Advanced Malignant Solid TumorsPhase 1NCT07824934
HEC-921 Injection as Monotherapy and in Combination With Antineoplastic Therapies in Patients With Advanced Malignant Solid Tumors
A Phase 1 study testing HEC-921, Oxaliplatin and Capecitabine in people with Advanced Malignant Solid Tumors, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
Trial summary
A Phase I Study of HEC-921 Injection as Monotherapy and in Combination with Other AntineoplasticTherapy in Patients with Advanced Malignant Solid Tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Solid Tumors
- What is being tested?
- HEC-921, Oxaliplatin and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 18 Sep 2026to Jan 2029
- Phase
- Phase 1
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
- Trial participants aged ≥18 years at the time of signing the informed consent form, either male or female;
- Patients with advanced malignant solid tumors confirmed by histology or cytology, who can provide archived or recently collected tumor tissue sections (recently collected samples are preferred), and meet the following requirements:
- Monotherapy dose escalation and dose expansion phases: Patients with advanced malignant solid tumors who have failed or are intolerant to standard therapy, or for whom no standard therapy exists, and whose tumor tissue is LY6G6D+. During the monotherapy dose escalation phase in the low-dose cohorts , there is no restriction on LY6G6D expression in participants' tumor tissue.
- Combination Therapy Phase: Histologically confirmed unresectable advanced colon adenocarcinoma or rectal adenocarcinoma, with no prior systemic therapy, deemed by the investigator suitable for receiving CAPOX combined with bevacizumab as first-line treatment for advanced disease; tumor tissue LY6G6D+ .
- Eastern Cooperative Oncology Group (ECOG) performance status: 0-1;
- Expected survival time ≥12 weeks;
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- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1);
- Adequate organ function:
- Female or male trial participants of childbearing potential must agree to have no plans for reproduction and to voluntarily use highly effective contraceptive measures with their partner during the study and for 6 months after the last dose; female trial participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose and must not be breastfeeding;
- The patient voluntarily participates, provides fully informed consent, signs the written informed consent form, and demonstrates good compliance.
Who cannot join
- Receipt of the following medications or treatments prior to the first dose:
- Received anti-tumor therapies such as chemotherapy or immunotherapy, or other investigational drugs within 3 weeks prior to the first dose; or received oral fluoropyrimidines, small-molecule targeted drugs, or traditional Chinese medicine with anti-tumor indications within 2 weeks prior to the first dose;
- Received radiotherapy (palliative radiotherapy for local bone/brain lesions is permitted if completed within 2 weeks prior to the first dose), major surgical procedures (not fully recovered from surgery or injury), or any live or attenuated live vaccines within 4 weeks prior to the first dose; or planned to receive live vaccines after enrollment;
- Patients who received systemic treatment with corticosteroids (prednisone >10 mg/day or equivalent) for more than 1 week or other immunosuppressants within 2 weeks prior to the first dose. Inhaled or topical corticosteroids, or systemic prednisone ≤10 mg/day or equivalent doses of similar drugs, are permitted;
- Presence of active central nervous system metastases. Screening is permitted if the patient previously received radiotherapy or surgery, imaging within 4 weeks prior to the first dose indicates stable brain metastases without progression or new neurological symptoms, and corticosteroid therapy was discontinued at least 2 weeks prior to the first dose. Patients with leptomeningeal metastases or brainstem metastases are excluded regardless of treatment status;
- Occurrence of immune-related adverse events leading to permanent discontinuation during prior treatment with immune checkpoint inhibitors (e.g., anti-PD-(L)1, CTLA-4, LAG-3 inhibitors, etc.);
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- Prior receipt of LY6G6D-targeted therapy or 4-1BB (CD137)-related therapy (including CAR-T, monoclonal antibodies, bispecific antibodies, etc.);
- Presence of symptomatic pleural effusion, ascites, or pericardial effusion requiring repeated interventions (e.g., puncture or drainage);
- History of interstitial lung disease or prior non-infectious pneumonia treated with corticosteroids, or evidence of active pneumonia on imaging during the screening period;
- Toxicity from prior anti-tumor therapy has not recovered to ≤ Grade 1 as defined by the Common Terminology Criteria for Adverse Events (CTCAE v6.0) or to the level specified in the inclusion/exclusion criteria, except for the following: relevant toxicities deemed well-controlled by the investigator and not affecting the safety and compliance of the trial participant's use of the investigational; product may be enrolled upon confirmation with the Sponsor;
- Occurrence of a serious infection (CTCAE v6.0 > Grade 2) within 4 weeks prior to the first administration of the investigational product, such as severe pneumonia requiring hospitalization, bacteremia, or infectious complications; or occurrence of an active infection requiring intravenous anti-infective treatment or unexplained fever > 38.5°C within 2 weeks prior to the first administration of the investigational product (trial participants with fever caused by the tumor may be enrolled upon judgment by the investigator);
- Occurrence of gastrointestinal perforation, fistula, intra-abdominal abscess, bleeding, or a clear tendency to bleed (including but not limited to: severe esophageal-gastric varices with a risk of bleeding, local active gastrointestinal ulcer lesions [stable ulcer condition assessed by the investigator may be considered for inclusion], persistent positive fecal occult blood, etc.) within 6 months prior to randomization; for patients with persistent positive fecal occult blood, if they are patients with CRC or gastric cancer, and after detailed assessment it is deemed that the positive occult blood test is related to the tumor (e.g., local bleeding or ulcers caused by the tumor), and under tumor treatment or disease control, the gastrointestinal bleeding is stable and has not caused clinical symptoms (e.g., anemia, hypotension, etc.), they may be considered for inclusion;
- Severe cardiovascular or cerebrovascular disease, including but not limited to: myocardial infarction, severe/unstable angina, congestive heart failure (New York Heart Association [NYHA] functional class ≥2), clinically significant supraventricular or ventricular arrhythmias requiring pharmacological intervention, aortic aneurysm requiring surgical repair, any arterial thrombotic/embolic event, Grade 3 or higher (CTCAE v6.0) venous thrombotic/embolic event, transient ischemic attack, or cerebrovascular accident occurring within 6 months prior to the first study dose; left ventricular ejection fraction (LVEF) <50% by echocardiography; corrected QT interval (QTc) >480 ms (calculated using the Fridericia method; if QTc is abnormal, three consecutive measurements may be taken at 2-minute intervals and averaged);
- Active autoimmune disease requiring systemic treatment (e.g., corticosteroids or immunosuppressive drugs) within 2 years prior to the first dose, including but not limited to: systemic lupus erythematosus, multiple sclerosis, rheumatoid arthritis, inflammatory bowel disease, vasculitis, etc. However, screening is permitted for hypothyroidism, adrenal insufficiency, or hypopituitarism controlled solely by hormone replacement therapy; type 1 diabetes mellitus; psoriasis or vitiligo not requiring systemic treatment; and childhood asthma/allergies that have resolved;
- History of another malignant tumor within 5 years prior to the first dose; except for cured localized tumors, including carcinoma in situ of the cervix, basal cell carcinoma of the skin, and carcinoma in situ of the prostate;
- Active tuberculosis; hepatitis B (hepatitis B surface antigen [HBsAg] positive and HBV DNA >1000 copies/mL or 200 IU/mL); or hepatitis C (hepatitis C antibody [HCVAb] positive and HCV RNA above the lower limit of detection at the study center);
- History of immunodeficiency, including positive test for human immunodeficiency virus (HIV), or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; Other severe physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the study, affect treatment compliance, or interfere with study results, as determined by the investigator to render the participant unsuitable for this study.
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, 200032
Liu Tianshu, MD, 86+13681973996, liu.tianshu@zs-hospital.sh.cn
About this study
Official title: A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HEC-921 Injection as Monotherapy and in Combination With Other Antineoplastic Therapies in Patients With Advanced Malignant Solid Tumors
A Phase I Study of HEC-921 Injection as Monotherapy and in Combination with Other AntineoplasticTherapy in Patients with Advanced Malignant Solid Tumors
Read the detailed description
This is a Phase I open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamic (PD) characteristics, immunogenicity and antitumor activity of HEC-921 injection as monotherapy and in combination with other antineoplastic therapies in patients with advanced malignant tumors. The recommended Phase II dose (RP2D) will be determined based on safety, tolerability, and pharmacokinetics.
- Conditions
- Advanced Malignant Solid Tumors
- Being tested
- HEC-921, Oxaliplatin, Capecitabine, Bevacizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEC-921Drug
Patients will receive specific dose of HEC-921 via intravenous infusion.
HEC-921Drug
Administered via intravenous infusion on Day 1 at the corresponding dose
OxaliplatinDrug
130 mg/m², administered via intravenous infusion on Day 1
CapecitabineDrug
1000 mg/m² per dose, orally twice daily on Days 1-14
BevacizumabDrug
7.5 mg/kg, administered via intravenous infusion on Day 1
| Study group | Role | What they receive |
|---|---|---|
| HEC-921 Monotherapy Study | Experimental | Not described Receives: Drug: HEC-921 |
| Combination Therapy Study | Experimental | HEC-921 in combination with capecitabine plus oxaliplatin (CAPOX) and bevacizumab Receives: Drug: HEC-921; Drug: Oxaliplatin; Drug: Capecitabine; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicity (DLT)
Proportion of participants with dose limiting toxicities during DLT observation window, to identify monotherapy and combination derive maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D).
Measured: The DLT observation period is 21 days after the first administration of HEC-921
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
The severity of adverse events (AEs) will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 6.0.
Measured: From first dose of study drug up to 1-year follow-up
Secondary outcomes (24)
Objective Response Rate (ORR)
The proportion of trial participants achieving complete response (CR) and partial response (PR) by the investigator based on RECIST 1.1 criteria.
Measured: From first dose of study drug up to 1-year follow-up
Disease Control Rate (DCR)
The proportion of trial participants achieving CR, PR, or stable disease (SD) (≥6 weeks) by the investigator based on RECIST 1.1 criteria.
Measured: From first dose of study drug up to 1-year follow-up
Duration of Response
Time from the first occurrence of CR or PR to the first occurrence of progressive disease (PD) or death (whichever occurs first). DoR applies only to trial participants achieving CR or PR by the investigator based on RECIST 1.1 criteria.
Measured: From first dose of study drug up to 1-year follow-up
Progression-Free Survival ( PFS)
The time from the first dose administration to the first documented PD according to RECIST v1.1 criteria or death from any cause (whichever occurs first) by the investigator based on RECIST 1.1 criteria.
Measured: from the first dose administration to the first documented PD or death from any cause (whichever occurs first) , up to 1-year follow-up
Overall Survival ( OS)
Time from the first dose administration to death from any cause by the investigator based on RECIST 1.1 criteria.
Measured: Time from the first dose administration to death from any cause,up to 1-year follow-up
Maximum observed plasma concentration (Cmax)
to assess the pharmacokinetic profile
Measured: From the first dose of the study drug to week 18
Area under the plasma concentration-time curve from time zero to last quantifiable concentration (AUClast)
to assess the pharmacokinetic profile
Measured: From the first dose of the study drug to week 18
Positive rate of anti-drug antibodies (ADA)
The positive rate of anti-drug antibodies (ADA) against HEC-921 injection will be assessed in evaluable participants
Measured: From the first dose of the study drug to week 18
Area under the plasma concentration-time curve extrapolated to infinity (AUCinf)
to assess the pharmacokinetic profile
Measured: From the first dose of the study drug to week 18
Time to maximum observed plasma concentration (Tmax)
to assess the pharmacokinetic profile
Measured: From the first dose of the study drug to week 18
Terminal elimination half-life (t1/2)
to assess the pharmacokinetic profile
Measured: From the first dose of the study drug to week 18
Mean residence time (MRT)
to assess the pharmacokinetic profile
Measured: From the first dose of the study drug to week 18
Clearance (CL)
to assess the pharmacokinetic profile
Measured: From the first dose of the study drug to week 18
Apparent volume of distribution at steady state (Vss)
to assess the pharmacokinetic profile
Measured: From the first dose of the study drug to week 18
AUC extrapolation ratio (AUC%Extrap)
to assess the pharmacokinetic profile
Measured: From the first dose of the study drug to week 18
Maximum steady-state plasma concentration (Cmax,ss)
to assess the pharmacokinetic profile
Measured: From the first dose of the study drug to week 18
Minimum steady-state plasma concentration (Cmin,ss)
to assess the pharmacokinetic profile
Measured: From the first dose of the study drug to week 18
Average steady-state plasma concentration (Cav,ss)
to assess the pharmacokinetic profile
Measured: From the first dose of the study drug to week 18
Area under the plasma concentration-time curve over one dosing interval at steady state (AUCtau)
to assess the pharmacokinetic profile
Measured: From the first dose of the study drug to week 18
Steady-state clearance (CLss)
to assess the pharmacokinetic profile
Measured: From the first dose of the study drug to week 18
Accumulation index (R)
to assess the pharmacokinetic profile
Measured: From the first dose of the study drug to week 18
Degree of fluctuation (DF)
to assess the pharmacokinetic profile
Measured: From the first dose of the study drug to week 18
Titer of anti-drug antibodies (ADA)
Titer of anti-drug antibodies (ADA) against HEC-921 injection will be assessed in evaluable participants.
Measured: From the first dose of the study drug to week 18
Detection rate of neutralizing antibodies (NAb) in ADA-positive samples
Neutralizing antibodies (NAb) will be tested in ADA-positive samples collected, if needed.
Measured: From the first dose of the study drug to week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start18 Sep 2026
- Primary completionMay 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant 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
- Model description
- This study adopts a sequential group design. The monotherapy dose escalation and expansion cohorts will be conducted first, followed by the combination therapy dose escalation and expansion cohorts.
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Liu Tianshu, MD, Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824934
- Sponsor's protocol ID
- HEC-921-ST-101
- Status last verified
- Sep 2026
- First submitted
- 5 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No