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
21 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
Researchers are evaluating the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of SWA1211 tablets in people with advanced solid tumors. This Phase I, first-in-human, open-label study aims to find the maximum tolerated or recommended dose of SWA1211 and understand its side effects and how the body processes the drug. The study is sponsored by Beijing StoneWise Technology Co., Ltd and includes both dose escalation and dose expansion phases. The study uses an accelerated titration combined with a traditional 3+3 dose escalation design in Phase 1a, with six planned dose-escalation groups. After completing dose escalation, the trial moves to Phase 1b, a dose expansion study with 1 to 2 groups of 20 to 30 participants each. SWA1211 is given orally as tablets daily. The study does not use blinding and participants are randomly assigned. Participants will be monitored for adverse events and serious adverse events from the first dose until 90 days after the last dose or start of new cancer treatment, up to about 12 months. Researchers will assess safety, collect blood samples to study drug levels, and evaluate anti-tumor effects. The study requires participants to have certain health and organ function criteria and includes tumor tissue sample collection during screening if possible. Participants may be involved in regular assessments throughout the study duration.
CONDITIONS
Brief 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 who understand the study and sign informed consent.
- Aged 18 to 75 years, male or female.
- Histologically or cytologically confirmed advanced solid tumors with no effective standard treatment options.
- ECOG performance status of 0 or 1.
- Life expectancy of at least 3 months.
- Adequate bone marrow, coagulation, liver, kidney, and cardiac function without ongoing supportive treatment.
- At least 1 evaluable lesion for Phase 1a or 1 measurable lesion for Phase 1b as per RECIST v1.1.
- Agreement to use reliable contraception during and for 3 months after the study if of fertility potential.
- Ability to communicate well and follow study requirements.
You will not qualify if you...
- Allergy to SWA1211 tablets or any excipients.
- Prior treatment with HPK1 inhibitors.
- Recent chemotherapy, radiotherapy, biological, endocrine, immune checkpoint, or other anti-tumor therapies within specified washout periods.
- Recent use of other clinical study drugs or treatments within 4 weeks.
- Use of systemic glucocorticoids or immunosuppressants within 14 days except specific low-dose or topical uses.
- Use of strong CYP3A4, CYP2C8, P-gp inhibitors or substrates, or acid-reducing agents within 14 days.
- Major surgery or significant trauma within 4 weeks.
- Serious wounds, ulcers, or fractures within 4 weeks.
- Recent severe bleeding or high bleeding risk.
- Unresolved adverse reactions from prior therapies above grade 1.
- History of severe immune-related adverse events from immunotherapy.
- Uncontrolled CNS metastases.
- Recent gastrointestinal perforation or high risk for perforation/fistula.
- Unable to take oral medication or serious gastrointestinal absorption issues.
- Active autoimmune diseases or infections requiring systemic treatments.
- Serious cardiovascular or cerebrovascular diseases within 6 months.
- Clinically uncontrollable third-space effusions.
- History or evidence of interstitial lung disease or pneumonitis.
- Other malignancies within 5 years except some controlled skin and cervical cancers.
- Known drug abuse, mental disorders, pregnancy, breastfeeding, or inability to tolerate blood sampling.
- Other serious systemic diseases or conditions making participation unsafe.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 12 months
Participants receive planned doses of SWA1211 tablets taken orally daily to evaluate safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity.
Visits occur regularly during treatment for monitoring and dosing
Trial Site Locations
Total: 1 location
1
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
D
Desheng Kong, Ph.D
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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