Advanced Solid TumorsPhase 1NCT06882135
HW071021 Monotherapy in Patients With Advanced Solid Tumors
A Phase 1 study testing HW071021 Tablets in people with Advanced Solid Tumors, run by Wuhan Humanwell Innovative Drug Research and Development Center Limited Company at 1 site in China.
Trial summary
This is a Phase I open-label study that will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HW071021 monotherapy in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- HW071021 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 28 May 2025to 28 Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Age of 18 years or older, applicable to both males and females.
- Patients with histologically and/or cytologically confirmed recurrent and/or metastatic advanced solid tumors, mainly covering non - small cell lung cancer, colorectal cancer, pancreatic cancer, cholangiocarcinoma, and other cancer types that investigators believe may bring benefits. The selection of cancer types in the dose - expansion phase will be decided based on the data from the dose - escalation phase.
- No standard treatment is accessible, standard treatment has failed, or the patient is not suitable for standard treatment.
- The expected survival time is ≥ 12 weeks.
- Participant must have adequate main organ function.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score is 0 or 1.
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- According to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, there is at least one measurable target lesion.
- Participants who are capable of having children must agree to use two medically approved effective contraceptive methods during the study and for 6 months after the last dose. Women of childbearing age must have a negative serum pregnancy test within 7 days before dosing.
- Have a full understanding of this study, voluntarily sign the informed consent form, and be able to follow the study's operating procedures and requirements for follow - up examinations.
Who cannot join
- Known allergy to the investigational drug, drugs with the same mechanism of action or excipients.
- Prior treatment with drugs targeting the same molecular target.
- Use of other investigational drugs within 28 days before the first dose or at least 5 half - lives of the respective drug (whichever is shorter).
- Receipt of surgery, chemotherapy, radiotherapy, targeted therapy, endocrine therapy, biological therapy, immunotherapy, anti - tumor herbal medicine, or other anti - cancer treatments within 28 days before the first dose or at least 5 half - lives of the respective drug (whichever is shorter).
- Use of any drugs likely to interfere with trial safety within 2 weeks before dosing or at least 5 half - lives of the respective drug (whichever is shorter), and planned use during the study, including strong inhibitors/inducers of hepatic metabolic enzymes and P - gp, or substrates of hepatic metabolic enzymes with narrow therapeutic indices.
- Undergoing major surgery within 28 days before the first dose.
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- Presence of ≥ Grade 2 toxicity from prior anti - cancer treatment (per Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0), except for toxicities deemed non - safety - critical by the investigator (e.g., alopecia, pigmentation, specific laboratory abnormalities).
- Severe cardiovascular or cerebrovascular diseases.
- History of clinically significant QTc interval prolongation, or QTc interval > 470 ms in females and > 450 ms in males at screening.
- Uncontrolled/clinically symptomatic central nervous system metastases.
- Positive for hepatitis B surface antigen (HBsAg) (except for hepatocellular carcinoma patients) with HBV DNA > 1000 IU/mL; positive for hepatitis C virus (HCV) antibody with HCV RNA positive; positive for human immunodeficiency virus (HIV) antibody; or active syphilis (positive for both TPPA and RPR).
- Diagnosis of autoimmune disease, immunodeficiency disorder, history of organ transplantation, or planned organ transplantation.
- Inability to swallow oral formulations and/or gastrointestinal disorders that may interfere with drug absorption.
- Presence of any severe, uncontrolled clinical issues (e.g., uncontrolled malignant pleural effusion, ascites, pericardial effusion, or unstable psychiatric conditions) deemed unsuitable for study participation by the investigator.
- Any significant clinical or laboratory abnormalities affecting safety assessment, as determined by the investigator.
- Severe pulmonary diseases at screening, including pulmonary embolism, interstitial lung disease, active pulmonary infection, or other active infections deemed unsuitable for study entry by the investigator.
- History of alcohol abuse or substance dependence.
- Pregnant or lactating females, or females planning to become pregnant or breastfeed during the study.
- Other conditions deemed unsuitable for enrollment by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Li Zhang, Doctor, +86-20-87343458, zhangli@sysucc.org.cn
Li Zhang
About this study
Official title: A Phase I Open-Label, Dose-Escalation and Dose-Expansion Trial Evaluating Safety, Pharmacokinetics, and Efficacy of HW071021 in Patients With Advanced Solid Tumors
This is a Phase I open-label study that will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HW071021 monotherapy in patients with advanced solid tumors.
