation criteria in solid tumors version 1.1 (RECIST v1.1).
Measured: Up to approximately 30 months
Progression-free survival (PFS)
To obtain a preliminary evaluation of the anti-tumor activity of H002 when given orally as determined according to response evaluation criteria in solid tumors version 1.1 (RECIST v1.1).
Measured: Up to approximately 30 months
Time to progression (TTP)
To obtain a preliminary evaluation of the anti-tumor activity of H002 when given orally as determined according to response evaluation criteria in solid tumors version 1.1 (RECIST v1.1).
Measured: Up to approximately 30 months
Overall survival (OS)
To obtain a preliminary evaluation of the anti-tumor activity of H002 when given orally as determined according to response evaluation criteria in solid tumors version 1.1 (RECIST v1.1).
Measured: Up to approximately 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start26 Aug 2022
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Dose-escalation and Expansion
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RedCloud Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- R&G Pharma Studies Co.,Ltd.
- Responsible party
- Sponsor
- Investigators
- Zhen Tan, Study director, RedCloud Bio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05552781
- Sponsor's protocol ID
- H002-101CN
- Status last verified
- Apr 2024
- First submitted
- 19 Aug 2022
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa, Open-label, Dose-escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Preliminary Anti-tumor Activity of H002 in Patients With EGFR Mutation Locally Advanced or Metastatic NSCLC
- ClinicalTrials.gov ID
- NCT05552781
- Acronym / sponsor ID
- H002-101CN
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- RedCloud BioIndustry (pharma, biotech, devices)
- Collaborators
- R&G Pharma Studies Co.,Ltd.
- Study start
- 26 Aug 2022 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 23 Sep 2022 (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 is a phase I/IIa, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, PK and preliminary anti-tumor activity of H002 when given orally in patients with EGFR mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).
The study will contain two parts: Part A is dose escalation phase (i.e., Phase I) and Part B is dose expansion phase (i.e., Phase IIa).
Detailed description
Part A (Dose Escalation Phase) Approximately 36 subjects will be enrolled, based on the "3+3" design for dose escalation and safety evaluation requirements. The total number of subjects will depend upon the number of dose escalations necessary.
Part B (Dose Expansion Phase) Up to 20 subjects will be enrolled in each expansion arm, the total number of subjects will depend upon the number of dose expansions (expansions may be at more than one dose depending upon emerging data).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Dose-escalation and Expansion
| Arm | Type | Receives |
|---|---|---|
| 20 mg QD, oral | Experimental | Drug: H002 capsuleH002 20mg QD, orally administered in fasting state, receive a single dose of H002 orally, followed by a 4-day washout period. Then, the same dose of H002 will be administered QD until disease progression or not tolerated. |
| 40 mg QD, oral | Experimental | Drug: H002 capsuleH002 40mg QD, orally administered in fasting state, receive a single dose of H002 orally, followed by a 4-day washout period. Then, the same dose of H002 will be administered QD until disease progression or not tolerated. |
| 80 mg QD, oral | Experimental | Drug: H002 capsuleH002 80mg QD, orally administered in fasting state, receive a single dose of H002 orally, followed by a 4-day washout period. Then, the same dose of H002 will be administered QD until disease progression or not tolerated. |
| 150 mg QD, ora | Experimental | Drug: H002 capsuleH002 150mg QD, orally administered in fasting state, receive a single dose of H002 orally, followed by a 4-day washout period. Then, the same dose of H002 will be administered QD until disease progression or not tolerated. |
| 250 mg QD, oral | Experimental | Drug: H002 capsuleH002 250mg QD, orally administered in fasting state, receive a single dose of H002 orally, followed by a 4-day washout period. Then, the same dose of H002 will be administered QD until disease progression or not tolerated. |
| 350 mg QD, oral | Experimental | Drug: H002 capsuleH002 350mg QD, orally administered in fasting state, receive a single dose of H002 orally, followed by a 4-day washout period. Then, the same dose of H002 will be administered QD until disease progression or not tolerated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Males or females aged ≥ 18 years at time of signing informed consent form (ICF).
- Histological or cytological confirmed diagnosis of unresectable locally advanced or metastatic NSCLC.
- Subjects must have NSCLC harboring one or more active EGFR mutations known to be associated with EGFR-TKI sensitivity (including, but not limited to Del19 and L858R).
- Note: Tumor sample can be either an archival sample or a sample obtained by pretreatment biopsy prior to H002 treatment.
