Clinical trial · Interventional
Study of SIM0508 Alone and in Combination in Patients With Advanced Solid Tumors
A Phase I, First-in-Human, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0508 Monotherapy and Combination Therapy in Adult Participants With Locally Advanced/Metastatic Solid Tumors
NCT06686745CI-TRIAL-00084418recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SIM0508 in combination with olaparib | Drug | — | UNRESOLVED |
| SIM0508 Tablets | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- SIM0508 mono dose escalation
- description
- Every 28 days is one cycle. Multiple dose levels of SIM0508 will be explored in dose escalation, and determine the maximum tolerated dose.
- interventionNames
- Drug: SIM0508 Tablets
- type
- EXPERIMENTAL
- label
- SIM0508 combination dose escalation
- description
- 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.
- interventionNames
- Drug: SIM0508 in combination with olaparib
- type
- EXPERIMENTAL
- label
- SIM0508 in combination with olaparib
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.