Advanced Solid TumorsPhase 1NCT06238401
An Open-label, Multi-center, Dose-escalation and Cohort Expansion Phase I/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile and Efficacy of ACR246 in Patients With Advanced Solid Tumors
A Phase 1 study testing ACR246 for injection in people with Advanced Solid Tumors, run by Hangzhou Adcoris Biopharmacy Co., Ltd at 6 sites in China.
Trial summary
The goal of the study is to evaluate the safety and tolerability of ACR246 in patients with advanced solid tumors, to determine the maximum tolerated dose (MTD) and Phase II recommended dose (RP2D) of ACR246. 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?
- ACR246 for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 6 sitesChina
- Study dates
- 29 Oct 2024to 30 Nov 2026
- 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
- Patients must meet all of the following inclusion criteria to be enrolled in this study:
- Be willing to sign the ICF, be able to understand the study, and be willing to follow and be able to complete all the study procedures;
- Male and female, aged 18 to 75 years (inclusive);
- For phase I dose escalation study: Patients with histologically or cytologically confirmed recurrent or metastatic unresectable advanced solid tumors who experience disease progression after receiving systemic standard therapy, or have no standard therapy;
- For phase IIa cohort escalation study: Patients with histologically or cytologically confirmed recurrent or metastatic unresectable advanced solid tumors who experience disease progression after receiving systemic standard therapy, or have no standard therapy, including the following malignant tumors:
- Esophageal cancer: Patients who experience disease progression after receiving prior ≥2 lines of chemotherapy;
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- Colorectal cancer: Patients who experience disease progression after receiving prior ≥2 lines of chemotherapy;
- NSCLC: Patients with NSCLC meet the following conditions, and are unable to continue subsequent standard of care or have no standard of care available as judged by the investigator:
- Positive for driver genes (such as EGFR, ALK, ROS1, MET); disease progression after current standard targeted therapy; ii. Negative for driver genes (such as EGFR, ALK, ROS1, MET); disease progression after prior ≥1 line(s) of therapy, and use of platinum-based drugs in at least one regimen; d) Ovarian cancer: Patients who experience disease progression after receiving at least one prior line of chemotherapy; the patient must receive prior treatment with PARP inhibitors if harboring BRCA 1/2 mutations; e) Prostate cancer: Patients with metastatic castration-resistant prostate cancer who receive at least one prior systemic therapy; f) Other solid tumors: Patients who experience disease progression after receiving prior standard of care, have no standard of care available, or are currently unsuitable to receive standard of care.
- Positive for 5T4 expression as detected by the central laboratory (phase IIa only);
- Phase I: Presence of at least one evaluable lesion by imaging as per RECIST v1.1; phase IIa: Presence of at least one measurable lesion by imaging as per RECIST v1.1. Lesions that are previously treated with radiotherapy cannot be considered target lesions unless the lesions have unequivocal progression;
- Toxicity from prior antitumor therapies returned to Grade ≤1 as defined by NCI-CTCAE v5.0, but with the exception for alopecia- or antitumor therapy-associated events that can be tolerated by patients as judged by the investigator;
- Eastern Cooperative Oncology Group (ECOG) performance status score of ≤1;
- Adequate bone marrow, liver, kidney, and coagulation functions (refer to the upper limit of normal [ULN] of each clinical study site):
- Bone marrow (did not receive blood transfusion or use drugs that increase white blood cells and platelets, e.g., cytokines or erythropoietin, within 2 weeks prior to laboratory tests):
- Absolute neutrophil count (ANC) count ≥1.5×109/L; Platelet (PLT) ≥100×109/L; Haemoglobin (Hb) ≥90 g/L;
- Liver function:
- Total bilirubin (TBiL) ≤1.5 × ULN; ALT, AST ≤2.5 × ULN in patients without metastases to liver; ALT, AST ≤5 × ULN in patients with metastases to liver;
- Kidney function:
- Creatinine ≤1.5 × ULN or creatinine clearance (Ccr) ≥60 mL/min (according to the Cockcroft-Gault formula);
- Coagulation function:
- International normalized ratio (INR) ≤1.5 × ULN; Activated partial thromboplastin time (APTT) ≤1.5 × ULN;
- Expected survival ≥3 months;
- At rest, left ventricular ejection fraction (LVEF) ≥50%;
- Eligible male patients of reproductive potential and female patients of childbearing potential, along with his/her partner, must agree to use medically acceptable contraceptive measures (e.g., hormonal contraception, barrier method, or abstinence, etc.) during the study and for at least 6 months after the last dose.
