Advanced Solid TumorsPhase 1NCT07377591
A Study of HDM2006 in Patients With Advanced Solid Tumor
A Phase 1 study testing HDM2006 in people with Advanced Solid Tumors, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a first-in-human (FIH) study to evaluate the safety and preliminary efficacy of experimental drug HDM2006 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?
- HDM2006
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2024to Mar 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
- 1. The subjects understand and voluntarily (or legally authorized guardian) sign a written informed consent form (ICF) approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
- 2. Males or females aged ≥ 18 years old. 3. In the dose escalation phase, subjects must have histologically or cytologically confirmed advanced or metastatic solid tumors, who have experienced adequate standard treatment failure, intolerance to standard treatment, or lack of effective standard treatment.
- 4. In the dose expansion phase, subjects must have histologically or cytologically confirmed advanced or metastatic specific types of tumors, who have experienced adequate standard treatment failure, intolerance to standard treatment, or lack of effective standard treatment. These include, but are not limited to, head and neck squamous cell carcinoma, renal cell carcinoma, cervix carcinoma, and other advanced solid tumors, as well as tumor types that showed efficacy signals (CR/PR) in the dose escalation phase.
- 5. In the dose expansion phase, subjects are able to provide fresh or archival (within one year) tumor tissues at the time of screening and are willing to provide tumor tissue biopsy after administration of HDM2006 for baseline and post-treatment biomarker analysis.
- 6. Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0 or 1 .
- 7. Expected survival time > 3 months. 8. According to the Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), subjects in phase 1a must have at least one evaluable lesion, and subjects in phase 1b must have at least one measurable lesion (a lesion located in areas previously treated with radiotherapy will not be considered a measurable lesion unless there is sufficient evidence to show clear imaging progression of the lesion after radiotherapy; biopsy lesions should be excluded for measurable lesions in subjects in phase 1b).
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- 9. The subject has good organ function as indicated by laboratory results at screening (no cytokine or other corrective medications are allowed within 14 days prior to laboratory tests at screening):Hematology: a) absolute neutrophil count ≥ 1.5 × 10^9/L (1500/mm3); b) platelet count ≥ 100 × 10^9/L (no platelet transfusion within 14 days prior to the investigation); c) hemoglobin ≥ 9.0 g/dL (no red blood cell transfusion within 30 days prior to the investigation); Liver: a) serum total bilirubin ≤ 1.5 × ULN; b) AST and ALT ≤ 3 × ULN (≤ 5 × ULN for subjects with tumor liver metastasis); c) serum albumin ≥ 30 g/L (no albumin transfusion within 21 days prior to investigation); Kidney: blood creatinine ≤ 1.5 × ULN; or creatinine clearance (CrCl) ≥ 50 mL/min (calculated by Cockcroft-Gault formula, see Appendix 4); Coagulation function: international normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (unless the subject is receiving anticoagulant therapy, and the coagulation parameters [PT/INR and APTT] are within the expected range for anticoagulant therapy at screening).
- 10. Women of childbearing potential (WOCBP) must be willing to use 2 adequate methods of contraception or barrier contraception plus hormonal contraception from the time of signing ICF until 6 months after the last dose of study treatment to prevent pregnancy or abstain from heterosexual activity throughout the study; male subjects must agree to take adequate contraceptive measures from the first dose of study treatment until 6 months after the last dose of study treatment .
- 11. Subject are willing and able to complete scheduled visits, treatment plans, laboratory tests, and other study procedures.
Who cannot join
- 1. Subjects who are concurrently participating in another clinical study, unless it is an observational (non-interventional) clinical study or they are in the survival follow-up period of an interventional study.
