A Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SKB103 for Injection in Participants With Advanced Solid Tumors
Overview
- Phase
- Phase 1
- Status
- Not yet recruiting
- Enrollment
- 277
- Locations
- 2
- Primary Endpoint
- Number of subjects achieving Dose-limiting toxicity (DLT)
Overview
Brief Summary
This is a phase 1/2 clinical study to evaluate the safety and efficacy of SKB103 in participants with advanced solid tumors. The study includes a dose escalation stage, a dose expansion stage, and a indication expansion stage.
Detailed Description
This is a multi-center, open-label, phase 1/2 clinical study to evaluate the safety, tolerability, pharmacokinetics (PK) characteristics, immunogenicity, and efficacy of SKB103 in participants with advanced solid tumors. The study includes a Phase 1 dose escalation stage, a Phase 1 dose expansion stage, and a Phase 2 indication expansion stage.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants voluntarily joined this study and signed an informed consent form.
- •The age at the time of signing the informed consent form must be between 18 and 75 years.
- •Participants with histologically or cytologically confirmed advanced solid tumors who have failed standard therapy, have no standard therapy available, or are intolerant to standard therapy.
- •Participants should provide tumor tissue samples for biomarker testing as much as possible.
- •Researchers evaluated based on Response Evaluation Criteria in Solid Tumors(RECIST) Version 1.1 that there is at least one measurable lesion present.
- •Eastern Cooperative Oncology Group (ECOG) score is 0 or
- •Expected survival period ≥ 12 weeks.
- •Participants have sufficient bone marrow, liver, kidney, and coagulation functions.
- •Male and female participants must agree to use highly effective contraceptive methods during the study period.
Exclusion Criteria
- •Participants known to have meningeal metastasis, brainstem metastasis, spinal cord metastasis and/or compression, and active central nervous system (CNS) metastasis.
- •Patients with other malignant tumors within 3 years before the first administration.
- •There are serious heart or vascular diseases or high-risk factors present.
- •According to researchers' judgment, it is an uncontrollable systemic disease.
- •There are pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring repeated drainage (\>1 time/week).
- •History of interstitial lung disease or non infectious pneumonia.
- •There are other lung diseases that may interfere with drug-related pulmonary toxicity.
- •Severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or a history of corneal diseases that hinder/delay corneal healing.
- •There is a risk of developing esophagotracheal fistula or esophageal pleural fistula, or tumor invasion or compression of surrounding important organs and blood vessels accompanied by related clinical symptoms.
- •Within 3 months prior to the first administration, there have been clinical symptoms of intestinal obstruction, gastrointestinal perforation or fistula, urethral fistula, and abdominal abscess.
Arms & Interventions
SKB103 monotherapy
Participants will be dosed with SKB103 for injection every 3 weeks(q3w)
Intervention: SKB103 for injection monotherapy (Drug)
Outcomes
Primary Outcomes
Number of subjects achieving Dose-limiting toxicity (DLT)
Time Frame: From date of initial dose until up to 21 days for treatment
DLT is defined as an adverse event (AE) that meets protocol-defined DLT criteria during the first 21 days and is at least possibly related to the study drug.
Objective response rate (ORR)
Time Frame: Up to approximately 3 years
The sum of the number of cases with Complete Response (CR) and Partial Response (PR) in all treated tumor patients (CR + PR) divided by the total number of cases.
Secondary Outcomes
- Progression Free Survival (PFS)(Up to approximately 3 years)
- Duration of Response (DOR)(Up to approximately 3 years)
- Overall Survival (OS)(Up to approximately 3 years)
- Maximum observed plasma concentration (Cmax) of SKB103-ADC, SKB103-TAB, and free KL610348.(Up to approximately 3 years)