Solid Tumor
Conditions
Brief summary
A Phase I, Multi-center, Open-label Study with Dose-escalation and Multiple Expansion Cohorts to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of JYB1907 in Subjects with Advanced Solid Tumors
Detailed description
Dose escalation This part is meant to evaluate the safety, tolerability, PK, immunogenicity, preliminary antitumor activity, the MTD and RP2D of JYB1907 in patients with histologically or cytologically confirmed advanced solid tumors. Expansion cohort The antitumor activity, safety, tolerability, PK and immunogenicity of JYB1907 will be further evaluated in other cohorts.
Interventions
DRUGJYB1907
for injection
Sponsors
Jemincare
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Able to provide written informed consent voluntarily; 2. Age ≥18, male or female; 3. Have at least one evaluable lesion (Dose escalation) or measurable lesion; 4. Expected survival ≥12 weeks； 5. Eastern Cooperative Oncology Group (ECOG) performance status ≤2;
Exclusion criteria
1. Received within 4 weeks before the initial treatment, or scheduled during the study to receive a major surgery, live attenuated vaccines, or any anti-tumor therapy. 2. With severe tumor complications. 3. Pregnant or lactating women, or positive serum pregnancy test; 4. Concurrent participation in another interventional study； 5. With other diseases or clinical abnormalities assessed by the Investigator as ineligible.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | until either 28 days after last dose of study drug or initiation of new anticancer therapy, whichever occurs first. | Adverse events, and changes from baseline in vital signs,etc. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum concentrations of JYB1907 | until 28 days after last dose of study drug | JYB1907 assessed by pre-specified methods, and related pharmacokinetic parameters analysis |
| Serum concentrations of Immunogenicity Analysis | until 28 days after last dose of study drug | immunogenicity of JYB1907 assessed by pre-specified methods, and related immunogenic features analysis |
| Serum concentrations of Preliminary antitumor activity | until 28 days after last dose of study drug | To evaluate the preliminary antitumor activity of JYB1907 in patients with advanced solid tumors assessed by Recist1.1 |
Contacts
Primary ContactGuorui Wang
Outcome results
None listed