Actively Recruiting
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
Led by Hangzhou Adcoris Biopharmacy Co., Ltd · Updated on 2025-11-24
77
Participants Needed
6
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to sign informed consent and able to complete all study procedures
- Male or female, aged 18 to 75 years
- For Phase I: Histologically or cytologically confirmed recurrent or metastatic unresectable advanced solid tumors with disease progression after systemic standard therapy or no standard therapy
- For Phase IIa: Same as Phase I plus specific tumor types including esophageal cancer with ≥2 prior chemotherapy lines, colorectal cancer with ≥2 prior chemotherapy lines, NSCLC with driver gene status and prior therapies as specified, ovarian cancer with prior chemotherapy and PARP inhibitor if BRCA 1/2 mutated, metastatic castration-resistant prostate cancer with prior systemic therapy, and other solid tumors with progression after standard care or unsuitable for standard care
- Positive for 5T4 expression (Phase IIa only)
- At least one evaluable lesion (Phase I) or measurable lesion (Phase IIa) by imaging per RECIST v1.1
- Toxicity from prior therapies recovered to Grade ≤1 per NCI-CTCAE v5.0 except alopecia or tolerated events
- ECOG performance status score ≤1
- Adequate bone marrow, liver, kidney, and coagulation function
- Expected survival ≥3 months
- Left ventricular ejection fraction (LVEF) ≥50%
- Agree to use acceptable contraceptive methods during study and for 6 months after last dose (for patients of reproductive potential)
You will not qualify if you...
- Presence of other primary malignant tumors except resolved non-invasive basal or squamous cell carcinoma, cervical carcinoma in situ, or other tumors with >5-year disease-free survival, or stable tumors benefiting from study participation (Phase I only)
- Received systemic antitumor therapies within 4 weeks or immunomodulators within 2 weeks before first dose
- Prior treatment with any 5T4-targeted therapy
- Active brain or spinal cord metastases requiring treatment, or metastases to meninges
- Known allergy to ACR246 components or serious allergic reactions
- Severe heart disease including symptomatic congestive heart failure (NYHA Class ≥2), recent myocardial infarction or unstable angina
- Serious arrhythmias requiring medication or abnormal ECG parameters
- Uncontrolled hypertension despite medication
- Severe pulmonary conditions requiring oxygen, interstitial lung disease, radiation pneumonitis, pulmonary fibrosis, or active lung disease
- Serious or uncontrolled systemic diseases
- Positive tests for active hepatitis B, hepatitis C, syphilis, HIV, or uncontrolled infections
- Major surgery or serious trauma within 4 weeks prior to first dose or planned major surgery during study
- Pregnant or lactating women
- Serious arterial or venous thrombosis within 1 year or hemorrhagic diathesis within 30 days prior to enrollment
- Use of strong CYP450 3A inhibitors or inducers that cannot be stopped
- Active eye disorders requiring intervention
- Other conditions deemed unsuitable by investigator such as poor compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
2
Beijing Tumor Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
3
Zhejiang Cancer Hospital
Zhejiang, Hangzhou, China, 310022
Actively Recruiting
4
Shandong First Medical University affiliated Cancer Hospital of Shandong
Shandong, Jinan, China, 250117
Actively Recruiting
5
ShangHai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
6
ShangHai Sixth People's Hospital
Shanghai, Shanghai Municipality, China, 200233
Actively Recruiting
Research Team
L
Lina Chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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