Advanced Solid TumorPhase 1NCT03994484
Study of Dosage Exploration and Pharmacokinetics for HA121-28 Tablets
A Phase 1 study testing HA121-28 tablets in people with Advanced Solid Tumor, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
There are 2 phases in this study: Phase 1 (dose escalation) and Phase 2 (dose expansion). The goal of Phase 1 of this clinical research study is to find the highest tolerable dose of HA121-28 tablets that can be given to patients with advanced cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- HA121-28 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2018to 30 Dec 2022
- 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
- Be willing to participate in the clinical trial and sign the informed consent;
- Men and women aged 18 to 75 years;
- Histologically/cytologically confirmed advanced/metastatic solid tumor, and have failed prior standard therapy or for which no standard therapy is durable(patients with RET fusion/mutation can be included regardless of whether they have received standard therapy or not);
- At least one measurable lesion according to RECIST 1.1 ;
- Subject has not received any anti-cancer therapies including chemotherapy, radiotherapy, targeted treatment and surgery within 4 weeks prior to participation;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1;
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- Expected overall survival (Life expectancy)≥ 3 months;
- Laboratory test results must meet the following standards:
- Absolute neutrophil count (ANC) ≥1.5 x 10^9/L; Platelet count (PLT) ≥75×10^9/L; Hemoglobin (Hb) ≥90 g/L (no blood transfusion within 14 days); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 x upper limit of normal (ULN) (in patients with liver metastasis ≤5.0 x ULN); Total bilirubin ≤ 1.5 x ULN; Serum creatinine≤ 1.5 x ULN；
- Male and female subjects of childbearing potential should agree to use suitable method of contraception during the treatment and 6 months after the last dose of study medication; female participants should have negative results of serum/urine pregnancy test within 7 days prior to enrollment and cannot be breastfeeding.
Who cannot join
- Has participated in other clinical trials and received the treatment within 4 weeks prior to enrollment;
- Patients who cannot swallow or have chronic diarrhea and intestinal obstruction, which may affect the administration and absorption of the drug;
- Subject who meets one of the following criteria:
- Corrected QT (QTc) ≥470ms in women, ≥450ms in men; or congenital long QT syndrome (LQTS), taking QT prolonging medications, and has a family history of long QT syndrome;
- Resting ECG result shows clinically significant abnormalities of rhythm, conduction or morphology, requiring therapeutic intervention;
- Urinalysis result shows protein in urine ≥ ++ and 24-hour urine protein > 1.0g;
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- Based on the investigator's assessment, patients with known severe comorbidities which may influence the safety of the patients and the study completion [such as uncontrolled hypertension (systolic pressure ≥150 mmHg or diastolic pressure ≥100 mmHg, despite treated with the optimal medicine), diabetes, etc.];
- Patients who have symptoms of metastatic brain/meningeal tumors within 4 weeks of participation;
- Ongoing adverse events>grade 1 at the time of participation (except hair loss and pigmentation);
- Patients who have undergone major surgery or have not recovered from Invasive operation within 4 weeks prior to initiation of study treatment;
- Coagulation disorders (INR >1.5, prothrombin time (PT) > ULN+4s or APTT >1.5ULN): with bleeding diathesis (such as active peptic ulcer) or receiving thrombolytic or anti-coagulant treatment;
- Known pulmonary infection/ pneumonitis / interstitial pneumonia who are not suitable for the research;
- Known active Hepatitis B or Hepatitis C virus infection;
- if HBsAg result is positive, additional HBV DNA testing is required (the result is higher than the ULN of the research center);
- if HCV antibody result is positive, additional HCV RNA testing is required (the result is higher than the ULN of the research center);
- Known history of human immunodeficiency virus (HIV), or other acquired/congenital immune deficiency diseases or organ transplantation;
- Other anti-tumor therapies are required (including radiotherapy, chemotherapy, immunotherapy, targeted treatment, traditional Chinese medicine, etc.);
- Patients with known history of neurological or psychiatric disorders, including epilepsy or dementia;
- Not suitable for the treatment assessed by the researchers;
- Cardiac ejection fraction less than 50%;
- Patients who have suffered from or are complicated with any other malignant tumor within 5 years (except radically resected skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, local prostate cancer, in situ cervical cancer or other carcinoma in situ).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000
Xu
About this study
Official title: Pharmacokinetics of Single and Multiple Doses of HA121-28 Tablets and Exploration of Maximum Tolerated Dose in Patients With Advanced Solid Tumor in PhaseⅠClinical Trial
There are 2 phases in this study: Phase 1 (dose escalation) and Phase 2 (dose expansion).
The goal of Phase 1 of this clinical research study is to find the highest tolerable dose of HA121-28 tablets that can be given to patients with advanced cancer. The goal of Phase 2 of this study is to learn if the dose of HA121-28 tablets found in Phase 1 can help to control advanced cancer.