- 2. Subjects with the following treatments:
- Subjects who have received major surgery within 4 weeks prior to the first dose, excluding minor surgery, such as appendicitis surgery, tissue acquisition for tumor biopsy, etc.;
- Subjects who have received bone marrow (equivalent to pelvic bone marrow area) or extensive radiotherapy within 28 days prior to the first dose; subjects who have received local radiotherapy (e.g., thoracic and rib radiotherapy) within 7 days prior to the first dose of the study drug;
- Subjects who have previously received HPK1 inhibitor treatment. 3. Subjects who have history of active malignancies within the past 2 years, with the exception of tumors in this study and cured local tumors, such as basal cell carcinoma of skin, squamous cell carcinoma of skin, superficial bladder cancer, cervix carcinoma in situ, breast cancer in situ, etc.
- 4. Subjects who have not recovered (i.e., recover to ≤ Grade 1 or baseline) from related AEs (such as alopecia, ≤ Grade 2 sensory neuropathy, or other ≤ Grade 2 AEs that do not pose a safety risk as judged by the investigator) resulting from previous treatments or other anti-tumor therapies.
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- 5. Subjects with unstable brain metastasis: subjects with central nervous system complications requiring emergency neurosurgery (e.g., surgery) (excluding those who have completed surgery for more than 7 days and whose complications have resulted in ≤ Grade 1 side effects); 6. Subjects with epilepsy requiring treatment; subjects with a history of psychotropic drug abuse and unable to abstain or have mental disorders (those who have abstained must meet an observation period without withdrawal reactions for at least 2 weeks).
- 7. Subjects with any of the following cardiovascular diseases/symptoms/signs:
- Mean QTc (corrected QT interval, calculated by Fridericia's formula) at rest: male > 450 ms, female > 470 ms, with the mean QTc of triplicate ECG measurements within ≥ 5 min (at least 1 min interval between two measurements, QT interval measurement should be from the beginning of the QRS complex to the end of the T wave); b) Any important abnormalities with clinically significant in rhythm, conduction, or morphology of the ECG at rest, such as complete left bundle branch block, 2nd and 3rd degree heart block, PR interval > 250 ms, etc.; c) Left ventricular ejection fraction (LVEF) < 50%; 8. Immunodeficiency diseases (HIV) and active hepatitis (hepatitis B virus [HBV], hepatitis C virus [HCV]), excluding carriers with asymptomatic chronic HBV or HCV. Active HBV, HCV, and HIV positive infection is defined as: d) HBsAg is positive and HBV DNA is ≥ 2000 cps/mL (or 500 IU/mL); e) HCV antibody is positive and HCV RNA is higher than the upper limit of normal (ULN) of the study site; f) HIV antibody is positive. 9. Diagnosed interstitial lung disease with or without symptoms, as well as conditions that may cause drug-induced lung toxicity or related pneumonia, or pulmonary symptoms that the investigator considers unsuitable for inclusion or high-risk factors that may lead to interstitial lung disease and are not suitable for inclusion.
- 10. Subjects with other diseases that may affect the efficacy and safety of the study drug, including but not limited to:
- Active infection requiring antibiotic therapy within 14 days prior to the start of study treatment; b) Active autoimmune disease or a history of autoimmune disease, including but not limited to inflammatory bowel disease, autoimmune hepatitis, Guillain-Barré syndrome, demyelinating disease, extensive dermatitis, immune-related interstitial pneumonia, or Grave's disease requiring drug medication; c) History of primary immunodeficiency; d) Active pulmonary tuberculosis; 11. A large amount or symptomatic moderate amount of pleural effusion, pericardial effusion, ascites at screening, and the symptoms are poorly controlled after treatment such as paracentesis and drainage.
- 12. Clinically significant gastrointestinal abnormalities or diseases at screening, resulting in great difficulties in drug intake, transport, or absorption (such as dysphagia, uncontrollable nausea and vomiting), etc.
- 13. History of solid organ transplant. 14. Known or suspected allergy to the study drug or its analogues. 15. Pregnant and lactating women. 16. The investigators consider that the subjects are not suitable to participate in this study (e.g., the treatment is not in the best interest of the subjects, the subjects have poor compliance, etc.).