- • Part A: Subjects have received the best treatment available as determined by the physician and must have radiological documented disease progression on the last treatment administered prior to enrolling in the study.
Key exclusion criteria (26 listed)
- Treatment with any of the following:
- Prior treatment with an EGFR-TKI within 8 days or approximately 5 × t1/2 prior to the first dose of H002, whichever is longer; Prior treatment with immunotherapy or biotherapy within 4 weeks prior to the first dose of H002; Radiotherapy (palliative radiotherapy is completed at least 2 weeks prior to the first dose of H002 can be enrolled) within 4 weeks prior to the first dose of H002; Herbal therapy that has anti-tumor effects within 2 weeks prior to the first dose of H002; Mitomycin and nitrosourea within 6 weeks prior to the first dose of H002; Oral fluorouracil such as tegafur and capecitabine within 2 weeks prior to the first dose of H002; Chemotherapy (except for mitomycin, nitrosourea, and fluorouracil oral drugs), or other anti-tumor drugs for the treatment of NSCLC within 4 weeks or approximately 5 × t1/2 prior to the first dose of H002, whichever is longer.
- Subjects with EGFR exon 20 insertion mutations only.
- Prior marketed and/or investigational treatment for EGFR C797S mutation (including, but not limited to BTP-661411, TQB3804 and BLU-945).
- Is currently participating and receiving investigational therapy or using an investigational device, or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks or 5 × t1/2 of the investigational product, whichever is longer, prior to the first dose of H002.
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 |
|---|---|---|
| H002 capsuleAlso: H002Small molecule, Capsule | Drug | 150 mg QD, ora, 20 mg QD, oral, 250 mg QD, oral, 350 mg QD, oral, 40 mg QD, oral, 80 mg QD, oral |
Primary outcome
DOSE ESCALATION PHASE：Incidence of dose-limiting toxicities (DLTs) at Cycle 0 and Cycle1. Incidence and severity of treatment-emergent adverse events (TEAEs), with severity determined according to National Cancer Institute (NCI) CTCAE v5.0.
Time frame: At the end of Cycle 1 (include 4 days in Cycle 0 and 21 days in Cycle1)
To evaluate the safety and tolerability of H002 and to determine the maximal tolerable dose (MTD), or if possible, a dose/exposure predicted to result in optimal biological dose (OBD) or recommended phase II dose (RP2D).
DOSE EXPANSION PHASE：Objective Response Rate (ORR)
Time frame: [Time Frame: Up to approximately 30 months]
To obtain a preliminary evaluation of the anti-tumor activity at the selected dose(s) of H002 when given orally as determined according to RECIST v1.1.
DOSE EXPANSION PHASE：To evaluate the incidence and severity of TEAEs, with severity determined according to NCI CTCAE v5.0.
Time frame: Up to approximately 30 months
To evaluate the safety at the selected dose(s) of H002 when given orally.
10 secondary outcomes
Peak Plasma Concentration (Cmax)
Time frame: Up to approximately 30 months
Time to reach maximum concentration (Tmax)
Time frame: Up to approximately 30 months
Area under the plasma concentration versus time curve (AUC)
Time frame: Up to approximately 30 months
Time for half the drug concentration to be eliminated（t1/2）
Time frame: Up to approximately 30 months
DOSE ESCALATION PHASE：Objective Response Rate (ORR)
Time frame: Up to approximately 30 months
Disease control rate (DCR)
Time frame: Up to approximately 30 months
Duration of response (DOR)
Time frame: Up to approximately 30 months
Progression-free survival (PFS)
Time frame: Up to approximately 30 months
Time to progression (TTP)
Time frame: Up to approximately 30 months
Overall survival (OS)
Time frame: Up to approximately 30 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- 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.
Zhen Tan study director
RedCloud Bio
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing H002 capsule in people with Non-small Cell Lung Cancer, run by RedCloud Bio at 8 sites 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 14 inclusion and 26 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 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Yuying He (+86 10 88018650, yuying.he@rg-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DOSE ESCALATION PHASE：Incidence of dose-limiting toxicities (DLTs) at Cycle 0 and Cycle1. Incidence and severity of treatment-emergent adverse events (TEAEs), with severity determined according to National Cancer Institute (NCI) CTCAE v5.0. (time frame: At the end of Cycle 1 (include 4 days in Cycle 0 and 21 days in Cycle1)). 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 11 Apr 2024.