Read the detailed description
This trial is an open-label, dose-escalation/expansion first-in-human study of HW071021, divided into two phases:
Phase 1 (Dose Escalation): This phase plans to enroll patients with advanced solid tumors who have no standard treatment, have failed standard treatment, or are ineligible for standard treatment. Patients will receive oral monotherapy with HW071021 at pre-specified escalating doses (single-dose and continuous-dose administration). The objectives are to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HW071021 in patients. Selected subjects in Phase 1 will undergo a QT/QTc study to assess the drug's effects on QT/QTc intervals and cardiac safety.
Phase 2 (Dose Expansion): This phase intends to enroll patients with advanced solid tumors who have no standard treatment, have failed standard treatment, or are ineligible for standard treatment. Patients will receive continuous administration of HW071021 to provide additional clinical data for determining the Phase 2 recommended dose (P2RD) and potential indications.
- Conditions
- Advanced Solid Tumors
- Being tested
- HW071021 Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HW071021 TabletsDrug
Administered orally at pre-specified doses once or twice daily.
| Study group | Role | What they receive |
|---|---|---|
| HW071021 Dose Escalation | Experimental | Six dose levels were pre-specified, with a starting dose of 50 mg/day; subsequent levels may be adjusted based on pharmacokinetic (PK) and safety data. Receives: Drug: HW071021 Tablets |
| HW071021 Dose Expansion | Experimental | Based on the results of the dose escalation phase, 1-2 dose levels were selected. Receives: Drug: HW071021 Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Assessed by CTCAE v5.0
Measured: Up to 2 years
Secondary outcomes (10)
Pharmacokinetic Parameter：Maximum Plasma Concentration (Cmax）(Phase 1 only)
Measured: Up to 5 weeks
Pharmacokinetic Parameter：Area Under the Curve from Time 0 to the Last Quantifiable Data Point (AUC0-t）(Phase 1 only)
Measured: Up to 5 weeks
Pharmacokinetic Parameter：Area Under the Curve Over a Dosing Interval (AUCss,0-tau）(Phase 1 only)
Measured: Up to 2 years
Pharmacokinetic Parameter：Trough Concentration (Ctrough）
Measured: Up to 2 years
Number of patients with Dose-limiting Toxicities (DLTs) during the DLT assessment period(Phase 1 only)
Measured: Up to 5 weeks
Maximum tolerated dose (MTD) based on number of DLTs (Phase 1 only)
Measured: Up to 5 weeks
Phase II recommended dose
Measured: Up to 2 years
(C-ΔQTc) analysis (Phase 1 only)
Measured: Up to 2 years
Preliminary Efficacy：Objective Response Rate (ORR)
Measured: Up to 2 years
Preliminary Efficacy：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 posted18 Mar 2025
- Study start28 May 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion28 Feb 2027 (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.
- 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuhan Humanwell Innovative Drug Research and Development Center Limited Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li Zhang, Doctor, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882135
- Sponsor's protocol ID
- RFSO-2024-11
- Status last verified
- Dec 2025
- First submitted
- 7 Mar 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The decision not to share IPD is based on ethical and legal considerations to protect participant privacy and confidentiality. The trial involves sensitive data that, if de-identified, could still pose risks to participants in accordance with the Regulations of the People's Republic of China on the Administration of Human Genetic Resources. Additionally, the study protocol and informed consent form did not explicitly state that data would be shared beyond the trial team.
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open-Label, Dose-Escalation and Dose-Expansion Trial Evaluating Safety, Pharmacokinetics, and Efficacy of HW071021 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06882135
- Acronym / sponsor ID
- RFSO-2024-11
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Wuhan Humanwell Innovative Drug Research and Development Center Limited CompanyIndustry (pharma, biotech, devices)
- Study start
- 28 May 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 18 Mar 2025 (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 open-label study that will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HW071021 monotherapy in patients with advanced solid tumors.
Detailed description
This trial is an open-label, dose-escalation/expansion first-in-human study of HW071021, divided into two phases:
Phase 1 (Dose Escalation): This phase plans to enroll patients with advanced solid tumors who have no standard treatment, have failed standard treatment, or are ineligible for standard treatment. Patients will receive oral monotherapy with HW071021 at pre-specified escalating doses (single-dose and continuous-dose administration). The objectives are to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HW071021 in patients. Selected subjects in Phase 1 will undergo a QT/QTc study to assess the drug's effects on QT/QTc intervals and cardiac safety.
