Advanced Solid Tumors
Conditions
Brief summary
This is a multicenter, open-label, first-in-human study to evaluate the safety,efficacy, and PK/PD characteristics of SIM0508 as a single agent and in combination with olaparib in participants with locally advanced/metastatic solid tumors.
Interventions
DRUGSIM0508 Tablets
Every 28 days is one cycle. Multiple dose levels of SIM0508 will be explored in dose escalation, and determine the maximum tolerated dose.
DRUGSIM0508 in combination with olaparib
Every 28 days is one cycle.Multiple dose levels of SIM0508 and olaparib will be explored in dose escalation, and determine the maximum tolerated dose.
Sponsors
Shanghai Xianxiang Medical Technology Co., Ltd.
Jiangsu Simcere Pharmaceutical Co., Ltd.
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. Voluntary participation and signature of informed consent form. 2. Participants with histologically confirmed ovarian cancer, prostate cancer,breast cancer , or pancreatic cancer. 3. ECOG score of 0 or 1. 4. Expected survival ≥ 12 weeks.
Exclusion criteria
1. Active hepatitis B (HBsAg or HBcAb positive and HBV DNA≥1×104 copies/mL or≥2000 international unit \[IU\]/mL) or hepatitis C (HCV antibody positive and HCV RNA≥ULN) infection; participant with HBsAg positive or detective HBV-DNA at screening should receive antiviral treatment as per local practice during the study. 2. Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS). 3. Participants unable to swallow study drug and participants with gastrointestinal disorders likely to interfere with absorption of the study drug. 4. Toxicities from previous anticancer therapies have not resolved (e.g to ≤ Grade 1). 5. Pregnant or nursing (lactating) women; other women of childbearing potential, unless the blood pregnancy test within 7 days of first dose of study drug is negative, and participants agree to use highly effective contraceptive methods from signing of informed consent to 180 days after the last dose of SIM0508 or olaparib, whichever comes later. 6. Male partinipants with female partners of reproductive potential, unless they agree to use highly effective contraceptive methods from signing of informed consent to 180 days after the last dose of SIM0508 and 90 days after the last dose of olaparib, whichever comes later.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose-limiting toxicity (DLT) | At the end of Cycle 1 (each cycle is 28 days) | Primary Endpoints |
Countries
China
Contacts
Primary ContactJuan Wen Wang
Outcome results
None listed