Actively Recruiting
An Open-Label, Multi-Cohort Study Evaluating the Efficacy and Safety of ABP1011T Tablets in Patients With Advanced Solid Tumors
Led by Shanghai AB PharmaTech Ltd. · Updated on 2026-01-07
110
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Shanghai AB PharmaTech Ltd.
Lead Sponsor
G
GCP ClinPlus Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of ABP1011T tablets in participants with advanced solid tumors, including small cell lung cancer, esophageal cancer, cervical cancer, bladder cancer, and renal cell carcinoma. This open-label, multi-cohort Phase IIb study builds on prior safety and efficacy data from an earlier clinical trial. Priority enrollment is given to patients with small cell lung cancer who have failed at least two prior systemic therapies. Participants receive ABP1011T tablets orally once daily on an empty stomach with water, avoiding food for at least one hour before and after dosing. Treatment follows a continuous 21-day cycle, and the study includes multiple cohorts: Cohort A focuses on small cell lung cancer patients, while Cohort B includes other advanced solid tumors. The study treatment is administered continuously throughout the trial. During the study, participants undergo regular assessments to monitor treatment effects and safety, including evaluations of tumor response using the objective response rate (ORR) over approximately two years. Secondary outcomes include duration of relief, progression-free survival, disease control rate, sustained response rate, overall survival, and treatment-related adverse events. Participants are monitored closely for up to two years to assess the impact of the study drug.
CONDITIONS
Brief Title
A Study Evaluating the Efficacy and Safety of ABP1011T Tablets in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign informed consent and follow the study protocol
- Age between 18 and 75 years, any gender
- Expected survival of at least 12 weeks
- ECOG performance status of 0 or 1
- Diagnosed with advanced solid tumors confirmed by biopsy, including priority enrollment for certain cancers such as small cell lung cancer with at least two prior systemic therapies
- At least one measurable lesion per RECIST v1.1 criteria
- Recovered from prior treatment side effects with no safety risk
- Blood pressure controlled: systolic ≤140 mmHg and diastolic ≤90 mmHg without recent medication changes
- Adequate bone marrow, liver, kidney, and coagulation function per specified laboratory values
- Negative pregnancy test for women of childbearing potential and agreement to use effective contraception; men with partners of childbearing potential must also use contraception during and for 6 months after the study
You will not qualify if you...
- History or current presence of other malignant tumors except certain completely resected cancers without recurrence
- Known allergy to the study drug or similar agents
- Recent major surgery, severe trauma, or antitumor treatments within specified timeframes before study drug administration
- Recent use of certain medications affecting drug metabolism or heart rhythm
- Use of antiplatelet or anticoagulants that cannot be stopped
- Known unstable or symptomatic brain or central nervous system metastases
- Advanced disseminated visceral disease with risk of life-threatening complications or recent fluid drainage procedures
- Tumor invasion of major vessels or adjacent organs posing high risk of hemorrhage
- Recent serious cardiovascular conditions or events
- Electrolyte disturbances
- Uncontrolled systemic diseases such as diabetes
- Current acute pulmonary diseases or treatable interstitial lung conditions
- Gastrointestinal bleeding risks or unhealed gastrointestinal perforations
- Active infections including hepatitis B or C, tuberculosis, HIV, or syphilis
- Conditions impairing oral medication absorption
- History of significant neurological or psychiatric disorders
- Alcohol or drug dependence, needle or blood phobia
- Inability to avoid certain foods or beverages during the trial
- Participation in other investigational drug studies recently
- Pregnant or breastfeeding women
- Any other conditions deemed unsuitable by the investigator
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 2 years
Participants take ABP1011T tablets once daily on an empty stomach in repeated 21-day cycles as continuous therapy.
Regular visits as per study protocol during treatment cycles
Trial Site Locations
Total: 8 locations
1
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Not Yet Recruiting
2
The First Affiliated Hospital of Nanyang Medical College
Nanyang, Henan, China
Not Yet Recruiting
3
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Not Yet Recruiting
4
Liaocheng Second People's Hospital
Liaocheng, Shandong, China
Actively Recruiting
5
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
6
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Not Yet Recruiting
7
Neijiang First People's Hospital
Neijiang, Sichuan, China
Actively Recruiting
8
Shanghai East Hospital
Shanghai, China
Actively Recruiting
Research Team
H
Haiping WANG, PhD
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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