Phase 2 (Dose Expansion): This phase intends to enroll patients with advanced solid tumors who have no standard treatment, have failed standard treatment, or are ineligible for standard treatment. Patients will receive continuous administration of HW071021 to provide additional clinical data for determining the Phase 2 recommended dose (P2RD) and potential indications.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HW071021 Dose Escalation | Experimental | Drug: HW071021 TabletsSix dose levels were pre-specified, with a starting dose of 50 mg/day; subsequent levels may be adjusted based on pharmacokinetic (PK) and safety data. |
| HW071021 Dose Expansion | Experimental | Drug: HW071021 TabletsBased on the results of the dose escalation phase, 1-2 dose levels were selected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age of 18 years or older, applicable to both males and females.
- Patients with histologically and/or cytologically confirmed recurrent and/or metastatic advanced solid tumors, mainly covering non - small cell lung cancer, colorectal cancer, pancreatic cancer, cholangiocarcinoma, and other cancer types that investigators believe may bring benefits. The selection of cancer types in the dose - expansion phase will be decided based on the data from the dose - escalation phase.
- No standard treatment is accessible, standard treatment has failed, or the patient is not suitable for standard treatment.
- The expected survival time is ≥ 12 weeks.
- Participant must have adequate main organ function.
Key exclusion criteria (19 listed)
- Known allergy to the investigational drug, drugs with the same mechanism of action or excipients.
- Prior treatment with drugs targeting the same molecular target.
- Use of other investigational drugs within 28 days before the first dose or at least 5 half - lives of the respective drug (whichever is shorter).
- Receipt of surgery, chemotherapy, radiotherapy, targeted therapy, endocrine therapy, biological therapy, immunotherapy, anti - tumor herbal medicine, or other anti - cancer treatments within 28 days before the first dose or at least 5 half - lives of the respective drug (whichever is shorter).
- Use of any drugs likely to interfere with trial safety within 2 weeks before dosing or at least 5 half - lives of the respective drug (whichever is shorter), and planned use during the study, including strong inhibitors/inducers of hepatic metabolic enzymes and P - gp, or substrates of hepatic metabolic enzymes with narrow therapeutic indices.
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 |
|---|---|---|
| HW071021 TabletsAdministered orally at pre-specified doses once or twice daily. | Drug | HW071021 Dose Escalation, HW071021 Dose Expansion |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: Up to 2 years
Assessed by CTCAE v5.0
10 secondary outcomes
Pharmacokinetic Parameter：Maximum Plasma Concentration (Cmax）(Phase 1 only)
Time frame: Up to 5 weeks
Pharmacokinetic Parameter：Area Under the Curve from Time 0 to the Last Quantifiable Data Point (AUC0-t）(Phase 1 only)
Time frame: Up to 5 weeks
Pharmacokinetic Parameter：Area Under the Curve Over a Dosing Interval (AUCss,0-tau）(Phase 1 only)
Time frame: Up to 2 years
Pharmacokinetic Parameter：Trough Concentration (Ctrough）
Time frame: Up to 2 years
Number of patients with Dose-limiting Toxicities (DLTs) during the DLT assessment period(Phase 1 only)
Time frame: Up to 5 weeks
Maximum tolerated dose (MTD) based on number of DLTs (Phase 1 only)
Time frame: Up to 5 weeks
Phase II recommended dose
Time frame: Up to 2 years
(C-ΔQTc) analysis (Phase 1 only)
Time frame: Up to 2 years
Preliminary Efficacy：Objective Response Rate (ORR)
Time frame: Up to 2 years
Preliminary Efficacy：Progression-Free Survival (PFS)
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: No. The decision not to share IPD is based on ethical and legal considerations to protect participant privacy and confidentiality. The trial involves sensitive data that, if de-identified, could still pose risks to participants in accordance with the Regulations of the People's Republic of China on the Administration of Human Genetic Resources. Additionally, the study protocol and informed consent form did not explicitly state that data would be shared beyond the trial team.
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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.
Li Zhang, Doctor principal investigator
Sun Yat-Sen University Cancer Center
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 HW071021 Tablets in people with Advanced Solid Tumors, run by Wuhan Humanwell Innovative Drug Research and Development Center Limited Company 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 9 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 29 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Medical Affairs Department (+86-27-87171183, medicalaffairs@renfu.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: Up to 2 years). 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 29 Dec 2025.