Who cannot join
- Patients meeting any of the following criteria should be excluded from the study:
- Comorbid with other primary malignant tumors, except for:
- Resolved non-invasive basal cell carcinoma or squamous cell carcinoma, and cervical carcinoma in situ;
- Or other malignant tumors with a more than 5-year disease free survival;
- Malignant tumors other than those with a more than 5-year disease free survival, but the patient may obtain benefits after enrollment as he/she has a stable condition assessed by the investigator (for phase I dose escalation study only);
- Received any systemic antitumor therapies (including chemotherapy, radiotherapy, biological therapy, immunotherapy, etc.) within 4 weeks prior to the first dose of the investigational drug; Received small molecule targeted drugs, Chinese herbal medicines or Chinese patent medicines with antitumor indications or systemic immunomodulators (including but not limited to interferon, interleukin-2, and tumor necrosis factor) within 2 weeks prior to the first dose of the investigational drug;
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- Prior treatment with any 5T4-targeted drug therapy;
- Presence of active brain metastases or spinal cord metastases, being ineligible for inclusion in the study as assessed by the investigator; however, patients who require no radiotherapy, surgery or treatment with corticosteroids to control the symptoms of metastases within 1 month prior to screening may be included in the study; patients with metastases to meninges will be excluded;
- Known hypersensitivity to any of the active ingredients or excipients of ACR246, or documented history of allergy to protein drugs, experienced other serious allergic reactions, for which, the patient is not suitable to receive ACR246 as assessed by the investigator;
- History of severe heart disease as assessed by the investigator, e.g., symptomatic cardiac failure congestive (CHF) [Class ≥2 as per New York Heart Association (NYHA) functional classification], and history of myocardial infarction or unstable angina pectoris within 6 months prior to screening;
- Serious arrhythmia requiring medication, e.g., corrected QT interval (Frederica formula) >450 msec for male or >470 msec for female, complete left bundle branch block, third-degree atrioventricular block;
- Uncontrolled hypertension after medication treatment (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg);
- Dyspnoea at rest, severe primary pulmonary disorder currently requiring continuous oxygen therapy, history of interstitial lung disease and radiation pneumonitis, uncontrolled or potential risk of pulmonary fibrosis, or clinically active lung diseases as indicated by any proof;
- Serious or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, heart, liver or kidney diseases), as assessed by the investigator;
- Positive antibody tests for active hepatitis B (hepatitis B surface antigen positive and HBV DNA≥1×103 IU/mL), active hepatitis C (hepatitis C antibody positive and HCV RNA > lower limit of detection), active syphilis (treponema pallidum antibody positive and Rapid Plasma Reagin (RPR) titer positive), and human immunodeficiency virus (HIV) antibody positive, or any uncontrolled infections;
- Had a major surgery or serious traumatic injuries (without complete recovery as assessed by the investigator) within 4 weeks prior to the first dose of the investigational drug, or plans to undergo a major surgery during the study;
- Pregnant or lactating women;
- Serious arterial/venous thrombosis (e.g., cerebrovascular accident [including transient ischaemic attack]), deep venous thrombosis, pulmonary embolism within 1 year prior to treatment with the investigational drug, or haemorrhagic diathesis within 30 days prior to enrollment, or existence of risks of massive gastrointestinal hemorrhage, as assessed by the investigator;
- Use of strong cytochrome P450 3A enzymes (CYP450 3A) inhibitors or inducers could not be stopped during treatment with the investigational drug;
- Active eye disorders, such as keratitis, corneal disorder or eye infection, requiring intervention (including surgery or drug therapy, etc.);
- Other condition that in the opinion of the investigator is not suitable for the study, e.g., poor compliance.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Yu Tang, 010-87788713, cancergcp@163.com
Ning Li, professor
- Recruiting
Beijing Tumor Hospital
Beijing, Beijing Municipality, 100142
Jun Huang, 010-88196023, gcpxy01@bjcancer.org
Lin Shen, professor
- Recruiting
Shandong First Medical University affiliated Cancer Hospital of Shandong
Shandong, Jinan, 250117
Huijuan Li, 0531-67626073, ywb234@126.com
Yuping Sun, professor
- Recruiting
ShangHai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Yu Feng, 021-22200000-7085, xkyyGCP2021@163.com
Baohui Han, professor
- Recruiting
ShangHai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233
Xiao Cheng, 021-24056429, liuyuangcp@163.com
Haiyan Hu, professor
- Recruiting
Zhejiang Cancer Hospital
Zhejiang, Hangzhou, 310022
Weizhen Xu, 0571-88128276, zjchgcp@163.com
Zhengbo Song, professor
About this study
The goal of the study is to evaluate the safety and tolerability of ACR246 in patients with advanced solid tumors, to determine the maximum tolerated dose (MTD) and Phase II recommended dose (RP2D) of ACR246.
- Conditions
- Advanced Solid Tumors
- Being tested
- ACR246 for injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACR246 for injectionDrug
80 mg/vial
| Study group | Role | What they receive |
|---|---|---|
| ACR246 for injection | Experimental | Administered by intravenous infusion on Day 1 every 3 weeks (Q3W). Receives: Drug: ACR246 for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability:
Incidence and characteristics of adverse events (AEs), serious adverse events (SAEs) and dose-limiting toxicities (DLTs).
Measured: 21days
Secondary outcomes (8)
PK parameters of ACR246（Cmax）
To assess the pharmacokinetic profile in patients with advanced solid tumors
Measured: 21days
PK parameters of ACR246（Tmax）
To assess the pharmacokinetic profile in patients with advanced solid tumors
Measured: 21days
PK parameters of ACR246（t1/2）
To assess the pharmacokinetic profile in patients with advanced solid tumors
Measured: 21days
PK parameters of ACR246（AUC0-t）
To assess the pharmacokinetic profile in patients with advanced solid tumors
Measured: 21days
PK parameters of ACR246（AUC0-∞）
To assess the pharmacokinetic profile in patients with advanced solid tumors
Measured: 21days
PK parameters of ACR246（CL）
To assess the pharmacokinetic profile in patients with advanced solid tumors
Measured: 21days
PK parameters of ACR246（Vd）
To assess the pharmacokinetic profile in patients with advanced solid tumors
Measured: 21days
PK parameters of ACR246（mean residence time (MRT)）
To assess the pharmacokinetic profile in patients with advanced solid tumors
Measured: 21days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start29 Oct 2024
- Primary completion30 May 2026 (estimated)
- Study completion30 Nov 2026 (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
- Single group
- Masking
- None (open label)
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Adcoris Biopharmacy Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06238401
- Sponsor's protocol ID
- ACR246-101
- Status last verified
- Mar 2025
- First submitted
- 17 Jan 2024
- Last updated
- 24 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center, Dose-escalation and Cohort Expansion Phase I/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile and Efficacy of ACR246 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06238401
- Acronym / sponsor ID
- ACR246-101
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- Hangzhou Adcoris Biopharmacy Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 29 Oct 2024 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 2 Feb 2024 (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.
The goal of the study is to evaluate the safety and tolerability of ACR246 in patients with advanced solid tumors, to determine the maximum tolerated dose (MTD) and Phase II recommended dose (RP2D) of ACR246.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACR246 for injection | Experimental | Drug: ACR246 for injectionAdministered by intravenous infusion on Day 1 every 3 weeks (Q3W). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Be willing to sign the ICF, be able to understand the study, and be willing to follow and be able to complete all the study procedures;
- Male and female, aged 18 to 75 years (inclusive);
- For phase I dose escalation study: Patients with histologically or cytologically confirmed recurrent or metastatic unresectable advanced solid tumors who experience disease progression after receiving systemic standard therapy, or have no standard therapy;
- For phase IIa cohort escalation study: Patients with histologically or cytologically confirmed recurrent or metastatic unresectable advanced solid tumors who experience disease progression after receiving systemic standard therapy, or have no standard therapy, including the following malignant tumors:
- Positive for 5T4 expression as detected by the central laboratory (phase IIa only);
Key exclusion criteria (21 listed)
- Comorbid with other primary malignant tumors, except for:
- Received any systemic antitumor therapies (including chemotherapy, radiotherapy, biological therapy, immunotherapy, etc.) within 4 weeks prior to the first dose of the investigational drug; Received small molecule targeted drugs, Chinese herbal medicines or Chinese patent medicines with antitumor indications or systemic immunomodulators (including but not limited to interferon, interleukin-2, and tumor necrosis factor) within 2 weeks prior to the first dose of the investigational drug;
- Prior treatment with any 5T4-targeted drug therapy;
- Presence of active brain metastases or spinal cord metastases, being ineligible for inclusion in the study as assessed by the investigator; however, patients who require no radiotherapy, surgery or treatment with corticosteroids to control the symptoms of metastases within 1 month prior to screening may be included in the study; patients with metastases to meninges will be excluded;
- Known hypersensitivity to any of the active ingredients or excipients of ACR246, or documented history of allergy to protein drugs, experienced other serious allergic reactions, for which, the patient is not suitable to receive ACR246 as assessed by the investigator;
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 |
|---|---|---|
| ACR246 for injection80 mg/vial | Drug | ACR246 for injection |
Primary outcome
Safety and tolerability:
Time frame: 21days
Incidence and characteristics of adverse events (AEs), serious adverse events (SAEs) and dose-limiting toxicities (DLTs).
8 secondary outcomes
PK parameters of ACR246（Cmax）
Time frame: 21days
PK parameters of ACR246（Tmax）
Time frame: 21days
PK parameters of ACR246（t1/2）
Time frame: 21days
PK parameters of ACR246（AUC0-t）
Time frame: 21days
PK parameters of ACR246（AUC0-∞）
Time frame: 21days
PK parameters of ACR246（CL）
Time frame: 21days
PK parameters of ACR246（Vd）
Time frame: 21days
PK parameters of ACR246（mean residence time (MRT)）
Time frame: 21days
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 24 Nov 2025.
- Individual participant dataSharing planned: No
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ACR246 for injection in people with Advanced Solid Tumors, run by Hangzhou Adcoris Biopharmacy Co., Ltd at 6 sites 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 25 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 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 Lina Chen (0571-83580689, chenln@adcoris.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability: (time frame: 21days). 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 24 Nov 2025.