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

NCT07363967 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: SWC0102
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Assess the safety and tolerability of SWA1211 in subjects with advanced solid tumors.
2. 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. 3.Assess the PK characteristics of SWA1211.
4. 4.Evaluate the preliminary anti-tumor activity of SWA1211.

Conditions

Solid Tumor Malignancies

Outcome Measures

Primary Outcomes (1)

• Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

  1\. Safety profile: adverse events (AEs, including irAEs), clinical laboratory tests (hematology, urinalysis, blood biochemistry, coagulation tests, cardiac enzymes, and cardiac troponin I (cTnI)), physical examination, vital signs, 12-lead electrocardiograms (12-lead ECG), ECOG, etc.

  From the first dose of study drug(s) to 90 days after the last dose or initiation of a new anticancer therapy, whichever occurs first; up to approximately 12 months

Study Arms (2)

Phase 1a: Dose Escalation Study

EXPERIMENTAL

An accelerated titration design (ATD) combined with a traditional 3+3 dose escalation design of SWA1211 will be used. Six dose-escalation cohorts are planned.

Drug: SWA1211

Phase 1b: Dose Expansion Study

EXPERIMENTAL

The trial will proceed to the dose expansion study after completion of dose escalation (Phase 1a) for SWA1211, with 1 to 2 cohorts, each with 20 \~ 30 subjects.

Drug: SWA1211

Interventions

SWA1211 DRUG

Planned doses administered orally as a tablet daily

Phase 1a: Dose Escalation Study; Phase 1b: Dose Expansion Study

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who are fully informed of the purpose, nature, method, and possible adverse reactions of the study, and are willing to participate in the study and sign the informed consent document before any study procedure.
• Subjects aged between 18 to 75 years old, male or female when signing the informed consent form (ICF).
• Study population:
• Phase Ia (Dose Escalation Study): Subjects with histologically or cytologically confirmed advanced solid tumors, who have failed standard treatments, have no available standard treatment, or are not suitable for standard treatment at present.
• Phase Ib (Dose Expansion Study): Subjects with histologically or cytologically confirmed advanced solid tumors, who have failed standard treatments, have no available standard treatment, or are not suitable for standard treatment at present. The specific tumor types will be adjusted based on the results of Phase Ⅰa (dose escalation study).
• Tumor tissue samples (preferable but not mandatory; fresh or archived) from patients will be collected during the screening period to assay the expression of HPK1. However, patient enrollment is not based on HPK1 expression levels.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy of at least 3 months.
• The function of bone marrow reserve and organs must meet the following requirements (without ongoing continuous supportive treatment):
• Bone marrow reserve: Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelet count (PLT) ≥ 90 × 109/L, and hemoglobin (Hgb) ≥ 9.0 g/dL (no blood transfusion or hematopoietic stimulating factor therapy within 14 days).
• Coagulation function: Activated partial thromboplastin time (APTT) prolongation ≤ 1.5 × upper limit of normal (ULN), and international normalized ratio (INR) ≤ 1.5.
• Liver function: Total bilirubin (TBIL) ≤ 1.5 × ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (if there is liver metastasis, ALT or AST ≤ 5 × ULN).
• Kidney function: Creatinine clearance rate ≥ 60 mL/min (using the Cockcroft-Gault formula, see Appendix 1 for details); qualitative urine protein ≤ 1+, or qualitative urine protein ≥ 2+, but 24-hour urine protein \< 1 g.
• Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%; corrected QT interval (QTcF) ≤ 470 ms regardless of sex.
• Subjects must have at least 1 evaluable lesion (only for Phase Ⅰa) or at least 1 measurable lesion (only for Phase Ⅰb) as defined by RECIST v1.1.

You may not qualify if:

• Known to be allergic to SWA1211 tablets or any of their excipients (Polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer; Vitamin E polyethylene glycol succinate, VE-TPGS 1000; Hypromellose; Propyl gallate; Methanol; Dichloromethane; Sodium lauryl sulfate; Microcrystalline cellulose; Manitol; Crospovidon; Silicon dioxide; Sodium stearyl fumarate; Film coating premix (Gastric dissolve type)).
• Prior treatment with hematopoietic progenitor cell kinase 1 (HPK1) inhibitors.
• Receipt of chemotherapy, radiotherapy, biological therapy, endocrine therapy, immune checkpoint inhibitor therapy, or other anti-tumor therapies within 4 weeks or 5 times the half-life of the drugs (whichever is longer) before the first dose of IP, except for the following items:
• )Have used nitrosourea or Mitomycin C within 6 weeks before the first dose of IP.
• )Have used oral fluorouracil and small molecule targeted drugs within 2 weeks or 5 times the half-life of the drugs before the first dose of IP (whichever is longer).
• )Have used herbal therapies with anti-tumor indications within 2 weeks before the first dose of IP.
• Have received other clinical study drugs or treatments within 4 weeks before the first dose of IP, or still being within the safe follow-up period of other clinical study drugs or treatments.
• Have received systemic glucocorticoids (\> 10 mg/day of prednisone or equivalent), or other immunosuppressants within 14 days before the first dose of IP, with the following exceptions:
• Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent).
• Topical, ocular, intra-articular, intranasal, or inhalational corticosteroid with minimal systemic absorption.
• Short course (≤ 7 days) of corticosteroids prescribed prophylactically (e.g., for contrast dye allergy) or for the treatment of a non-autoimmune condition (e.g., delayed-type hypersensitivity reaction caused by a contact allergen).
• Use of CYP3A4 or CYP2C8 strong inducers or inhibitors within 14 days or 5 times the half-life of the drugs (whichever is longer) before the first dose of IP (see Appendix 3 for details).
• Use of P-gp strong inhibitors, or P-gp substrates within 14 days or 5 times the half-life of the drugs (whichever is longer) before the first dose of IP (see Appendix 3 for details).
• Use of acid-reducing agents (ARAs) (e.g., histamine H2-receptor antagonists (H2 blockers), and proton pump inhibitors (PPIs)) within 14 days or 5 times the half-life of the drugs (whichever is longer) before the first dose of IP.
• Major organ surgery (excluding biopsy) or significant trauma or invasive dental procedures (such as tooth extraction, dental implants) within 4 weeks before the first dose of IP, or the requirement for elective surgery during the study period.

Sponsors & Collaborators

• Shanghai East Hospital: collaborator
• Shanghai Cancer Centre: collaborator
• Zhejiang Cancer Hospital: collaborator
• Beijing StoneWise Technology Co., Ltd: lead

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Central Study Contacts

Desheng Kong, Ph.D

CONTACT

+86-13764289105; clinical@stonewise.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: January 23, 2026
• Study Start: June 13, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

CN (1)