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
Fudan University Shanghai Cancer Center
Shanghai, 200032
Hongxia Wang, +86-021-34778299, syner2000@163.com
About this study
Official title: A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of HDM2006 Monotherapy in Patients With Advanced Solid Tumors
This is a first-in-human (FIH) study to evaluate the safety and preliminary efficacy of experimental drug HDM2006 in patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- HDM2006
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDM2006Drug
Oral administration within half an hour after a meal, QD
| Study group | Role | What they receive |
|---|---|---|
| HDM2006 | Experimental | In dose escalation phase, participants will be administered escalating doses of HDM2006 at 50 mg QD, ~1000 mg QD, Oral administration within half an hour after a meal. In dose expansion phase, participants will be administered to recommended dose for expansion (RDE) of HDM2006, Oral administration within half an hour after a meal. Receives: Drug: HDM2006 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose limiting toxicity (DLT) events (for dose escalation phase)
DLT will be determined by definition during the DLT observation period.
Measured: up to 21 days following first dose
Incidence and severity of adverse events(for dose escalation phase)
The safety profile of HDM2006 will be assessed by monitoring the adverse events (AE) per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
Measured: Until 30 days after the last dose or initiation of a new antineoplastic therapy, whichever occurs first
Change from baseline in HPK1 expression in tumor tissues (dose expansion)
HPK1 expression levels will be measured using Flow Cytometry. The unit of measure is percentage of positive cells.
Measured: through study completion, an average of 1 year
Changes from baseline in pSLP-76 expression in tumor tissue (dose expansion)
pSLP-76 expression levels will be measured using Flow Cytometry. The unit of measure is percentage of positive cells.
Measured: From baseline through study completion, an average of 1 year
Recommended Phase 2 Dose (RP2D) (for dose expansion phase)
The specific dose level of HDM2006 identified for use in the Phase 2 expansion phase
Measured: through study completion, an average of 1 year
Secondary outcomes (6)
Plasma concentration of HDM2006
Plasma concentration of HDM2006
Measured: up to7 days following last dose
Objective Response Rate (ORR)(for dose escalation phase)
Objective response rate (ORR), which includes best response of complete response (CR) or partial response (PR) as assessed by the investigator.
Measured: through study completion, an average of 1 year
Time to Response (TTR)
TTR is defined as the interval from the start of study therapy to the first documentation of an objective response.
Measured: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Progression free survival (PFS)
PFS is defined as the interval from the start of study therapy to the earlier of the first documentation of disease progression/relapse or death from any cause.
Measured: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Duration of Response (DOR)
DOR is defined as the interval from the first documentation of objective response to the earlier of the first documentation of disease progression/relapse or death from any cause.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to100 months
Overall survival (OS)
OS is defined as the interval from the start of study therapy to death from any cause.
Measured: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start31 Dec 2024
- Primary completionSep 2026 (estimated)
- Study completionMar 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.
- More trials run by Hangzhou Zhongmei Huadong Pharmaceutical 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
- 48 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07377591
- Sponsor's protocol ID
- HDM2006-101
- Other IDs
- CTR20244285
- Status last verified
- Jan 2026
- First submitted
- 11 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of HDM2006 Monotherapy in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07377591
- Acronym / sponsor ID
- HDM2006-101
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Dec 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 30 Jan 2026 (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 first-in-human (FIH) study to evaluate the safety and preliminary efficacy of experimental drug HDM2006 in patients with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HDM2006 | Experimental | Drug: HDM2006In dose escalation phase, participants will be administered escalating doses of HDM2006 at 50 mg QD, ~1000 mg QD, Oral administration within half an hour after a meal. In dose expansion phase, participants will be administered to recommended dose for expansion (RDE) of HDM2006, Oral administration within half an hour after a meal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1. The subjects understand and voluntarily (or legally authorized guardian) sign a written informed consent form (ICF) approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
- 2. Males or females aged ≥ 18 years old. 3. In the dose escalation phase, subjects must have histologically or cytologically confirmed advanced or metastatic solid tumors, who have experienced adequate standard treatment failure, intolerance to standard treatment, or lack of effective standard treatment.
