Advanced Solid TumorsPhase 1NCT07100249
A Study of HDM2012 in Patients With Advanced Solid Tumor
A Phase 1 study testing HDM2012 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 HDM2012 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?
- HDM2012
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteChina
- Study dates
- 6 Aug 2025to Jun 2028
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The participants understand and voluntarily (or their legally authorized guardian) sign a written informed consent form (ICF) approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
- Males or females aged ≥18 years and less than or equal to 75 years.
- For escalation cohorts in the dose escalation phase: subjects must have histologically or cytologically confirmed advanced or metastatic malignant solid tumors, who have been previously treated and failed after adequate standard therapy, and have no standard treatment options available that have the potential to confer clinical benefit, including but not limited to gastric cancer (including esophagogastric junction adenocarcinoma), colorectal cancer, pancreatic cancer, etc.
- For backfill cohorts in the dose escalation phase and the dose expansion phase: subjects must have histologically or cytologically confirmed advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma) or colorectal cancer.
- Tumor tissue samples must be sent to the central laboratory for immunohistochemical testing.
- ECOG performance status of 0 - 1.
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- Expected survival time >3 months.
- Per RECIST v1.1 criteria: Ia phase subjects in dose escalation cohort must have at least one evaluable lesion; Ia phase subjects in backfill cohort and Ib phase subjects must have at least one measurable lesion (tumor lesions in previously irradiated areas are not considered measurable unless clear radiographic progression post-radiation is documented; measurable lesions in Ib phase should exclude biopsy sites).
- Adequate organ function demonstrated by screening laboratory tests (no growth factors or corrective treatments allowed within 14 days prior to screening tests).
- Willingness of women of reproductive potential to observe conventional and highly effective birth control methods with failure rates of <1% for the duration of treatment and for 7 months following the last dose of study treatment; Willingness of men of reproductive potential to observe conventional and highly effective birth control methods with failure rates of <1% for the duration of treatment and for 4 months following the last dose of study treatment; this must include barrier methods such as condom or diaphragm with spermicidal gel. Women of reproductive potential have a negative serum pregnancy test within 7 days before study enrollment; For male participants with a nonpregnant female partner of child-bearing potential and a woman of child-bearing potential, one of the following highly effective birth control methods with a failure rate of less than 1% per year when used consistently and correctly are recommended .
- Willing and able to complete scheduled visits, treatment plans, laboratory tests, and other study procedures.
Who cannot join
- Prior treatment with antibody-drug conjugates (ADCs) containing topoisomerase I inhibitors.
- Subjects who have received the following treatments:
- Major surgery within 4 weeks prior to first dose, except minor procedures such as appendectomy, tumor biopsy, etc.;
- Radiation therapy to bone marrow (equivalent to pelvic marrow area) or extensive radiation within 4 weeks prior to first dose; local radiotherapy (e.g., thoracic vertebrae and rib radiation) within 2 weeks prior to first dose;
- Continuous systemic corticosteroid administration (>10 mg/day prednisone equivalent) within 2 weeks prior to first dose; low-dose corticosteroids (≤10 mg/day prednisone equivalent) are permitted if dose has been stable for 4 weeks;
- Subjects who have received other systemic anti-tumor therapies within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose, unless a scientifically justified washout period is provided, such as relevant PK/PD of the prior therapy and relevant clinical and laboratory parameters, based on the characteristics of preceding therapy.
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- Active malignancies within past 2 years, except studied cancer and cured localized tumors (e.g., basal cell carcinoma, squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, breast carcinoma in situ).
- Subjects have not recovered from prior treatment-related or other anti-cancer therapy-related AEs (alopecia, ≤Grade 2 sensory neuropathy, or other ≤Grade 2 AEs deemed non-safety risks by investigator are acceptable) to ≤Grade 1 or baseline.
- Known active central nervous system metastases. Untreated asymptomatic or treated brain metastasis subjects with radiologically confirmed stable status for ≥4 weeks and no need for steroids/antiepileptics ≥2 weeks may be enrolled. Leptomeningeal metastases (symptomatic or asymptomatic) must be excluded.
- Subjects with any cardiovascular/cerebrovascular diseases/conditions/indications.
- At screening, participants with active syphilis, immunodeficiency disease (HIV), active hepatitis (HBV, HCV), except for asymptomatic chronic hepatitis B or C carriers.
- History of interstitial pneumonia, idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonia, idiopathic pneumonia, or evidence of active pneumonia found on chest computed tomography (CT) during screening; previous use of hormone shock therapy for pneumonia.
- Complete or incomplete intestinal obstruction or imaging findings indicating risk of intestinal obstruction.
- Presence of other diseases that may affect the efficacy and safety of the IMP.
- Presence of large or symptomatic moderate pleural effusion, pericardial effusion, or ascites during screening that remains poorly controlled despite treatments like drainage.
- Unstable thrombotic events requiring therapeutic intervention within 6 months prior to screening, including deep vein thrombosis, arterial thrombosis, and pulmonary embolism; excluding catheter-related thrombosis.
- Previous solid organ transplantation.
- Known or suspected allergy to IMP components or their analogs.
- Pregnant or breastfeeding women.
- Investigator's judgment that the subject is unsuitable for participation (e.g., non-optimal treatment benefit, poor compliance, etc.).
- Received strong or moderate CYP3A4 inhibitors or inducers within 1 week prior to dosing or 5 half-lives (whichever is longer), or anticipated need for long-term use of strong or moderate CYP3A4 inhibitors or inducers during study intervention and within 30 days after last dose.
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
Zhongshan Hospital, Fudan University
Shanghai
Tianshu Liu, 86-02164041990, liu.tianshu@zs-hospital.sh.cn
About this study
Official title: A Phase Ia/Ib Clinical Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of HDM2012 in Subjects With Advanced Solid Tumors
This is a first-in-human (FIH) study to evaluate the safety and preliminary efficacy of experimental drug HDM2012 in patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- HDM2012
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDM2012Drug
HDM2012 will be administered via IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| HDM2012 | Experimental | In dose escalation phase, participants will be administered escalating doses of HDM2012 at 1.0~5.2mg/kg IV on Day 1 of repeated 21-day cycles. In dose expansion phase, participants will be administered to recommended dose for expansion (RDE) of HDM2012 on Day 1 of repeated 21-day cycles . Receives: Drug: HDM2012 |
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 HDM2012 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
Objective Response Rate (ORR) (for dose expansion 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
Recommended Phase 2 Dose (RP2D) (for dose expansion phase)
The selection of RP2D will be based on consideration of overall safety information together with available pharmacokinetic, E-R relationships, and efficacy data.
Measured: through study completion, an average of 1 year
Secondary outcomes (8)
Plasma concentration of HDM2012
Plasma concentration of HDM2012
Measured: up to7 days following last dose
Immunogenicity
Number and percentage of anti-drug antibody (ADA)-positive patients will be assessed.
Measured: up to 7 days following last dose
Incidence and severity of adverse events(for dose expansion phase)
The safety profile of HDM2012 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
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 posted3 Aug 2025
- Study start6 Aug 2025
- Primary completionOct 2027 (estimated)
- Study completionJun 2028 (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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 129 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07100249
- Sponsor's protocol ID
- HDM2012-101
- Status last verified
- Aug 2025
- First submitted
- 16 Jul 2025
- Last updated
- 8 Aug 2025
- 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 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia/Ib Clinical Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of HDM2012 in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07100249
- Acronym / sponsor ID
- HDM2012-101
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 129 participants (estimated)
- Lead sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Aug 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 3 Aug 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 first-in-human (FIH) study to evaluate the safety and preliminary efficacy of experimental drug HDM2012 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 |
|---|---|---|
| HDM2012 | Experimental | Drug: HDM2012In dose escalation phase, participants will be administered escalating doses of HDM2012 at 1.0~5.2mg/kg IV on Day 1 of repeated 21-day cycles. In dose expansion phase, participants will be administered to recommended dose for expansion (RDE) of HDM2012 on Day 1 of repeated 21-day cycles . |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- The participants understand and voluntarily (or their legally authorized guardian) sign a written informed consent form (ICF) approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
- Males or females aged ≥18 years and less than or equal to 75 years.
- For escalation cohorts in the dose escalation phase: subjects must have histologically or cytologically confirmed advanced or metastatic malignant solid tumors, who have been previously treated and failed after adequate standard therapy, and have no standard treatment options available that have the potential to confer clinical benefit, including but not limited to gastric cancer (including esophagogastric junction adenocarcinoma), colorectal cancer, pancreatic cancer, etc.
- For backfill cohorts in the dose escalation phase and the dose expansion phase: subjects must have histologically or cytologically confirmed advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma) or colorectal cancer.
- Tumor tissue samples must be sent to the central laboratory for immunohistochemical testing.
Key exclusion criteria (21 listed)
- Prior treatment with antibody-drug conjugates (ADCs) containing topoisomerase I inhibitors.
- Subjects who have received the following treatments:
- Active malignancies within past 2 years, except studied cancer and cured localized tumors (e.g., basal cell carcinoma, squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, breast carcinoma in situ).
- Subjects have not recovered from prior treatment-related or other anti-cancer therapy-related AEs (alopecia, ≤Grade 2 sensory neuropathy, or other ≤Grade 2 AEs deemed non-safety risks by investigator are acceptable) to ≤Grade 1 or baseline.
- Known active central nervous system metastases. Untreated asymptomatic or treated brain metastasis subjects with radiologically confirmed stable status for ≥4 weeks and no need for steroids/antiepileptics ≥2 weeks may be enrolled. Leptomeningeal metastases (symptomatic or asymptomatic) must be excluded.
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 |
|---|---|---|
| HDM2012HDM2012 will be administered via IV infusion. | Drug | HDM2012 |
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 HDM2012 will be assessed by monitoring the adverse events (AE) per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
Objective Response Rate (ORR) (for dose expansion phase)
Time frame: through study completion, an average of 1 year
Objective response rate (ORR), which includes best response of complete response (CR) or partial response (PR) as assessed by the investigator.
Recommended Phase 2 Dose (RP2D) (for dose expansion phase)
Time frame: through study completion, an average of 1 year
The selection of RP2D will be based on consideration of overall safety information together with available pharmacokinetic, E-R relationships, and efficacy data.
8 secondary outcomes
Plasma concentration of HDM2012
Time frame: up to7 days following last dose
Immunogenicity
Time frame: up to 7 days following last dose
Incidence and severity of adverse events(for dose expansion phase)
Time frame: Until 30 days after the last dose or initiation of a new antineoplastic therapy, whichever occurs first
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 8 Aug 2025.
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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 HDM2012 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 11 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: looking for participants now, as of the sponsor's last update on 8 Aug 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 Hua Liu (+8615821804591, cxyliuhua@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 4 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 8 Aug 2025.