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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 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-01-23

No results posted yet for this study

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. 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

  • Solid Tumor Malignancies

Interventions

DRUG

SWA1211

Planned doses administered orally as a tablet daily

Sponsors & Collaborators

  • Shanghai East Hospital

    collaborator OTHER

  • Shanghai Cancer Centre

    collaborator OTHER

  • Zhejiang Cancer Hospital

    collaborator OTHER

  • Beijing StoneWise Technology Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-13
Primary Completion
2027-09-01
Completion
2028-02-01
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07363967 on ClinicalTrials.gov