- 4. In the dose expansion phase, subjects must have histologically or cytologically confirmed advanced or metastatic specific types of tumors, who have experienced adequate standard treatment failure, intolerance to standard treatment, or lack of effective standard treatment. These include, but are not limited to, head and neck squamous cell carcinoma, renal cell carcinoma, cervix carcinoma, and other advanced solid tumors, as well as tumor types that showed efficacy signals (CR/PR) in the dose escalation phase.
- 5. In the dose expansion phase, subjects are able to provide fresh or archival (within one year) tumor tissues at the time of screening and are willing to provide tumor tissue biopsy after administration of HDM2006 for baseline and post-treatment biomarker analysis.
- 6. Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0 or 1 .
Key exclusion criteria (13 listed)
- 1. Subjects who are concurrently participating in another clinical study, unless it is an observational (non-interventional) clinical study or they are in the survival follow-up period of an interventional study.
- 4. Subjects who have not recovered (i.e., recover to ≤ Grade 1 or baseline) from related AEs (such as alopecia, ≤ Grade 2 sensory neuropathy, or other ≤ Grade 2 AEs that do not pose a safety risk as judged by the investigator) resulting from previous treatments or other anti-tumor therapies.
- 5. Subjects with unstable brain metastasis: subjects with central nervous system complications requiring emergency neurosurgery (e.g., surgery) (excluding those who have completed surgery for more than 7 days and whose complications have resulted in ≤ Grade 1 side effects); 6. Subjects with epilepsy requiring treatment; subjects with a history of psychotropic drug abuse and unable to abstain or have mental disorders (those who have abstained must meet an observation period without withdrawal reactions for at least 2 weeks).
- 10. Subjects with other diseases that may affect the efficacy and safety of the study drug, including but not limited to:
- 12. Clinically significant gastrointestinal abnormalities or diseases at screening, resulting in great difficulties in drug intake, transport, or absorption (such as dysphagia, uncontrollable nausea and vomiting), 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 |
|---|---|---|
| HDM2006Oral administration within half an hour after a meal, QD | Drug | HDM2006 |
Primary outcome
Incidence of dose limiting toxicity (DLT) events (for dose escalation phase)
Time frame: up to 21 days following first dose
DLT will be determined by definition during the DLT observation period.
Incidence and severity of adverse events(for dose escalation phase)
Time frame: Until 30 days after the last dose or initiation of a new antineoplastic therapy, whichever occurs first
The safety profile of HDM2006 will be assessed by monitoring the adverse events (AE) per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
Change from baseline in HPK1 expression in tumor tissues (dose expansion)
Time frame: through study completion, an average of 1 year
HPK1 expression levels will be measured using Flow Cytometry. The unit of measure is percentage of positive cells.
Changes from baseline in pSLP-76 expression in tumor tissue (dose expansion)
Time frame: From baseline through study completion, an average of 1 year
pSLP-76 expression levels will be measured using Flow Cytometry. The unit of measure is percentage of positive cells.
Recommended Phase 2 Dose (RP2D) (for dose expansion phase)
Time frame: through study completion, an average of 1 year
The specific dose level of HDM2006 identified for use in the Phase 2 expansion phase
6 secondary outcomes
Plasma concentration of HDM2006
Time frame: up to7 days following last dose
Objective Response Rate (ORR)(for dose escalation phase)
Time frame: through study completion, an average of 1 year
Time to Response (TTR)
Time frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Progression free survival (PFS)
Time frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Duration of Response (DOR)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to100 months
Overall survival (OS)
Time frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
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 30 Jan 2026.
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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.
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 HDM2006 in people with Advanced Solid Tumors, run by Hangzhou Zhongmei Huadong Pharmaceutical 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 9 inclusion and 13 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 30 Jan 2026. 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 LingLuo (+86-18500798288, cxyluoling@eastchinapharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose limiting toxicity (DLT) events (for dose escalation phase) (time frame: up to 21 days following first dose). The study lists 5 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 30 Jan 2026.