Clinical trial NCT05906537: SKB410 for Injection in Solid Tumors
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SKB410 for Injection in Subjects With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-06-18
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a multicenter, open-label, multiple-dose dose finding and expansion study to evaluate the safety, tolerability, pharmacokinetic(PK) profile, and anti-tumor efficacy of SKB410 for injection in patients with advanced solid tumors.

Detailed description: This is a multicenter, open-label, multiple-dose dose finding and expansion study to evaluate the safety, tolerability, PK profile, and anti-tumor efficacy of SKB410 for injection in patients with advanced solid tumors.This study consists of two phases, Phase Ia and Phase Ib: Phase Ia is a dose escalation phase, and subjects with advanced solid tumors will be enrolled to receive SKB410 for Injection; Phase Ib is a dose expansion phase, and the expansion dose(s) for specific cancer will be determined based on Phase Ia result.

Eligibility criteria: Inclusion Criteria:

1. At the time of signing the ICF: age ≥ 18 years, male or female.
2. Phase Ia: subjects with histologically or cytologically confirmed locally advanced or metastatic solid tumors who have failed/are intolerant/ineligible to or do not have standard therapy, and have at least one measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
3. Eastern Cooperative Oncology Group (ECOG) score of 0 to 1.
4. Expected survival ≥ 3 months.
5. Subjects with adequate organ and bone marrow function confirmed by laboratory results within 3 days prior to the first dose.
6. Subjects of childbearing potential (male or female) must use effective medical contraception during the study until 6 months after the last dose.
7. Ability to understand and willingness to sign ICF, and will be able to comply with the protocol-specified visits and relevant procedures.

Exclusion Criteria:

1. Has received anti-tumor therapy, including chemotherapy, targeted therapy, tumor immunotherapy, and traditional Chinese medicinal products with anti-tumor indications, within 4 weeks prior to the first dose or within 5 half-lives of known drugs (whichever is shorter).
2. Has received radiotherapy within 4 weeks prior to the first dose.
3. Has had major surgery within 4 weeks prior to the first dose.
4. Has received strong cytochrome P450 (CYP3A4) inhibitors or inducers (see Annex 4) within 2 weeks prior to the first dose or within 5 half-lives of known drug, whichever is longer.
5. Has not recovered to normal or ≤ Grade 1 from any AE and/or complication due to any prior therapy (except alopecia or pigmentation).
6. Has known history of allergy to any component of SKB410 or other monoclonal antibodies.
7. Has a known previous or concurrent other malignancies within 5 years prior to signing the ICF.
8. Presence of active central nervous system (CNS) metastases and/or carcinomatous meningitis.
9. Has active autoimmune disease with systemic therapy or immunosuppressive therapy within 2 years prior to signing the ICF.
10. Has uncontrolled or severe cardiovascular disease.
11. Has uncontrolled systemic diseases.
12. Presence of clear neurological or psychiatric disorder.
13. Has active infection requiring systemic.
14. Has human immunodeficiency virus (HIV) infection; has any active viral hepatitis.
15. Pregnant or lactating.
16. Has prior autologous/allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
17. Has any other conditions such as medical history, treatment and laboratory abnormalities that may confound the study results, interfere with the subject's compliance, or impair the subject's interests, as assessed by the investigator or the sponsor.

Primary outcomes:
measure: Phase Ia :Number of subjects achieving Dose-limiting toxicity (DLT)
timeFrame: From data of initial dose until up to 28 days for treatment
measure: Phase Ia :Maximum Tolerated Dose (MTD)
timeFrame: From data of initial dose until up to 28 days for treatment
measure: Phase Ib:ORR
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
measure: ORR
timeFrame: through study completion, an average of 2 years
measure: DCR
timeFrame: through study completion, an average of 2 years
measure: DOR
timeFrame: through study completion, an average of 2 years
measure: PFS
timeFrame: through study completion, an average of 2 years
measure: OS
timeFrame: through study completion, an average of 2 years
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
References: