Clinical trial NCT06548217: A Phase I Study of ONO-4538HSC in Subjects With Advanced or Metastatic Solid Tumors
Official title: An Open-label, Uncontrolled, Phase I Study of ONO-4538HSC in Subjects With Advanced or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced or Metastatic Solid Tumors
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2024-08-12
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multicenter, open-label, uncontrolled, phase I study to evaluate the tolerability, safety, pharmacokinetics, and efficacy of ONO-4538HSC administered subcutaneously in participants with advanced or metastatic solid tumors. This study consists of the tolerability confirmation part to determine the recommended dose for Japanese participants by evaluating the DLTs and the expansion part to evaluate the safety and pharmacokinetics and to explore the efficacy.


Eligibility criteria: Inclusion Criteria:

1. Patient with advanced or metastatic solid tumors
2. Patients have an ECOG performance status of 0 to 1
3. Patients with a life expectancy of at least 3 months

   \[Tolerability confirmation part\]
4. Patients who are refractory or intolerant to standard therapy or for whom no standard therapy is available

   \[Expansion part\]
5. Patients who are refractory or intolerant to standard therapy, or for whom no standard therapy is available, or for whom monotherapy with intravenous nivolumab is indicated according to the package insert

Exclusion Criteria:

1. Patients with a complication or history of severe hypersensitivity to any antibody product
2. Patients with severe complication

Primary outcomes:
measure: Dose-limiting toxicities (DLT)
timeFrame: 28 days
measure: Adverse event (AE)
timeFrame: UP to 100 days after the last dose
Secondary outcomes:
measure: Pharmacokinetics（serum concentration of Nivolumab）
timeFrame: Up to Cycle25 (each cycle is 28 days) and Post-treatment observation phase (28 days after the end of treatment phase)
Other outcomes:
measure: Overall response rate (ORR)
timeFrame: Through study completion, an average of 6 months
measure: Disease control rate (DCR)
timeFrame: Through study completion, an average of 6 months
measure: Overall survival (OS)
timeFrame: Through study completion, an average of 6 months
measure: Progression-free survival (PFS)
timeFrame: Through study completion, an average of 6 months
measure: Duration of response (DOR)
timeFrame: Through study completion, an average of 6 months
measure: Time to response (TTR)
timeFrame: Through study completion, an average of 6 months
measure: Best overall response (BOR)
timeFrame: Through study completion, an average of 6 months
measure: Percentage of change in the sum of tumor diameters of target lesions
timeFrame: Through study completion, an average of 6 months
measure: Maximum percent change in the sum diameters of the target lesions
timeFrame: Through study completion, an average of 6 months
measure: Anti-Nivolumab antibody
timeFrame: Up to Cycle25 (each cycle is 28 days) and Post-treatment observation phase (28 days after the end of treatment phase)
measure: Anti-rHuPH20 antibody
timeFrame: Up to Cycle25 (each cycle is 28 days) and Post-treatment observation phase (28 days after the end of treatment phase)
Locations:
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Niigata-shi
country: Japan
facility: Niigata Cancer Center Hospital
state: Niigata
city: Osaka-shi
country: Japan
facility: Osaka International Cancer Institute
state: Osaka
city: Osakasayama-shi
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center
state: Shizuoka
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Koto-ku
country: Japan
facility: The Cancer Institute Hospital Of JFCR
state: Tokyo
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Project Leader
role: STUDY_DIRECTOR
References: