Advanced Solid TumorsPhase 1NCT04325711
A Study of CSPCHA131 in Patients With Advanced Solid Tumor
A Phase 1 study testing CSPCHA131 in people with Advanced Solid Tumors, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
The study was designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of CSPCHA131 alone or plus chemotherapy in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- CSPCHA131
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 24 Apr 2020to 12 Apr 2021
- 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
- 1.18-75 years of age.
- 2. Histologically or cytologically confirmed diagnosis of advanced or metastatic malignant solid tumors, for which standard therapy either does not exist or has been proven ineffective or intolerable for the patient.
- 3. At least one measurable tumor lesion according to RECIST version 1.1.
- 4. ECOG performance status of 0 or 1.
- 5. Life expectancy ≥ 3 months. No cardiac insufficiency or serious abnormalities in the electrocardiogram at baseline.
Who cannot join
- 1. Administration of chemotherapy, radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy, other anti-tumor treatments or an investigational drug within 4 weeks or 5 half-lives, whichever is longer, preceding the first dose of study treatment.
- 2. Have undergone surgery within 4 weeks prior to the study treatment or have not fully recovered from any previous invasive procedure.
- 3. Adverse reactions to previous anti-tumor treatments that levels have not recovered to grade 1 or less.
- 4. Patients with evidence of uncontrolled nervous system metastasis or meningeal metastases, in the opinion of the investigator, not suitable for enrollment.
- 5. Active infections of grade 2 or above.
- 6. Peripheral neuropathy of grade 2 or above.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai
Xichun Hu
About this study
Official title: A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of CSPCHA131 in Patients With Advanced Solid Tumors
The study was designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of CSPCHA131 alone or plus chemotherapy in patients with advanced solid tumors.
Read the detailed description
This is a dose escalation and expansion study with the aim to evaluate and characterize the tolerability and safety profile of CSPCHA131 alone (Stage I) or plus chemotherapy (Stage II) in patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- CSPCHA131
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSPCHA131Drug
CSPCHA131 will be administered twice weekly in the first three weeks of a 4-week cycle.
| Study group | Role | What they receive |
|---|---|---|
| CSPCH131 dose Escalation and expansion | Experimental | In the dose escalation part of Stage I, five dose levels will be tested according to the "3 + 3" dose-escalation design. Whether and how to carry out the follow-up study parts will be decided by the PI and sponsor on the basis of the achieved results of safety, tolerability and effectiveness of CSPCHA131. Receives: Drug: CSPCHA131 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) and incidence of dose limiting toxicity (DLT) within the first cycle at each dose level.
Measured: Time Frame: 28 days
Incidence of adverse events (AEs) and serious adverse events throughout the trial;
Measured: from enrollment to the end of the trial (2 years)
Secondary outcomes (13)
Objective response rate (ORR) defined by RECIST Criteria Version 1.1;
ORR is defined as the proportion of patients who achieve complete response (CR) or partial response (PR).
Measured: from enrollment to the end of the trial (2 years)
Progression free survival (PFS) defined by RECIST Criteria Version 1.1;
PFS is defined as the time from the start of treatment until disease progression or death from any cause, whichever is earlier.
Measured: from enrollment to the end of the trial (2 years)
AUC0-t
PK parameter: AUC0-t
Measured: 28 days
AUC0-∞
PK parameter: AUC0-∞
Measured: 28 days
Cmax
PK parameter: Cmax
Measured: 28 days
Css_max
PK parameter: Css_max
Measured: 28 days
Css_min
PK parameter: Css_min
Measured: 28 days
DF
PK parameter: DF
Measured: 28 days
Ke
PK parameter: Ke
Measured: 28 days
Tmax
PK parameter: Tmax
Measured: 28 days
Vz
PK parameter: Vz
Measured: 28 days
T1/2
PK parameter: T1/2
Measured: 28 days
CL
PK parameter: CL
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start24 Apr 2020
- Primary completion12 Apr 2021 (estimated)
- Study completion12 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04325711
- Sponsor's protocol ID
- CSPCHA131-CSP-001
- Status last verified
- Mar 2020
- First submitted
- 10 Mar 2020
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of CSPCHA131 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04325711
- Acronym / sponsor ID
- CSPCHA131-CSP-001
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Apr 2020 (actual)
- Primary completion
- 12 Apr 2021 (estimated)
- Study completion
- 12 Apr 2021 (estimated)
- First posted
- 30 Mar 2020 (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 was designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of CSPCHA131 alone or plus chemotherapy in patients with advanced solid tumors.