The safety of HA121-28 tablets will be studied in both phases of the study.
Read the detailed description
If participants are found to be eligible to take part in this study, they will be assigned to a study group based on when they join this study. Up to 8 groups of up to 20 participants will be enrolled in Phase 1 of the study, and up to 3 groups of up to 24 participants will be enrolled in Phase 2.
If participant is enrolled in Phase 1, the dose of HA121-28 tablets they receive will depend on when they join this study. The first group of participants will receive the lowest dose level of HA121-28 tablets. Each new group will receive a higher dose of HA121-28 tablets than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of HA121-28 tablets is found. If participant is enrolled in Phase 2, they will receive HA121-28 tablets at the low, medium and high doses to select the recommended dose for phase Ⅱ clinical trials.
- Conditions
- Advanced Solid Tumor
- Being tested
- HA121-28 tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HA121-28 tabletsDrug
Participants will receive oral HA121-28 at a starting dose of 25 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle
HA121-28 tabletsDrug
Participants will receive oral HA121-28 at a dose of 50 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle
HA121-28 tabletsDrug
Participants will receive oral HA121-28 at a dose of 100 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle
HA121-28 tabletsDrug
Participants will receive oral HA121-28 at a dose of 200 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle
HA121-28 tabletsDrug
Participants will receive oral HA121-28 at a dose of 300 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle
HA121-28 tabletsDrug
Participants will receive oral HA121-28 at a dose of 450 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle
HA121-28 tabletsDrug
Participants will receive oral HA121-28 at a dose of 600 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle
HA121-28 tabletsDrug
Participants will receive oral HA121-28 at a dose of 800 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle
| Study group | Role | What they receive |
|---|---|---|
| HA121-28 tables | Experimental | Participants will receive oral HA121-28 at a starting dose of 25 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle Receives: Drug: HA121-28 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of HA121-28 tablets in Advanced and/or Metastatic Cancer Refractory to Standard Treatment
MTD defined by dose limiting toxicities (DLTs) that occur in the first cycle. DLT defined as any clinically grade 3 or 4 non-hematologic toxicity as defined in the NCI CTC v4.0
Measured: At the end of Cycle 1 (each cycle is 28 days)
Secondary outcomes (1)
Antitumor Efficacy of HA121-28 tablets: RECIST criteria version 1.1.
Efficacy evaluation done using RECIST criteria version 1.1.
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start10 Oct 2018
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wen Xu, Study director, Clinical Medicine Department CSPC R&D Business Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03994484
- Sponsor's protocol ID
- HA121-28/2017/01
- Status last verified
- Feb 2022
- First submitted
- 18 Jun 2019
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ruan DY, Huang WW, Li Y, Zhao Y, Shi Y, Jia Y, Cang S, Zhang W, Shi J, Chen J, Lin J, Liu Y, Xu J, Ouyang W, Fang J, Zhuang W, Liu C, Bu Q, Li M, Meng X, Sun M, Yang N, Dong X, Pan Y, Li X, Qu X, Zhang T, Yuan X, Hu S, Guo W, Li Y, Li S, Liu D, Song F, Tan L, Yu Y, Yu X, Zang A, Sun C, Zhang Q, Zou K, Dan M, Xu RH, Zhao H. Safety, pharmacokinetics and efficacy of HA121-28 in patients with advanced solid tumors and RET fusion-positive non-small-cell lung cancer: a multicenter, open-label, single-arm phase 1/2 trial. Signal Transduct Target Ther. 2025 Feb 28;10(1):62. doi: 10.1038/s41392-025-02155-5.
PubMed 40016191
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Single and Multiple Doses of HA121-28 Tablets and Exploration of Maximum Tolerated Dose in Patients With Advanced Solid Tumor in PhaseⅠClinical Trial
- ClinicalTrials.gov ID
- NCT03994484
- Acronym / sponsor ID
- HA121-28/2017/01
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 21 Jun 2019 (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.
There are 2 phases in this study: Phase 1 (dose escalation) and Phase 2 (dose expansion).
The goal of Phase 1 of this clinical research study is to find the highest tolerable dose of HA121-28 tablets that can be given to patients with advanced cancer. The goal of Phase 2 of this study is to learn if the dose of HA121-28 tablets found in Phase 1 can help to control advanced cancer.
The safety of HA121-28 tablets will be studied in both phases of the study.
Detailed description
If participants are found to be eligible to take part in this study, they will be assigned to a study group based on when they join this study. Up to 8 groups of up to 20 participants will be enrolled in Phase 1 of the study, and up to 3 groups of up to 24 participants will be enrolled in Phase 2.
