Actively Recruiting
A Phase I First-in-Human Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of SWA1211 Tablets in Subjects With Advanced Solid Tumors
Led by Beijing StoneWise Technology Co., Ltd · Updated on 2026-01-23
60
Participants Needed
1
Research Sites
137 weeks
Total Duration
On this page
Sponsors
B
Beijing StoneWise Technology Co., Ltd
Lead Sponsor
S
Shanghai East Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this phase I, first-in-human, open-label study is to evaluate the safety, tolerability, PK, and preliminary anti-tumor activity of SWA1211 in subjects with advanced solid tumors. It includes a Phase Ia dose escalation study and a Phase Ib dose expansion study. The main questions it aims to answer are: 1. Assess the safety and tolerability of SWA1211 in subjects with advanced solid tumors. 2. Identify the dose-limiting toxicity (DLT) to establish the maximum tolerated dose (MTD) or maximum administered dose (MAD) and/or the recommended Phase II dose (RP2D) of SWA1211. 3. Assess the PK characteristics of SWA1211. 4. Evaluate the preliminary anti-tumor activity of SWA1211.
CONDITIONS
Official Title
A Phase I First-in-Human Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of SWA1211 Tablets in Subjects With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects aged 18 to 75 years, male or female, willing and able to sign informed consent
- Histologically or cytologically confirmed advanced solid tumors with no effective standard treatment available
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 3 months
- Adequate bone marrow, coagulation, liver, kidney, and cardiac function as specified
- At least one evaluable lesion for Phase Ia or measurable lesion for Phase Ib as per RECIST v1.1
- Agree to use reliable contraception during the study and for 3 months after the last dose if of reproductive potential
- Able to communicate well and follow study requirements
You will not qualify if you...
- Allergy to SWA1211 tablets or any of their ingredients
- Prior treatment with HPK1 inhibitors
- Recent anti-tumor treatments within specified washout periods before study drug
- Recent use of CYP3A4, CYP2C8, P-gp inhibitors or inducers, acid-reducing agents within specified timeframes
- Major surgery, significant trauma, or invasive dental procedures within 4 weeks before dosing
- Serious unhealable wounds or ulcers within 4 weeks before dosing
- Significant bleeding events within 6 months or high bleeding risk
- Unresolved adverse reactions from prior anti-tumor therapies above grade 1
- History of severe immune-related adverse events from immunotherapy
- Uncontrolled central nervous system metastases
- Recent gastrointestinal perforation, fistula, abscess, or high risk for these conditions
- Inability to take oral medication or conditions affecting gastrointestinal absorption
- Active autoimmune diseases or history likely to relapse (with some exceptions)
- Active infections including HIV, active HBV or HCV with high viral load
- Serious cardiovascular or cerebrovascular diseases or uncontrolled hypertension
- Clinically uncontrolled third-space effusions
- History of interstitial lung disease or pneumonitis requiring treatment
- History of other malignancies within 5 years except certain controlled skin or cervical cancers
- History of drug abuse, mental disorders, or poor compliance
- Pregnant or breastfeeding women
- Inability to tolerate venous blood sampling
- Other serious systemic diseases or investigator judgment making participation unsuitable
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
D
Desheng Kong, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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