Detailed description
This is a dose escalation and expansion study with the aim to evaluate and characterize the tolerability and safety profile of CSPCHA131 alone (Stage I) or plus chemotherapy (Stage II) in patients with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CSPCH131 dose Escalation and expansion | Experimental | Drug: CSPCHA131In the dose escalation part of Stage I, five dose levels will be tested according to the "3 + 3" dose-escalation design. Whether and how to carry out the follow-up study parts will be decided by the PI and sponsor on the basis of the achieved results of safety, tolerability and effectiveness of CSPCHA131. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1.18-75 years of age.
- 2. Histologically or cytologically confirmed diagnosis of advanced or metastatic malignant solid tumors, for which standard therapy either does not exist or has been proven ineffective or intolerable for the patient.
- 3. At least one measurable tumor lesion according to RECIST version 1.1.
- 4. ECOG performance status of 0 or 1.
- 5. Life expectancy ≥ 3 months. No cardiac insufficiency or serious abnormalities in the electrocardiogram at baseline.
Key exclusion criteria (6 listed)
- 1. Administration of chemotherapy, radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy, other anti-tumor treatments or an investigational drug within 4 weeks or 5 half-lives, whichever is longer, preceding the first dose of study treatment.
- 2. Have undergone surgery within 4 weeks prior to the study treatment or have not fully recovered from any previous invasive procedure.
- 3. Adverse reactions to previous anti-tumor treatments that levels have not recovered to grade 1 or less.
- 4. Patients with evidence of uncontrolled nervous system metastasis or meningeal metastases, in the opinion of the investigator, not suitable for enrollment.
- 5. Active infections of grade 2 or above.
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 |
|---|---|---|
| CSPCHA131CSPCHA131 will be administered twice weekly in the first three weeks of a 4-week cycle. | Drug | CSPCH131 dose Escalation and expansion |
Primary outcome
Maximum tolerated dose (MTD) and incidence of dose limiting toxicity (DLT) within the first cycle at each dose level.
Time frame: Time Frame: 28 days
Incidence of adverse events (AEs) and serious adverse events throughout the trial;
Time frame: from enrollment to the end of the trial (2 years)
13 secondary outcomes
Objective response rate (ORR) defined by RECIST Criteria Version 1.1;
Time frame: from enrollment to the end of the trial (2 years)
Progression free survival (PFS) defined by RECIST Criteria Version 1.1;
Time frame: from enrollment to the end of the trial (2 years)
AUC0-t
Time frame: 28 days
AUC0-∞
Time frame: 28 days
Cmax
Time frame: 28 days
Css_max
Time frame: 28 days
Css_min
Time frame: 28 days
DF
Time frame: 28 days
Ke
Time frame: 28 days
Tmax
Time frame: 28 days
Vz
Time frame: 28 days
T1/2
Time frame: 28 days
CL
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
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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.
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 CSPCHA131 in people with Advanced Solid Tumors, run by CSPC ZhongQi Pharmaceutical Technology 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 6 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 6 Jan 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiugao Yang (+86 02160677906, yangxiugao@mail.ecspc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) and incidence of dose limiting toxicity (DLT) within the first cycle at each dose level. (time frame: Time Frame: 28 days). 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 6 Jan 2021; AzTrials last refreshed its copy on 6 Nov 2026.