If participant is enrolled in Phase 1, the dose of HA121-28 tablets they receive will depend on when they join this study. The first group of participants will receive the lowest dose level of HA121-28 tablets. Each new group will receive a higher dose of HA121-28 tablets than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of HA121-28 tablets is found. If participant is enrolled in Phase 2, they will receive HA121-28 tablets at the low, medium and high doses to select the recommended dose for phase Ⅱ clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HA121-28 tables | Experimental | Drug: HA121-28 tabletsParticipants will receive oral HA121-28 at a starting dose of 25 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Be willing to participate in the clinical trial and sign the informed consent;
- Men and women aged 18 to 75 years;
- Histologically/cytologically confirmed advanced/metastatic solid tumor, and have failed prior standard therapy or for which no standard therapy is durable(patients with RET fusion/mutation can be included regardless of whether they have received standard therapy or not);
- At least one measurable lesion according to RECIST 1.1 ;
- Subject has not received any anti-cancer therapies including chemotherapy, radiotherapy, targeted treatment and surgery within 4 weeks prior to participation;
Key exclusion criteria (21 listed)
- Has participated in other clinical trials and received the treatment within 4 weeks prior to enrollment;
- Patients who cannot swallow or have chronic diarrhea and intestinal obstruction, which may affect the administration and absorption of the drug;
- Subject who meets one of the following criteria:
- Urinalysis result shows protein in urine ≥ ++ and 24-hour urine protein > 1.0g;
- Based on the investigator's assessment, patients with known severe comorbidities which may influence the safety of the patients and the study completion [such as uncontrolled hypertension (systolic pressure ≥150 mmHg or diastolic pressure ≥100 mmHg, despite treated with the optimal medicine), diabetes, etc.];
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 |
|---|---|---|
| HA121-28 tabletsParticipants will receive oral HA121-28 at a starting dose of 25 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle | Drug | HA121-28 tables |
| HA121-28 tabletsParticipants will receive oral HA121-28 at a dose of 50 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle | Drug | HA121-28 tables |
| HA121-28 tabletsParticipants will receive oral HA121-28 at a dose of 100 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle | Drug | HA121-28 tables |
| HA121-28 tabletsParticipants will receive oral HA121-28 at a dose of 200 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle | Drug | HA121-28 tables |
| HA121-28 tabletsParticipants will receive oral HA121-28 at a dose of 300 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle | Drug | HA121-28 tables |
| HA121-28 tabletsParticipants will receive oral HA121-28 at a dose of 450 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle | Drug | HA121-28 tables |
| HA121-28 tabletsParticipants will receive oral HA121-28 at a dose of 600 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle | Drug | HA121-28 tables |
| HA121-28 tabletsParticipants will receive oral HA121-28 at a dose of 800 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle | Drug | HA121-28 tables |
Primary outcome
Maximum Tolerated Dose (MTD) of HA121-28 tablets in Advanced and/or Metastatic Cancer Refractory to Standard Treatment
Time frame: At the end of Cycle 1 (each cycle is 28 days)
MTD defined by dose limiting toxicities (DLTs) that occur in the first cycle. DLT defined as any clinically grade 3 or 4 non-hematologic toxicity as defined in the NCI CTC v4.0
1 secondary outcome
Antitumor Efficacy of HA121-28 tablets: RECIST criteria version 1.1.
Time frame: up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
- Derived from this study: PubMed 40016191Ruan DY, Huang WW, Li Y, Zhao Y, Shi Y, Jia Y, Cang S, Zhang W, Shi J, Chen J, Lin J, Liu Y, Xu J, Ouyang W, Fang J, Zhuang W, Liu C, Bu Q, Li M, Meng X, Sun M, Yang N, Dong X, Pan Y, Li X, Qu X, Zhang T, Yuan X, Hu S, Guo W, Li Y, Li S, Liu D, Song F, Tan L, Yu Y, Yu X, Zang A, Sun C, Zhang Q, Zou K, Dan M, Xu RH, Zhao H. Safety, pharmacokinetics and efficacy of HA121-28 in patients with advanced solid tumors and RET fusion-positive non-small-cell lung cancer: a multicenter, open-label, single-arm phase 1/2 trial. Signal Transduct Target Ther. 2025 Feb 28;10(1):62. doi: 10.1038/s41392-025-02155-5.
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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.
Wen Xu study director
Clinical Medicine Department CSPC R&D Business Division
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 HA121-28 tablets in people with Advanced Solid Tumor, 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 10 inclusion and 21 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 10 Feb 2022. 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 Wen Xu (1850063169, xuwen@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) of HA121-28 tablets in Advanced and/or Metastatic Cancer Refractory to Standard Treatment (time frame: At the end of Cycle 1 (each cycle is 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03994484, which also lists 1 linked publication.
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 10 Feb 2022.