Clinical trial NCT05309512: Clinical Study of KN052 in Chinese Subjects With Advanced Solid Tumors
Official title: A Phase Ia/Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Antitumor Activity of KN052 in Chinese Subjects With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Advanced Solid Tumor
Lead sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Sponsor class: INDUSTRY
First posted: 2022-04-04
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase Ia/Ib open, multicenter study of solid tumor subjects in China.Including dose increasing period and cohort expansion period.A BOIN design is used in the dose escalation phase,a total of 8 dose groups were designed.In the expansion phase of the cohort, 15 to 30 subjects will be enrolled in a specific tumor type (liver cancer, stomach cancer, kidney cancer, melanoma, urothelial carcinoma, and other tumors determined by the SMC).


Eligibility criteria: Inclusion Criteria:

1. The subject can understand the informed consent, participate in and sign the informed consent voluntarily;
2. Subjects are at least 18 years old and \<80 years old on the day of signing the informed consent, male or female, and are willing to follow the study procedures;
3. Solid tumors were confirmed histologically or cytologically. Subjects in the dose escalation phase were late unresectable or metastatic entities Patients with cancer must have received standard care and have no other standard care options with a proven survival benefit; or Subjects with refractory solid tumors who could not tolerate or had contraindications to standard treatments, including chemotherapy, Targeted therapy;
4. Measurable lesions at baseline according to RECIST 1.1; If subject has only 1 measurable disease at baseline The lesion area must not have received previous radiotherapy, or there is evidence of significant progression of the lesion after the end of radiotherapy;
5. ECOG score 0 or 1;
6. The laboratory test met the standard within 7 days before the first administration;
7. Life expectancy ≥3 months;
8. Fertile female subjects must have a negative serum pregnancy test within 7 days prior to first dosing;
9. Fertile female subjects or fertile male subjects with a partner agree to use highly effective contraception beginning 7 days before first dosing (annual failure rate less than 1%) until 24 weeks after completion of dosing.

Exclusion Criteria:

1. Subjects with untreated active BMS; Subjects with pia meningeal metastasis;
2. Received any other medication within 28 days prior to administration or 5 half-lives, whichever is shorter, but at least 2 weeks Interventional clinical trial therapy or other systemic chemotherapy, immunotherapy, targeted therapy and endocrine therapy;
3. Major surgery (transabdominal, transthoracic, etc.) was performed within 28 days prior to administration; Not including diagnosis Sexual puncture or peripheral vascular access replacement);
4. Had received radical radiotherapy within 3 months before administration in this study; 2 weeks prior to administration of palliative radiotherapy and radiotherapy are permitted Dose in line with local standards for palliative care;
5. Systemic corticosteroid (≥10 mg/ day prednisone, or other corticosteroid equivalent) or immunosuppressant treatment is required for 7 consecutive days within 14 days prior to the first administration of the drug in this study;
6. Received live vaccine (including live attenuated vaccine) within 28 days prior to administration;
7. Past or current interstitial pneumonia/lung disease requiring systematic hormone therapy;
8. Previous or current autoimmune diseases;
9. Other malignant tumors within 5 years prior to first administration;
10. Suffering from uncontrolled complications;
11. Toxicity of previous antitumor therapy did not return to CTCAE grade ≤1 (NCI-CTCAE V5.0) or baseline level;
12. Previous history of allogeneic bone marrow or organ transplantation;
13. In addition to anti-PD-(L)1 drugs or anti-CTLA-4 drugs, other antibodies/drugs (immune checkpoint) targeting T cell coregulatory proteins, such as OX40, 4-1BB,LAG3, TIM3, TIGIT or anti-CD127, have been used in the past;
14. Previous history of intolerance to anaphylaxis to antibody drugs (grade ≥3 NCI-CTCAE V5.0); Any speed before A history of allergic reactions or uncontrolled asthma; Significant prior drug allergy;
15. Pregnant and/or breastfeeding women;
16. Other conditions that may affect the safety or compliance of the drug treatment in this study.

Primary outcomes:
measure: MTD（ Maximum tolerated Dose）
timeFrame: Throughout the duration of the study，About 1 year
measure: ORR（Objective Response Rate)
timeFrame: Throughout the duration of the study，About 1 year
measure: DOR(Duration Of Response)
timeFrame: Throughout the duration of the study，About 1 year
Secondary outcomes:
measure: The probability of adverse events
timeFrame: Throughout the duration of the study，About 1 year
measure: Frequency of interruption, delay, and termination of dosing
timeFrame: Throughout the duration of the study，About 1 year
measure: Frequency of immunogenicity
timeFrame: Throughout the duration of the study，About 1 year
measure: Cmax of KN052
timeFrame: Throughout the duration of the study，About 1 year
measure: Tmax of KN052
timeFrame: Throughout the duration of the study，About 1 year
measure: AUC(0-T) for KN052
timeFrame: Throughout the duration of the study，About 1 year
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
References: