A Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SKB105 for Injection in Participants With Advanced Solid Tumors
Overview
- Phase
- Phase 1
- Status
- Not yet recruiting
- Enrollment
- 256
- 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 SKB105 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 multicenter, open-label, Phase 1/2 clinical study to evaluate the safety, tolerability, Pharmacokinetics(PK) characteristics, immunogenicity, and efficacy of SKB105 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 during the screening period;
- •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.
- •The toxicity of previous anti-tumor treatments has not been relieved, defined as the toxicity has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Version 6.0 grade 0 or
- •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.
Arms & Interventions
SKB105 monotherapy
Subject will be dosed with SKB105 for injection every 3 weeks(q3w)
Intervention: SKB105 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 first 21 days and is at least possibly related to study drug.
Objective Response Rate (ORR)
Time Frame: up to 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 3 years)
- Duration of Response (DOR)(Up to 3 years)
- Overall Survival (OS)(Up to 3 years)